Barriers and facilitators influencing implementation of care technology for people with intellectual disabilities: A cross-sectional study among care professionals.

BACKGROUND: Implementation issues often hinder reaching the potential of care technology to improve daily lives of people with intellectual disabilities. We investigated barriers to and facilitators of implementing different technology modalities (app/social robot/sensor/domotics) in long-term care. METHOD: Care professionals (N = 83) from 12 Dutch disability care organisations completed a customised measurement instrument for determinants of innovations (MIDI) questionnaire. RESULTS: Out of 27 determinants, 20 were identified as facilitators and 16 as barriers. We highlight common barriers: few colleagues who work with the technology; no (awareness of) formal ratification of technology use; no arrangements regarding turnover of staff using the technology; unsettling organisational changes; technological defects and limited IT preconditions. CONCLUSIONS: The results, which could be combined and compared across study sites, provide insight into which implementation determinants were already well addressed, and where there is ground to gain when implementing care technology in disability care organisations.

Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Alcohol Moderation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial.

BACKGROUND: Alcohol moderation (AM) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. OBJECTIVE: This study evaluates the effectiveness, cost-effectiveness, and cost-utility of MyCourse, a digital AM intervention, compared with a noninteractive digital information brochure for cancer survivors. METHODS: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months after randomization. The study was conducted on the web in the Netherlands from 2016 to 2019. Participants were adult 10-year cancer survivors drinking over the Dutch-recommended drinking guidelines (≤7 standard units [10 g of alcohol] per week) with the intention to moderate or quit drinking. Overall, 103 participants were randomized and analyzed: 53 (51.5%) in the MyCourse group and 50 (48.5%) in the control group. In the MyCourse group, participants had access to a newly developed, digital, minimally guided AM intervention, MyCourse-Moderate Drinking. The primary outcome was the self-reported number of standard drinks (10 g of ethanol) consumed in the past 7 days at the 6-month follow-up. The secondary outcome measures were alcohol-related problems as measured by the Alcohol Use Disorders Identification Test (AUDIT) and treatment satisfaction. For the health economic evaluation, health care costs, costs because of productivity losses, and intervention costs were assessed over a 12-month horizon. RESULTS: Alcohol use at the 6-month follow-up decreased by 38% in the MyCourse group and by 33% in the control group. No difference in 7-day alcohol use was found between the groups (B=2.1, 95% CI -7.6 to 3.1; P=.22) at any of the follow-ups. AUDIT scores for alcohol-related problems decreased over time in both groups, showing no significant difference between the groups (Cohen d=0.3, 95% CI -0.1 to 0.6; P=.21). Intervention costs per participant were estimated at US $279 for the MyCourse group and US $74 for the control group. The mean societal costs were US $18,092 (SD 25,662) and US $23,496 (SD 34,327), respectively. The MyCourse group led to fewer gained quality-adjusted life years at lower societal costs in the cost-utility analysis. In the cost-effectiveness analysis, the MyCourse group led to a larger reduction in drinking units over time at lower societal costs (incremental cost-effectiveness ratio per reduced drink: US $ -1158, 95% CI -1609 to -781). CONCLUSIONS: At 6 months, alcohol use was reduced by approximately one-third in both groups, with no significant differences between the digital intervention MyCourse and a noninteractive web-based brochure. At 12 months, cost-effectiveness analyses showed that MyCourse led to a larger reduction in drinking units over time, at lower societal costs. The MyCourse group led to marginally fewer gained quality-adjusted life years, also at lower societal costs. TRIAL REGISTRATION: Netherlands Trial Register NTR6010; https://www.trialregister.nl/trial/5433. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12885-018-4206-z.

Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Smoking Cessation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial.

BACKGROUND: Smoking cessation (SC) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. OBJECTIVE: This study aims to evaluate the effectiveness, cost-effectiveness, and cost-utility of a digital interactive SC intervention compared with a noninteractive web-based information brochure for cancer survivors. METHODS: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months. The study was conducted in the Netherlands over the internet from November 2016 to September 2019. The participants were Dutch adult smoking cancer survivors with the intention to quit smoking. In total, 165 participants were included and analyzed: 83 (50.3%) in the MyCourse group and 82 (49.7%) in the control group. In the intervention group, participants had access to a newly developed, digital, minimally guided SC intervention (MyCourse-Quit Smoking). Control group participants received a noninteractive web-based information brochure on SC. Both groups received unrestricted access to usual care. The primary outcome was self-reported 7-day smoking abstinence at the 6-month follow-up. Secondary outcomes were quality-adjusted life years gained, number of cigarettes smoked, nicotine dependence, and treatment satisfaction. For the health economic evaluation, intervention costs, health care costs, and costs stemming from productivity losses were assessed over a 12-month horizon. RESULTS: At the 6-month follow-up, the quit rates were 28% (23/83) and 26% (21/82) in the MyCourse and control groups, respectively (odds ratio 0.47, 95% CI 0.03-7.86; P=.60). In both groups, nicotine dependence scores were reduced at 12 months, and the number of smoked cigarettes was reduced by approximately half. The number of cigarettes decreased more over time, and the MyCourse group demonstrated a significantly greater reduction at the 12-month follow-up (incidence rate ratio 0.87; 95% CI 0.76-1.00; P=.04). Intervention costs were estimated at US $193 per participant for the MyCourse group and US $74 for the control group. The mean per-participant societal costs were US $25,329 (SD US $29,137) and US $21,836 (SD US $25,792), respectively. In the cost-utility analysis, MyCourse was not preferred over the control group from a societal perspective. With smoking behavior as the outcome, the MyCourse group led to marginally better results per reduced pack-year against higher societal costs, with a mean incremental cost-effectiveness ratio of US $52,067 (95% CI US $32,515-US $81,346). CONCLUSIONS: At 6 months, there was no evidence of a differential effect on cessation rates; in both groups, approximately a quarter of the cancer survivors quit smoking and their number of cigarettes smoked was reduced by half. At 12 months, the MyCourse intervention led to a greater reduction in the number of smoked cigarettes, albeit at higher costs than for the control group. No evidence was found for a differential effect on quality-adjusted life years. TRIAL REGISTRATION: The Netherlands Trial Register NTR6011; https://www.trialregister.nl/trial/5434. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12885-018-4206-z.

