Effects of Exergaming on Cognitive and Social Functioning of People with Dementia: A Randomized Controlled Trial.

OBJECTIVES: Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs). DESIGN: A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group. SETTING AND PARTICIPANTS: A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week. METHODS: All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD. SECONDARY OUTCOMES: physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences. RESULTS: Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P = .007; and Trail Making Test part A (TMT-A): r = -28.98, 95% CI: -54.89, -3.08, P = .029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = -1.86, 95% CI: -3.56, -0.17, P = .031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = -3.30, 95% CI: -6.57, -0.03, P = .048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P = .005). CONCLUSIONS AND IMPLICATIONS: Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation.

A Self-management Approach for Dietary Sodium Restriction in Patients With CKD: A Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Patients with chronic kidney disease (CKD) are particularly sensitive to dietary sodium. We evaluated a self-management approach for dietary sodium restriction in patients with CKD. STUDY DESIGN: Randomized controlled trial. SETTING & PARTICIPANTS: Nephrology outpatient clinics in 4 Dutch hospitals. 99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate≥25mL/min/1.73m2) kidney transplant, hypertension, and sodium intake>130mmol/d. INTERVENTION: Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching over a 6-month maintenance period. OUTCOMES: Primary outcomes were sodium excretion after the 3-month intervention and after the 6-month maintenance period. Secondary outcomes were blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation. RESULTS: Baseline estimated glomerular filtration rate was 55.0±22.0mL/min/1.73m2. During the intervention period, sodium excretion decreased in the intervention group from 188±8 (SE) to 148±8mmol/d (P<0.001), but did not change significantly in the control group. At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049). At 3 months, systolic blood pressure (SBP) decreased in the intervention group from 140±3 to 132±3mm Hg (P<0.001), but was unchanged in the control group. Mean difference in SBP across groups was-4.7 (95% CI, -10.7 to 1.3) mm Hg (P=0.1). During the maintenance phase, sodium excretion increased in the intervention group, but remained lower than at baseline at 160±8mmol/d (P=0.01), while it decreased in the control group from 174±9 at the end of the intervention period to 154±9mmol/d (P=0.001). Consequently, no difference in sodium excretion between groups was observed after the maintenance phase. There was no difference in SBP between groups after the maintenance phase. LIMITATIONS: Limited power, postrandomization loss to follow-up, Hawthorne effect, lack of dietary data, short-term follow-up. CONCLUSIONS: A coaching intervention reduced sodium intake at 3 months. Efficacy during the maintenance phase was diminished, possibly due to inadvertent adoption of the intervention by the control group. FUNDING: Grant funding from the Netherlands Organization for Health Research and Development and the Dutch Kidney Foundation. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02132013.

Implementation barriers and facilitators of an integrated multidisciplinary lifestyle enhancing treatment for inpatients with severe mental illness: the MULTI study IV.

BACKGROUND: Despite an increase in studies showing the efficacy of lifestyle interventions in improving the poor health outcomes for people with severe mental illness (SMI), routine implementation remains ad hoc. Recently, a multidisciplinary lifestyle enhancing treatment for inpatients with SMI (MULTI) was implemented as part of routine care at a long-term inpatient facility in the Netherlands, resulting in significant health improvements after 18 months. The current study aimed to identify barriers and facilitators of its implementation. METHODS: Determinants associated with the implementation of MULTI, related to the innovation, the users (patients, the healthcare professionals (HCPs)), and the organisational context, were assessed at the three wards that delivered MULTI. The evidence-based Measurement Instrument for Determinants of Innovations was used to assess determinants (29 items), each measured through a 5-point Likert scale and additional open-ended questions. We considered determinants to which ≥20% of the HCPs or patients responded negatively ("totally disagree/disagree", score < 3) as barriers and to which ≥80% of HCPs or patients responded positively ("agree/totally agree", score > 3) as facilitators. We included responses to open-ended questions if the topic was mentioned by ≥2 HCPs or patients. In total 50 HCPs (online questionnaire) and 46 patients (semi-structured interview) were invited to participate in the study. RESULTS: Participating HCPs (n = 42) mentioned organisational factors as the strongest barriers (e.g. organisational changes and financial resources). Patients (n = 33) mentioned the complexity of participating in MULTI as the main barrier, which could partly be due to organisational factors (e.g. lack of time for nurses to improve tailoring). The implementation was facilitated by positive attitudes of HCPs and patients towards MULTI, including their own role in it. Open responses of HCPs and patients showed strong commitment, collaboration and ownership towards MULTI. CONCLUSIONS: This is the first study analysing the implementation of a pragmatic lifestyle intervention targeting SMI inpatients in routine clinical care. Positive attitudes of both HCPs and patients towards such an approach facilitated the implementation of MULTI. We suggest that strategies addressing organisational implementation barriers are needed to further improve and maintain MULTI, to succeed in achieving positive health-related outcomes in inpatients with SMI.

