Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial.

OBJECTIVE: Medication for opioid use disorder (MOUD) improves treatment retention and reduces illicit opioid use. A-CHESS is an evidence-based smartphone intervention shown to improve addiction-related behaviors. The authors tested the efficacy of MOUD alone versus MOUD plus A-CHESS to determine whether the combination further improved outcomes. METHODS: In an unblinded parallel-group randomized controlled trial, 414 participants recruited from outpatient programs were assigned in a 1:1 ratio to receive either MOUD alone or MOUD+A-CHESS for 16 months and were followed for an additional 8 months. All participants were on methadone, buprenorphine, or injectable naltrexone. The primary outcome was abstinence from illicit opioid use; secondary outcomes were treatment retention, health services use, other substance use, and quality of life; moderators were MOUD type, gender, withdrawal symptom severity, pain severity, and loneliness. Data sources were surveys comprising multiple validated scales, as well as urine screens, every 4 months. RESULTS: There was no difference in abstinence between participants in the MOUD+A-CHESS and MOUD-alone arms across time (odds ratio=1.10, 95% CI=0.90-1.33). However, abstinence was moderated by withdrawal symptom severity (odds ratio=0.95, 95% CI=0.91-1.00) and MOUD type (odds ratio=0.57, 95% CI=0.34-0.97). Among participants without withdrawal symptoms, abstinence rates were higher over time for those in the MOUD+A-CHESS arm than for those in the MOUD-alone arm (odds ratio=1.30, 95% CI=1.01-1.67). Among participants taking methadone, those in the MOUD+A-CHESS arm were more likely to be abstinent over time (b=0.28, SE=0.09) than those in the MOUD-alone arm (b=0.06, SE=0.08), although the two groups did not differ significantly from each other (∆b=0.22, SE=0.11). MOUD+A-CHESS was also associated with greater meeting attendance (odds ratio=1.25, 95% CI=1.05-1.49) and decreased emergency department and urgent care use (odds ratio=0.88, 95% CI=0.78-0.99). CONCLUSIONS: Overall, MOUD+A-CHESS did not improve abstinence relative to MOUD alone. However, MOUD+A-CHESS may provide benefits for subsets of patients and may impact treatment utilization.

Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial.

BACKGROUND: Voice-controlled smart speakers and displays have a unique but unproven potential for delivering eHealth interventions. Many laptop- and smartphone-based interventions have been shown to improve multiple outcomes, but voice-controlled platforms have not been tested in large-scale rigorous trials. Older adults with multiple chronic health conditions, who need tools to help with their daily management, may be especially good candidates for interventions on voice-controlled devices because these patients often have physical limitations, such as tremors or vision problems, that make the use of laptops and smartphones challenging. OBJECTIVE: The aim of this study is to assess whether participants using an evidence-based intervention (ElderTree) on a smart display will experience decreased pain interference and improved quality of life and related measures in comparison with participants using ElderTree on a laptop and control participants who are given no device or access to ElderTree. METHODS: A total of 291 adults aged ≥60 years with chronic pain and ≥3 additional chronic conditions will be recruited from primary care clinics and community organizations and randomized 1:1:1 to ElderTree access on a smart display along with their usual care, ElderTree access on a touch screen laptop along with usual care, or usual care alone. All patients will be followed for 8 months. The primary outcomes are differences between groups in measures of pain interference and psychosocial quality of life. The secondary outcomes are between-group differences in system use at 8 months, physical quality of life, pain intensity, hospital readmissions, communication with medical providers, health distress, well-being, loneliness, and irritability. We will also examine mediators and moderators of the effects of ElderTree on both platforms. At baseline, 4 months, and 8 months, patients will complete written surveys comprising validated scales selected for good psychometric properties with similar populations. ElderTree use data will be collected continuously in system logs. We will use linear mixed-effects models to evaluate outcomes over time, with treatment condition and time acting as between-participant factors. Separate analyses will be conducted for each outcome. RESULTS: Recruitment began in August 2021 and will run through April 2023. The intervention period will end in December 2023. The findings will be disseminated via peer-reviewed publications. CONCLUSIONS: To our knowledge, this is the first study with a large sample and long time frame to examine whether a voice-controlled smart device can perform as well as or better than a laptop in implementing a health intervention for older patients with multiple chronic health conditions. As patients with multiple conditions are such a large cohort, the implications for cost as well as patient well-being are significant. Making the best use of current and developing technologies is a critical part of this effort. TRIAL REGISTRATION: ClinicalTrials.gov NCT04798196; https://clinicaltrials.gov/ct2/show/NCT04798196. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37522.