Cancer survivors' views on digital support for smoking cessation and alcohol moderation: a survey and qualitative study.

BACKGROUND: Digital interventions may provide low-threshold support for smoking cessation (SC) and alcohol moderation (AM) to the growing population of cancer survivors. The objective was to explore preconditions of successful AM and SC digital interventions for cancer survivors. METHODS: Using a multi-method approach we conducted a survey (n = 240), a qualitative study consisting of four focus groups (n = 15) and semi-structured interviews with Dutch cancer survivors (n = 8). To help interpretation of our results we interviewed experts in the field of eHealth and cancer survivors (n = 6) and we organized an expert meeting (n = 7). Qualitative data were analysed using the Framework approach and were double-coded by two coders. RESULTS: Survey results show the majority of drinkers had not previously considered AM (n = 158, 84.9%), often because they deemed their alcohol use to be non-problematic. All current smokers in the survey had considered SC before. In focus groups and interviews it became clear that SC efforts did not always stem from their own willingness to quit smoking, but originated from a wish to please their social environment. Main themes to be addressed in digital SC and AM that emerged from the interviews and focus groups, centred on the different ways of identification as cancer survivors, need for autonomy, differential beliefs about SC and AM, and the importance of a positive, non-patronizing tone-of-voice. Several specific preferences for digital interventions were formulated, although some cancer survivors prefer no support or face-to-face contact. CONCLUSIONS: Cancer survivors are a diverse group with diverse preferences for AM and SC support. Digital AM and SC interventions for cancer survivors are perceived to be of value by some, especially when they incorporate a positive, non-judgemental and non-patronizing tone-of-voice, address concerns specifically relevant to cancer survivors, offer possibilities for personalization, and emphasize autonomy throughout. To encourage AM specifically, problem recognition and awareness of the health benefits of AM should be improved.

The effectiveness of distance-based interventions for smoking cessation and alcohol moderation among cancer survivors: A meta-analysis.

OBJECTIVE: The objective of this study is to evaluate current evidence for the effectiveness of distance-based interventions to support smoking cessation (SC) or alcohol moderation (AM) among cancer survivors. Secondary, differences in effectiveness are explored regarding multibehaviour interventions versus single-behaviour interventions targeting SC or AM only. METHODS: A systematic search of PubMed, PsycINFO, Web of Science, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials was conducted. Intervention studies with and without control groups and randomized controlled trials were included. Random effects meta-analyses were conducted for the main outcomes: SC and AM rates at the follow-up closest to 6 months. Using subgroup analyses and meta-regression, effectiveness of single-behaviour versus multibehaviour interventions was evaluated. RESULTS: A total of 17 studies with 3796 participants; nine studies on SC only, eight studies on multibehaviour interventions including an SC or AM module, and no studies on AM only were included. All studies had at least some concerns regarding bias. Distance-based SC interventions led to higher cessation rates than control conditions (10 studies, odds ratio [OR] = 1.56; 95% CI, 1.13-2.15, P = .007). Single-behaviour SC interventions reduced smoking rates compared with baseline (risk difference [RD] = 0.29; 95% CI, 0.19-0.39, P < .0001), but multibehaviour interventions did not (RD = 0.13; 95% CI, -0.05 to 0.31, P = 0.15). There was insufficient evidence that distance-based multibehaviour interventions reduced alcohol use compared with controls (three studies, standardized mean difference [SMD] = 0.12; 95% CI, -0.08 to 0.31, P = .24). CONCLUSIONS: Distance-based SC interventions are effective in supporting SC among cancer survivors. Single-behaviour SC interventions appear more effective than multibehaviour interventions. No evidence was found for the effectiveness of distance-based AM interventions for cancer survivors.