The (cost-) effectiveness of exergaming in people living with dementia and their informal caregivers: protocol for a randomized controlled trial.

BACKGROUND: Physical activity is linked to benefits such as increased physical fitness, cognition, emotional and social functioning, general health and well-being in older people. Some evidence suggests that this also applies to people living with dementia. However, it can be harder for them to perform physical activities, due to several barriers, such as issues with orientation and balance problems. A relatively new type of physical activity called exergaming may help them overcome these barriers. Exergaming is "physical exercise interactively combined with cognitive stimulation in a gaming environment". The aim of our study is to evaluate the effectiveness and cost-effectiveness of exergaming compared to regular activities in people living with dementia, who attend day-care centres. Additionally, we want to investigate whether the exergaming activity for the person living with dementia, also (indirectly) affects the informal caregiver, as well as which facilitators and barriers to implementation of exergames for this target group exist. METHODS: A cluster Randomized Controlled Trial (RCT), with economic and process evaluations alongside will be carried out. In the Netherlands, 24 day-care centres are randomized in the experimental or control group. The study group will consist of 224 dyads (community-dwelling participants with dementia and their informal caregivers), who are interviewed at baseline, and at 3 and 6 months of follow-up. The participant with dementia has to visit the day-care centre for at least two days per week, have a diagnosis of mild to moderate dementia and have an informal caregiver present, who is willing to participate. Societal cost data will be collected during interviews, using healthcare utilization diaries, and from day-care centres. The process evaluation will only involve the experimental group, and will include an online survey, qualitative interviews and focus groups. DISCUSSION: This study will contribute to the evidence base that more effective exercise among people with dementia will result in positive effects on their wellbeing and quality of life. This will motivate people with dementia to be physically active. We also envision that there might be a positive effect on the burden of care experienced by their informal caregivers. TRIAL REGISTRATION: This trial was registered at the Netherlands Trial Register (NTR) on December 10, 2015 (number: NTR5537 ), this publication is based on protocol amendment number 01, issue date 28 December 2018. This includes all items from the World Health Organization Trial Registration Data Set [see Additional file 1].

Friendship with a robot: Children's perception of similarity between a robot's physical and virtual embodiment that supports diabetes self-management.

OBJECTIVE: The PAL project develops a conversational agent with a physical (robot) and virtual (avatar) embodiment to support diabetes self-management of children ubiquitously. This paper assesses 1) the effect of perceived similarity between robot and avatar on children's' friendship towards the avatar, and 2) the effect of this friendship on usability of a self-management application containing the avatar (a) and children's motivation to play with it (b). METHODS: During a four-day diabetes camp in the Netherlands, 21 children participated in interactions with both agent embodiments. Questionnaires measured perceived similarity, friendship, motivation to play with the app and its usability. RESULTS: Children felt stronger friendship towards the physical robot than towards the avatar. The more children perceived the robot and its avatar as the same agency, the stronger their friendship with the avatar was. The stronger their friendship with the avatar, the more they were motivated to play with the app and the higher the app scored on usability. CONCLUSION: The combination of physical and virtual embodiments seems to provide a unique opportunity for building ubiquitous long-term child-agent friendships. PRACTICE IMPLICATIONS: an avatar complementing a physical robot in health care could increase children's motivation and adherence to use self-management support systems.

Using a robot to personalise health education for children with diabetes type 1: a pilot study.