Effect of an eHealth intervention on older adults' quality of life and health-related outcomes: a randomized clinical trial.

BACKGROUND: By 2030, the number of US adults age ≥65 will exceed 70 million. Their quality of life has been declared a national priority by the US government. OBJECTIVE: Assess effects of an eHealth intervention for older adults on quality of life, independence, and related outcomes. DESIGN: Multi-site, 2-arm (1:1), non-blinded randomized clinical trial. Recruitment November 2013 to May 2015; data collection through November 2016. SETTING: Three Wisconsin communities (urban, suburban, and rural). PARTICIPANTS: Purposive community-based sample, 390 adults age ≥65 with health challenges. EXCLUSIONS: long-term care, inability to get out of bed/chair unassisted. INTERVENTION: Access (vs. no access) to interactive website (ElderTree) designed to improve quality of life, social connection, and independence. MEASURES: Primary outcome: quality of life (PROMIS Global Health). Secondary: independence (Instrumental Activities of Daily Living); social support (MOS Social Support); depression (Patient Health Questionnaire-8); falls prevention (Falls Behavioral Scale). Moderation: healthcare use (Medical Services Utilization). Both groups completed all measures at baseline, 6, and 12 months. RESULTS: Three hundred ten participants (79%) completed the 12-month survey. There were no main effects of ElderTree over time. Moderation analyses indicated that among participants with high primary care use, ElderTree (vs. control) led to better trajectories for mental quality of life (OR=0.32, 95% CI 0.10-0.54, P=0.005), social support received (OR=0.17, 95% CI 0.05-0.29, P=0.007), social support provided (OR=0.29, 95% CI 0.13-0.45, P<0.001), and depression (OR= -0.20, 95% CI -0.39 to -0.01, P=0.034). Supplemental analyses suggested ElderTree may be more effective among people with multiple (vs. 0 or 1) chronic conditions. LIMITATIONS: Once randomized, participants were not blind to the condition; self-reports may be subject to memory bias. CONCLUSION: Interventions like ET may help improve quality of life and socio-emotional outcomes among older adults with more illness burden. Our next study focuses on this population. TRIAL REGISTRATION: ClinicalTrials.gov ; registration ID number: NCT02128789.

A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial.

BACKGROUND: Multiple chronic conditions (MCCs) are common among older adults and expensive to manage. Two-thirds of Medicare beneficiaries have multiple conditions (eg, diabetes and osteoarthritis) and account for more than 90% of Medicare spending. Patients with MCCs also experience lower quality of life and worse medical and psychiatric outcomes than patients without MCCs. In primary care settings, where MCCs are generally treated, care often focuses on laboratory results and medication management, and not quality of life, due in part to time constraints. eHealth systems, which have been shown to improve multiple outcomes, may be able to fill the gap, supplementing primary care and improving these patients' lives. OBJECTIVE: This study aims to assess the effects of ElderTree (ET), an eHealth intervention for older adults with MCCs, on quality of life and related measures. METHODS: In this unblinded study, 346 adults aged 65 years and older with at least 3 of 5 targeted high-risk chronic conditions (hypertension, hyperlipidemia, diabetes, osteoarthritis, and BMI ≥30 kg/m2) were recruited from primary care clinics and randomized in a ratio of 1:1 to one of 2 conditions: usual care (UC) plus laptop computer, internet service, and ET or a control consisting of UC plus laptop and internet but no ET. Patients with ET have access for 12 months and will be followed up for an additional 6 months, for a total of 18 months. The primary outcomes of this study are the differences between the 2 groups with regard to measures of quality of life, psychological well-being, and loneliness. The secondary outcomes are between-group differences in laboratory scores, falls, symptom distress, medication adherence, and crisis and long-term health care use. We will also examine the mediators and moderators of the effects of ET. At baseline and months 6, 12, and 18, patients complete written surveys comprising validated scales selected for good psychometric properties with similar populations; laboratory data are collected from eHealth records; health care use and chronic conditions are collected from health records and patient surveys; and ET use data are collected continuously in system logs. We will use general linear models and linear mixed models to evaluate primary and secondary outcomes over time, with treatment condition as a between-subjects factor. Separate analyses will be conducted for outcomes that are noncontinuous or not correlated with other outcomes. RESULTS: Recruitment was conducted from January 2018 to December 2019, and 346 participants were recruited. The intervention period will end in June 2021. CONCLUSIONS: With self-management and motivational strategies, health tracking, educational tools, and peer community and support, ET may help improve outcomes for patients coping with ongoing, complex MCCs. In addition, it may relieve some stress on the primary care system, with potential cost implications. TRIAL REGISTRATION: ClinicalTrials.gov NCT03387735; https://www.clinicaltrials.gov/ct2/show/NCT03387735. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25175.