Effectiveness and treatment moderators of internet interventions for adult problem drinking: An individual patient data meta-analysis of 19 randomised controlled trials.

BACKGROUND: Face-to-face brief interventions for problem drinking are effective, but they have found limited implementation in routine care and the community. Internet-based interventions could overcome this treatment gap. We investigated effectiveness and moderators of treatment outcomes in internet-based interventions for adult problem drinking (iAIs). METHODS AND FINDINGS: Systematic searches were performed in medical and psychological databases to 31 December 2016. A one-stage individual patient data meta-analysis (IPDMA) was conducted with a linear mixed model complete-case approach, using baseline and first follow-up data. The primary outcome measure was mean weekly alcohol consumption in standard units (SUs, 10 grams of ethanol). Secondary outcome was treatment response (TR), defined as less than 14/21 SUs for women/men weekly. Putative participant, intervention, and study moderators were included. Robustness was verified in three sensitivity analyses: a two-stage IPDMA, a one-stage IPDMA using multiple imputation, and a missing-not-at-random (MNAR) analysis. We obtained baseline data for 14,198 adult participants (19 randomised controlled trials [RCTs], mean age 40.7 [SD = 13.2], 47.6% women). Their baseline mean weekly alcohol consumption was 38.1 SUs (SD = 26.9). Most were regular problem drinkers (80.1%, SUs 44.7, SD = 26.4) and 19.9% (SUs 11.9, SD = 4.1) were binge-only drinkers. About one third were heavy drinkers, meaning that women/men consumed, respectively, more than 35/50 SUs of alcohol at baseline (34.2%, SUs 65.9, SD = 27.1). Post-intervention data were available for 8,095 participants. Compared with controls, iAI participants showed a greater mean weekly decrease at follow-up of 5.02 SUs (95% CI -7.57 to -2.48, p < 0.001) and a higher rate of TR (odds ratio [OR] 2.20, 95% CI 1.63-2.95, p < 0.001, number needed to treat [NNT] = 4.15, 95% CI 3.06-6.62). Persons above age 55 showed higher TR than their younger counterparts (OR = 1.66, 95% CI 1.21-2.27, p = 0.002). Drinking profiles were not significantly associated with treatment outcomes. Human-supported interventions were superior to fully automated ones on both outcome measures (comparative reduction: -6.78 SUs, 95% CI -12.11 to -1.45, p = 0.013; TR: OR = 2.23, 95% CI 1.22-4.08, p = 0.009). Participants treated in iAIs based on personalised normative feedback (PNF) alone were significantly less likely to sustain low-risk drinking at follow-up than those in iAIs based on integrated therapeutic principles (OR = 0.52, 95% CI 0.29-0.93, p = 0.029). The use of waitlist control in RCTs was associated with significantly better treatment outcomes than the use of other types of control (comparative reduction: -9.27 SUs, 95% CI -13.97 to -4.57, p < 0.001; TR: OR = 3.74, 95% CI 2.13-6.53, p < 0.001). The overall quality of the RCTs was high; a major limitation included high study dropout (43%). Sensitivity analyses confirmed the robustness of our primary analyses. CONCLUSION: To our knowledge, this is the first IPDMA on internet-based interventions that has shown them to be effective in curbing various patterns of adult problem drinking in both community and healthcare settings. Waitlist control may be conducive to inflation of treatment outcomes.

Internet-based self-help smoking cessation and alcohol moderation interventions for cancer survivors: a study protocol of two RCTs.

BACKGROUND: Brief interventions for smoking cessation and alcohol moderation may contribute considerably to the prevention of cancer among populations at risk, such as cancer survivors, in addition to improving their general wellbeing. There is accumulating evidence for the effectiveness of internet-based brief health behaviour interventions. The objective of this study is to assess the effectiveness, patient-level cost-effectiveness and cost-utility of two new online theory-based self-help interventions among adult cancer survivors in the Netherlands. One of the interventions focuses on alcohol moderation, the other on smoking cessation. Both interventions are tailored to cancer survivors. METHODS: Effectiveness will be assessed in two separate, nearly identical 2-armed RCTs: alcohol moderation (AM RCT) and smoking cessation (SC RCT). Participants are randomly allocated to either the intervention groups or the control groups. In the intervention groups, participants have access to one of the newly developed interventions. In the control groups, participants receive an online static information brochure on alcohol (AM RCT) or smoking (SC RCT). Main study outcome parameters are the number of drinks post-randomisation (AM RCT) and tobacco abstinence (SC RCT). In addition, cost-data and possible effect moderators and mediators will be assessed. Both treatments are internet-based minimally guided self-help interventions: MyCourse - Moderate Drinking (in Dutch: MijnKoers - Minderen met Drinken) and MyCourse - Quit Smoking (MijnKoers - Stoppen met Roken). They are based on cognitive behaviour therapy (CBT), motivational interviewing (MI) and acceptance and commitment therapy (ACT). Both interventions are optimized in collaboration with the target population of cancer survivors in focus groups and interviews, and in collaboration with several experts on eHealth, smoking cessation, alcohol misuse and cancer survivorship. DISCUSSION: The present study will add to scientific knowledge on the (cost-)effectiveness of internet-based self-help interventions to aid in smoking cessation or alcohol moderation, working mechanisms and impact on quality of life of cancer survivors. If found effective, these interventions can contribute to providing evidence-based psychosocial oncology care to a growing population of cancer survivors. TRIAL REGISTRATION: Trials are prospectively registered in The Netherlands Trial Register (NTR): NTR6011 (SC RCT), NTR6010 (AM RCT) on 1 September 2016.

Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions.

BACKGROUND: Prevention of depression is important due to the substantial burden of disease associated with it. To this end, we developed a novel, brief, and low-threshold Web-based self-help approach for depressive complaints called complaint-directed mini-interventions (CDMIs). These CDMIs focus on highly prevalent complaints that are demonstrably associated with depression and have a substantial economic impact: stress, sleep problems, and worry. OBJECTIVE: The aim was to evaluate the effectiveness of the Web-based self-help CDMIs in a sample of adults with mild-to-moderate depressive symptoms compared to a wait-list control group. METHODS: A two-armed randomized controlled trial was conducted. An open recruitment strategy was used. Participants were randomized to either the Web-based CDMIs or the no-intervention wait-list control group. The CDMIs are online, unguided, self-help interventions, largely based on cognitive behavioral techniques, which consist of 3 to 4 modules with up to 6 exercises per module. Participants are free to choose between the modules and exercises. Assessments, using self-report questionnaires, took place at baseline and at 3 and 6 months after baseline. The control group was given access to the intervention following the 3-month assessment. The primary goal of the CDMIs is to reduce depressive complaints. The primary outcome of the study was a reduction in depressive complaints as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Secondary outcomes included reductions in stress, worry, sleep problems, and anxiety complaints, and improvements in well-being. Data were analyzed using linear mixed models. RESULTS: In total, 329 participants enrolled in the trial, of which 165 were randomized to the intervention group and 164 to the control group. Approximately three-quarters of the intervention group actually created an account. Of these participants, 91.3% (116/127) logged into their chosen CDMI at least once during the 3-month intervention period (median 3, range 0-166). After 3 months, there was a significant reduction in depressive symptomatology for participants in the intervention group compared to participants in the wait-list control group (reduction in depression: mean -4.47, 95% CI -6.54 to -2.40; Cohen d=-0.70). Furthermore, significant effects were observed for sleep problems, worry, anxiety, and well-being, with effect sizes ranging from -0.29 to -0.40. The intervention did not significantly reduce stress. At 6-month follow-up, the improvements in the intervention group were generally sustained. CONCLUSIONS: This study shows that the online self-help CDMIs have a positive impact on various mental health outcomes. Future research should focus on which specific strategies may boost adherence, and increase the reach of the CDMIs among people with low socioeconomic status. CLINICALTRIAL: Netherlands Trial Register (NTR): NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM).

Drinker prototype alteration and cue reminders as strategies in a tailored web-based intervention reducing adults' alcohol consumption: randomized controlled trial.

BACKGROUND: Excessive alcohol use is a prevalent and worldwide problem. Excessive drinking causes a significant burden of disease and is associated with both morbidity and excess mortality. Prototype alteration and provision of a cue reminder could be useful strategies to enhance the effectiveness of online tailored interventions for excessive drinking. OBJECTIVE: Through a Web-based randomized controlled trial, 2 strategies (ie, prototype alteration and cue reminders) within an existing online personalized feedback intervention (Drinktest) aimed to reduce adults' excessive drinking. It was expected that both strategies would add to Drinktest and would result in reductions in alcohol consumption by intrinsic motivation and the seizure of opportunities to act. METHODS: Participants were recruited online and through printed materials. Excessive drinking adults (N=2634) were randomly assigned to 4 conditions: original Drinktest, Drinktest plus prototype alteration, Drinktest plus cue reminder, and Drinktest plus prototype alteration and cue reminder. Evaluation took place at 1-month posttest and 6-month follow-up. Differences in drinking behavior, intentions, and behavioral willingness (ie, primary outcomes) were assessed by means of longitudinal multilevel analyses using a last observation carried forward method. Measures were based on self-reports. RESULTS: All conditions showed reductions in drinking behavior and willingness to drink, and increased intentions to reduce drinking. Prototype alteration (B=-0.15, P<.05) and cue reminder usage (B=-0.15, P<.05) were both more effective in reducing alcohol consumption than when these strategies were not provided. Combining the strategies did not produce a synergistic effect. No differences across conditions were found regarding intentions or willingness. CONCLUSIONS: Although individuals' awareness of their cue was reasonable, their reported alcohol consumption was nevertheless reduced. Individuals appeared to distance their self-image from heavier drinking prototypes. Thus, prototype alteration and cue reminder usage may be feasible and simple intervention strategies to promote reductions in alcohol consumption among adults, with an effect up to 6 months. TRIAL REGISTRATION: Nederlands Trial Register (NTR): 4169; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4169 (Archived by WebCite at http://www.webcitation.org/6VD2jnxmB).