OBJECTIVE: Assess the effects of personalised robot behaviours on the enjoyment and motivation of children (8-12) with diabetes, and on their acquisition of health knowledge, in educational play. METHODS: Children (N=5) played diabetes quizzes against a personal or neutral robot on three occasions: once at the clinic, twice at home. The personal robot asked them about their names, sports and favourite colours, referred to these data during the interaction, and engaged in small talk. Fun, motivation and diabetes knowledge was measured. Child-robot interaction was observed. RESULTS: Children said the robot and quiz were fun, but this appreciation declined over time. With the personal robot, the children looked more at the robot and spoke more. The children mimicked the robot. Finally, an increase in knowledge about diabetes was observed. CONCLUSION: The study provides strong indication for how a personal robot can help children to improve health literacy in an enjoyable way. Children mimic the robot. When the robot is personal, they follow suit. Our results are positive and establish a good foundation for further development and testing in a larger study. PRACTICE IMPLICATIONS: Using a robot in health care could contribute to self-management in children and help them to cope with their illness.

Validity and Reliability of the eHealth Analysis and Steering Instrument.

BACKGROUND: eHealth services can contribute to individuals' self-management, that is, performing lifestyle-related activities and decision making, to maintain a good health, or to mitigate the effect of an (chronic) illness on their health. But how effective are these services? Conducting a randomized controlled trial (RCT) is the golden standard to answer such a question, but takes extensive time and effort. The eHealth Analysis and Steering Instrument (eASI) offers a quick, but not dirty alternative. The eASI surveys how eHealth services score on 3 dimensions (ie, utility, usability, and content) and 12 underlying categories (ie, insight in health condition, self-management decision making, performance of self-management, involving the social environment, interaction, personalization, persuasion, description of health issue, factors of influence, goal of eHealth service, implementation, and evidence). However, there are no data on its validity and reliability. OBJECTIVE: The objective of our study was to assess the construct and predictive validity and interrater reliability of the eASI. METHODS: We found 16 eHealth services supporting self-management published in the literature, whose effectiveness was evaluated in an RCT and the service itself was available for rating. Participants (N=16) rated these services with the eASI. We analyzed the correlation of eASI items with the underlying three dimensions (construct validity), the correlation between the eASI score and the eHealth services' effect size observed in the RCT (predictive validity), and the interrater agreement. RESULTS: Three items did not fit with the other items and dimensions and were removed from the eASI; 4 items were replaced from the utility to the content dimension. The interrater reliabilities of the dimensions and the total score were moderate (total, κ=.53, and content, κ=.55) and substantial (utility, κ=.69, and usability, κ=.63). The adjusted eASI explained variance in the eHealth services' effect sizes (R(2) =.31, P<.001), as did the dimensions utility (R(2) =.49, P<.001) and usability (R(2) =.18, P=.021). Usability explained variance in the effect size on health outcomes (R(2) =.13, P=.028). CONCLUSIONS: After removing 3 items and replacing 4 items to another dimension, the eASI (3 dimensions, 11 categories, and 32 items) has a good construct validity and predictive validity. The eASI scales are moderately to highly reliable. Accordingly, the eASI can predict how effective an eHealth service is in regard to supporting self-management. Due to a small pool of available eHealth services, it is advised to reevaluate the eASI in the future with more services.

An online lifestyle diary with a persuasive computer assistant providing feedback on self-management.

In accordance with the global trend, in The Netherlands approximately 45% of the population is overweight. Existing studies show that patient self-management can reduce these figures, but medical non-adherence is a persistent problem. eHealth can potentially increase adherence to self-management. Consequently, we designed a persuasive computer assistant and evaluated its influence on self-management, i.e., the use of an online lifestyle diary called DieetInzicht.nl. The assistant is represented by an animated iCat, which shows different facial expressions and provides cooperative feedback following principles from the motivational interviewing method. We conducted a randomized controlled trial with 118 overweight people over a period of four weeks and studied the difference between diary use with and without computer assistant feedback. Results show that the computer assistant contributed to filling in the diary more frequently, reduced the decline in motivation to perform self-management, lowered the (reported) BMI, and improved the ease of use. Furthermore, diary use increased knowledge of maintaining a healthy lifestyle. Finally, personal characteristics, i.e., locus of control, vocabulary, computer experience, age, gender, education level and initial BMI, explained the variance in the diary use and its outcome. Of the 118 participants 35 filled in the closing survey, covering motivation, BMI, lifestyle knowledge and ease of use, which implies that the findings based on these results are mainly representative for motivated participants. In general, this study shows that the Dieetinzicht eHealth service, including a personal computer assistant, is likely to support motivated overweight people and lifestyle related diseases to get a better insight in and adhere to their self-management.