Using Smartphones to Improve Treatment Retention Among Impoverished Substance-Using Appalachian Women: A Naturalistic Study.

OBJECTIVES: Longer retention in treatment is associated with positive outcomes. For women, who suffer worse drug-related problems than men, social technologies, which are more readily adopted by women, may offer promise. This naturalistic study examined whether a smartphone-based relapse-prevention system, A-CHESS (Addiction-Comprehensive Health Enhancement Support System), could improve retention for women with substance use disorders in an impoverished rural setting. METHODS: A total of 98 women, age 18 to 40, in southeastern Kentucky and mandated to treatment, received A-CHESS with intensive outpatient treatment for 6 months. For comparison, data were obtained for a similar but non-equivalent group of 100 same-age women also mandated to treatment in the same clinics during the period. Electronic medical record data on length-of-stay and treatment service use for both groups were analyzed, with A-CHESS use data, to determine whether those using A-CHESS showed better retention than those without. RESULTS: Women with A-CHESS averaged 780 service units compared with 343 for the comparison group. For those with discharge dates prior to the study's end, A-CHESS patients stayed in treatment a mean of 410 vs 262 days for the comparison group. CONCLUSIONS: Given associations between retention and positive outcomes, mobile health technology such as A-CHESS may help improve outcomes among women, especially in settings where access to in-person services is difficult. The findings, based on a non-equivalent comparison, suggest the need for further exploration with rigorous experimental designs to determine whether and to what degree access to a smartphone with A-CHESS may extend and support recovery for women.

Pilot Test of a Computer-Based System to Help Family Caregivers of Dementia Patients.

BACKGROUND: Family members absorb much of the care of dementia patients. The burden of care substantially impacts caregivers' health, further straining our healthcare system. By 2050, the incidence of Alzheimer's disease will more than double, increasing the numbers of family caregivers proportionally. Interventions that reduce their burden are needed to preserve their health as well as the viability of the healthcare system. OBJECTIVE: This paper reports on the development and feasibility testing of a computer-based system intended to improve the lives of caregivers. D-CHESS (Dementia-Comprehensive Health Enhancement Support System) allows users to obtain information, communicate with other caregivers, get help with care decisions, and share information with experts. METHOD: Thirty-one caregivers were randomly assigned to an intervention group receiving D-CHESS for 6 months or to a control group receiving a caregiving book. Surveys at 0, 2, 4, and 6 months evaluated caregiver burden, family conflict, satisfaction with decisions, social support, loneliness, anxiety, depression, and coping competence. RESULTS: Survey findings suggest D-CHESS participants may perform better on measures of social support, anxiety, loneliness, and coping competence; the groups were equivalent on caregiver burden, decision satisfaction, and depression, and the control group reported less family conflict than the intervention. D-CHESS use data suggested enhancements to system design and content to increase awareness and use of various features. CONCLUSION: This study suggests that D-CHESS has potential to positively impact family caregivers and that the system merits further development and investigation with a full-scale clinical trial.