Digital Smoking Cessation Intervention for Cancer Survivors: Analysis of Predictors and Moderators of Engagement and Outcome Alongside a Randomized Controlled Trial.

BACKGROUND: Recent studies have shown positive, though small, clinical effects of digital smoking cessation (SC) interventions for cancer survivors. However, research on associations among participant characteristics, intervention engagement, and outcomes is limited. OBJECTIVE: This study aimed to explore the predictors and moderators of engagement and outcome of MyCourse-Quit Smoking (in Dutch: "MijnKoers-Stoppen met Roken"), a digital minimally guided intervention for cancer survivors. METHODS: A secondary analysis of data from the randomized controlled trial was performed. The number of cigarettes smoked in the past 7 days at 6-month follow-up was the primary outcome measure. We analyzed interactions among participant characteristics (11 variables), intervention engagement (3 variables), and outcome using robust linear (mixed) modeling. RESULTS: In total, 165 participants were included in this study. Female participants accessed the intervention less often than male participants (B=-11.12; P=.004). A higher Alcohol Use Disorders Identification Test score at baseline was associated with a significantly higher number of logins (B=1.10; P<.001) and diary registrations (B=1.29; P<.001). A higher Fagerström Test for Nicotine Dependence score at baseline in the intervention group was associated with a significantly larger reduction in tobacco use after 6 months (B=-9.86; P=.002). No other associations and no moderating effects were found. CONCLUSIONS: Overall, a limited number of associations was found between participant characteristics, engagement, and outcome, except for gender, problematic alcohol use, and nicotine dependence. Future studies are needed to shed light on how this knowledge can be used to improve the effects of digital SC programs for cancer survivors. TRIAL REGISTRATION: Netherlands Trial register NTR6011/NL5434; https://onderzoekmetmensen.nl/nl/trial/22832.

Action Opportunities to Pursue Responsible Digital Care for People With Intellectual Disabilities: Qualitative Study.

BACKGROUND: Responsible digital care refers to any intentional systematic effort designed to increase the likelihood of a digital care technology developed through ethical decision-making, being socially responsible and aligned with the values and well-being of those impacted by it. OBJECTIVE: We aimed to present examples of action opportunities for (1) designing "technology"; (2) shaping the "context" of use; and (3) adjusting the behavior of "users" to guide responsible digital care for people with intellectual disabilities. METHODS: Three cases were considered: (1) design of a web application to support the preparation of meals for groups of people with intellectual disabilities, (2) implementation of an app to help people with intellectual disabilities regulate their stress independently, and (3) implementation of a social robot to stimulate interaction and physical activity among people with intellectual disabilities. Overall, 26 stakeholders participated in 3 multistakeholder workshops (case 1: 10/26, 38%; case 2: 10/26, 38%; case 3: 6/26, 23%) based on the "guidance ethics approach." We identified stakeholders' values based on bottom-up exploration of experienced and expected effects of using the technology, and we formulated action opportunities for these values in the specific context of use. Qualitative data were analyzed thematically. RESULTS: Overall, 232 effects, 33 values, and 156 action opportunities were collected. General and case-specific themes were identified. Important stakeholder values included quality of care, autonomy, efficiency, health, enjoyment, reliability, and privacy. Both positive and negative effects could underlie stakeholders' values and influence the development of action opportunities. Action opportunities comprised the following: (1) technology: development of the technology (eg, user experience and customization), technology input (eg, recipes for meals, intervention options for reducing stress, and activities), and technology output (eg, storage and use of data); (2) context: guidelines, training and support, policy or agreements, and adjusting the physical environment in which the technology is used; and (3) users: integrating the technology into daily care practice, by diminishing (eg, "letting go" to increase the autonomy of people with intellectual disabilities), retaining (eg, face-to-face contact), and adding (eg, evaluation moments) certain behaviors of care professionals. CONCLUSIONS: This is the first study to provide insight into responsible digital care for people with intellectual disabilities by means of bottom-up exploration of action opportunities to take account of stakeholders' values in designing technology, shaping the context of use, and adjusting the behavior of users. Although part of the findings may be generalized, case-specific insights and a complementary top-down approach (eg, predefined ethical frameworks) are essential. The findings represent a part of an ethical discourse that requires follow-up to meet the dynamism of stakeholders' values and further develop and implement action opportunities to achieve socially desirable, ethically acceptable, and sustainable digital care that improves the lives of people with intellectual disabilities.

An Internet-based intervention to promote mental fitness for mildly depressed adults: randomized controlled trial.

BACKGROUND: Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. OBJECTIVE: Psyfit ("mental fitness online") is a fully automated self-help intervention to improve well-being based on positive psychology. This study examines the clinical effects of this intervention. METHODS: We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months (n=143) to a waiting-list control condition (n=141). Mild to moderately depressed adults in the general population seeking self-help were recruited. Primary outcome was well-being measured by Mental Health Continuum-Short Form (MHC-SF) and WHO Well-being Index (WHO-5); secondary outcomes were depressive symptoms, anxiety, vitality, and general health measured by Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and Medical Outcomes Study-Short Form (MOS-SF) vitality and general health subscales, respectively. Online measurements were taken at baseline, 2 months, and 6 months after baseline. RESULTS: The dropout rate was 37.8% in the Psyfit group and 22.7% in the control group. At 2-month follow-up, Psyfit tended to be more effective in enhancing well-being (nonsignificantly for MHC-SF: Cohen's d=0.27, P=.06; significantly for WHO-5: Cohen's d=0.31, P=.01), compared to the waiting-list control group. For the secondary outcomes, small but significant effects were found for general health (Cohen's d=0.14, P=.01), vitality (d=0.22, P=.02), anxiety symptoms (Cohen's d=0.32, P=.001), and depressive symptoms (Cohen's d=0.36, P=.02). At 6-month follow-up, there were no significant effects on well-being (MHC-SF: Cohen's d=0.01, P=.90; WHO-5: Cohen's d=0.26, P=.11), whereas depressive symptoms (Cohen's d=0.35, P=.02) and anxiety symptoms (Cohen's d=0.35, P=.001) were still significantly reduced compared to the control group. There was no clear dose-response relationship between adherence and effectiveness, although some significant differences appeared across most outcomes in favor of those completing at least 1 lesson in the intervention. CONCLUSIONS: This study shows that an online well-being intervention can effectively enhance well-being (at least in the short-term and for 1 well-being measure) and can help to reduce anxiety and depression symptoms. Further research should focus on increasing adherence and motivation, reaching and serving lower-educated people, and widening the target group to include people with different levels of depressive symptoms. TRIAL REGISTRATION: Netherlands Trial Register (NTR) number: NTR2126; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2126 (archived by WebCite at http://www.webcitation.org/6IIiVrLcO).

The impact of assistive living technology on perceived independence of people with a physical disability in executing daily activities: a systematic literature review.

PURPOSE: People with physical disabilities often require lifetime support and experience challenges to maintain or (re)define their level of independence. Assistive living technologies (ALT) are promising to increase independent living and execution of activities of daily living (ADL). This paper provides a systematic literature review that aims to analyse the present state of the literature about the impact of ALT on perceived independence of people with a physical disability receiving long-term care. MATERIALS AND METHODS: Databases Embase, Medline, and Web of Science were searched for eligible studies from 2010 or later. RESULTS: Nine studies were included, of which seven qualitative, one quantitative, and one mixed methods. Quality was generally high. ALT enabled participants to execute ADL. We found six themes for the impact of ALT on perceived independence: feeling enabled, choice and control, feeling secure, time alone, feeling less needy, and participation. CONCLUSIONS: ALT appears to impact perceived independence in many ways, exceeding merely the executional aspect of independence. Existing research is limited and quite one-sided. More large-scale studies are needed in order to inform care organisations how to implement ALT, especially considering societal developments and challenges impacting long-term care.IMPLICATIONS FOR REHABILITATIONPeople with a physical disability receiving long-term care experience that assistive living technology impacted their independence.Their independence is increased by making them feel enabled, secure, and less needy and increasing their choice and control, time alone, and participation.Most studies focused on the use of environmental control systems by people with spinal cord injury.More research is needed to evaluate long-term effects of diverse assistive living technologies used by people with a physical disability receiving long-term care.

Results from an online computer-tailored weight management intervention for overweight adults: randomized controlled trial.

BACKGROUND: Prevention of weight gain has been suggested as an important strategy in the prevention of obesity and people who are overweight are a specifically important group to target. Currently there is a lack of weight gain prevention interventions that can reach large numbers of people. Therefore, we developed an Internet-delivered, computer-tailored weight management intervention for overweight adults. The focus of the intervention was on making small (100 kcal per day), but sustained changes in dietary intake (DI) or physical activity (PA) behaviors in order to maintain current weight or achieve modest weight loss. Self-regulation theory was used as the basis of the intervention. OBJECTIVE: This study aims to evaluate the efficacy of the computer-tailored intervention in weight-related anthropometric measures (Body Mass Index, skin folds and waist circumference) and energy balance-related behaviors (physical activity; intake of fat, snacks and sweetened drinks) in a randomized controlled trial. METHODS: The tailored intervention (TI) was compared to a generic information website (GI). Participants were 539 overweight adults (mean age 47.8 years, mean Body Mass Index (BMI) 28.04, 30.9% male, 10.7% low educated) who where recruited among the general population and among employees from large companies by means of advertisements and flyers. Anthropometric measurements were measured by trained research assistants at baseline and 6-months post-intervention. DI and PA behaviors were assessed at baseline, 1-month and 6-month post-intervention, using self-reported questionnaires. RESULTS: Repeated measurement analyses showed that BMI remained stable over time and that there were no statistically significant differences between the study groups (BMI: TI=28.09, GI=27.61, P=.09). Similar results were found for waist circumference and skin fold thickness. Amount of physical activity increased and intake of fat, snacks and sweetened drinks decreased during the course of the study, but there were no differences between the study groups (eg, fat intake: TI=15.4, GI=15.9, P=.74). The first module of the tailored intervention was visited by almost all participants, but only 15% completed all four modules of the tailored intervention, while 46% completed the three modules of the general information intervention. The tailored intervention was considered more personally relevant (TI=3.20, GI=2.83, P=.001), containing more new information (TI=3.11, GI=2.73, P=.003) and having longer texts (TI=3.20, GI=3.07, P=.01), while there were no group differences on other process measures such as attractiveness and comprehensibility of the information (eg, attractive design: TI=3.22, GI=3.16, P=.58). CONCLUSIONS: The online, computer-tailored weight management intervention resulted in changes in the desired direction, such as stabilization of weight and improvements in dietary intake, but the intervention was not more effective in preventing weight gain or modifying dietary and physical activity behaviors than generic information. A possible reason for the absence of intervention effects is sub-optimal use of the intervention and the self-regulation components. Further research is therefore needed to gain more insight into how the intervention and exposure to its contents can be improved. TRIAL REGISTRATION: NTR1862; http://apps.who.int/trialsearch/trial.aspx?trialid=NTR1862.

Experiences of Persons With Executive Dysfunction in Disability Care Using a Social Robot to Execute Daily Tasks and Increase the Feeling of Independence: Multiple-Case Study.

BACKGROUND: Executive functions are essential for independently navigating nearly all of our daily activities. Executive dysfunction often occurs as a result of a neurodevelopmental disorder. Persons with executive dysfunction experience challenges regarding independent execution of daily tasks. Social robots might support persons with executive dysfunction to execute daily tasks and promote their feeling of independence. OBJECTIVE: This study aimed to study the impact of interacting with social robot Tessa on goal attainment in the execution of daily tasks and perceived independence of persons with executive dysfunction. METHODS: In this multiple-case study, 18 participant-caregiver couples were followed up while using Tessa in the home environment for 3 months. Goal attainment on independently performing a self-determined goal was measured by the Goal Attainment Scale, and participant-caregiver couples were interviewed about their experience with their interaction with Tessa and how they perceived Tessa's impact on their independence. RESULTS: In total, 11 (61%) participants reached their goal after 6 weeks and maintained their goal after 3 months. During the study period, 2 participant-caregiver couples withdrew because of mismatch with Tessa. Participants set goals in the following domains: execution of household tasks; intake of food, water, or medication; being ready in time for an appointment; going to bed or getting out of bed on time; personal care; and exercise. Participants perceived that Tessa increased the feeling of independence by generating more structure, stimulation, and self-direction. Participant-caregiver couples reported that the auditive information provided by Tessa was more effective in coping with executive dysfunction compared to their initial approaches using visual information, and the use of Tessa had a positive impact on their relationship. CONCLUSIONS: This study paid ample time and attention to the implementation of a social robot in daily care practice. The encouraging findings support the use of social robot Tessa for the execution of daily tasks and increasing independence of persons with executive dysfunction in disability care.

Comparing a ses-sensitive and an all-ses implementation strategy to improve participation rates of patients with a lower socioeconomic background in a web-based intervention for depressive complaints: a cluster randomised trial in primary care.

BACKGROUND: Depression is a major public health concern, which is most pronounced in population segments with a lower social-economic status (SES). E-health interventions for depressive complaints are proven to be effective, but their reach needs to be improved, especially among people with a lower socioeconomic status (SES). Implementing e-health interventions in the primary care setting with SES-sensitive guidance from General Practice nurses (GP nurses) may be a useful strategy to increase the reach of e-health in lower SES groups. We implemented an evidence-based online intervention that targets depressive complaints in primary care. METHODS: A pragmatic cluster-randomised trial was conducted in two parallel groups where a SES sensitive (SES-sens) implementation strategy with additional face-to-face guidance by GP nurses was compared to an all-SES implementation strategy. The primary outcome was the percentage of lower SES participants in either condition. Participation was defined as completing at least 1 face-to-face session and 2 online exercises. Participation rates were evaluated using logistic mixed modelling. RESULTS: In both conditions, the participation rates of lower SES participants were quite high, but were notably lower in the SES-sens implementation condition (44%) than in the all-SES implementation condition (58%). This unexpected outcome remained statistically significant even after adjusting for potential confounders between the conditions (Odds Ratio 0.43, 95%-CI 0.22 to 0.81). Less guidance was provided by the GP nurses in the SES-sens group, contrary to the implementation instructions. CONCLUSIONS: From a public health point of view, it is good news that a substantial number of primary care patients with a lower SES level used the implemented e-health intervention. It is also positive that an all-SES implementation strategy performed well, and even outperformed a SES-sensitive strategy. However, this was an unexpected finding, warranting further research into tailoring implementation strategies of e-health interventions towards specific target groups in the primary care setting. TRIAL REGISTRATION: Netherlands Trial Register, identifier: NL6595 , registered on 12 November 2017.

Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation.

BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. OBJECTIVE: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. METHODS: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. RESULTS: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. CONCLUSIONS: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42555.

The reach of a hepatitis B vaccination programme among men who have sex with men.

BACKGROUND: Homosexual contact is a major risk factor for acute hepatitis B infection. This study explores how many and which men who have sex with men (MSM) are reached by the ongoing hepatitis B vaccination programme in The Netherlands (started in 2002), and investigate reasons for non-participation and non-compliance. METHODS: In this cross-sectional study, on the basis of ethnographic mapping and targeted sampling, 320 MSM were interviewed at different venues in three regions in The Netherlands. RESULTS: Of the sample, 74% reported to be aware of the opportunity to obtain free hepatitis B vaccination, and 50% reported to be vaccinated (received at least one injection). Compliance with the three-dose vaccination schedule was 84%. The most important reason for non-participation in the vaccination programme was a low perceived risk of getting infected with the virus. A personal approach by STD-prevention workers, the recruitment region and having sex with casual partners were positively associated with vaccination uptake. Being bisexual was negatively associated with, and visiting gay bars/discos was positively associated with, awareness of the opportunity to obtain free hepatitis B vaccination. CONCLUSION: This study shows a large proportion of MSM is aware that they could opt for free hepatitis B vaccination. Future vaccination programmes should focus on a personal approach, since the use of STD prevention workers was shown to be a successful tool for participation in the vaccination programme. The personal information should focus on perceived risk of infection, since this was a major reason for vaccine refusal.

Curbing alcohol use in male adults through computer generated personalized advice: randomized controlled trial.

BACKGROUND: In recent years, interventions that deliver online personalized feedback on alcohol use have been developed and appear to be a feasible way to curb heavy drinking. Randomized controlled trials (RCTs) among the general adult population, however, are scarce. The present study offers an RCT of Drinktest.nl, an online personalized feedback intervention in the Netherlands. OBJECTIVE: The aim of this study was to assess the effectiveness of computer-based personalized feedback on heavy alcohol use in male adults. METHODS: Randomization stratified by age and educational level was used to assign participants to either the intervention consisting of online personalized feedback or an information-only control condition. Participants were told as a cover story that they would evaluate newly developed health education materials. Participants were males (n = 450), aged 18 to 65 years, presenting with either heavy alcohol use (> 20 units of alcohol weekly) and/or binge drinking (> 5 units of alcohol at a single occasion at least 1 day per week) in the past 6 months. They were selected with a screener from a sampling frame of 25,000 households. The primary outcome measure was the percentage of the participants that had successfully reduced their drinking levels to below the Dutch guideline threshold for at-risk drinking. RESULTS: Intention-to-treat analysis showed that in the experimental condition, 42% (97/230) of the participants were successful in reducing their drinking levels to below the threshold at the 1-month follow-up as compared with 31% (67/220) in the control group (odds ratio [OR] = 1.7, number needed to treat [NNT] = 8.6), which was statistically significant (χ(2) (1) = 6.67, P = .01). At the 6-month follow-up, the success rates were 46% (105/230) and 37% (82/220) in the experimental and control conditions, respectively (OR = 1.4, NNT = 11.9), but no longer statistically significant (χ(2) (1) = 3.25, P = .07). CONCLUSIONS: Personalized online feedback on alcohol consumption appears to be an effective and easy way to change unhealthy drinking patterns in adult men, at least in the short-term.

Effectiveness of E-self-help interventions for curbing adult problem drinking: a meta-analysis.

BACKGROUND: Self-help interventions without professional contact to curb adult problem drinking in the community are increasingly being delivered via the Internet. OBJECTIVE: The objective of this meta-analysis was to assess the overall effectiveness of these eHealth interventions. METHODS: In all, 9 randomized controlled trials (RCTs), all from high-income countries, with 9 comparison conditions and a total of 1553 participants, were identified, and their combined effectiveness in reducing alcohol consumption was evaluated by means of a meta-analysis. RESULTS: An overall medium effect size (g = 0.44, 95% CI 0.17-0.71, random effect model) was found for the 9 studies, all of which compared no-contact interventions to control conditions. The medium effect was maintained (g = 0.39; 95% CI 0.23-0.57, random effect model) after exclusion of two outliers. Type of control group, treatment location, type of analysis, and sample size did not have differential impacts on treatment outcome. A significant difference (P = .04) emerged between single-session personalized normative feedback interventions (g = 0.27, 95% CI 0.11-0.43) and more extended e- self-help (g = 0.61, 95% CI 0.33-0.90). CONCLUSION: E-self-help interventions without professional contact are effective in curbing adult problem drinking in high-income countries. In view of the easy scalability and low dissemination costs of such interventions, we recommend exploration of whether these could broaden the scope of effective public health interventions in low- and middle-income countries as well.