Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Gustafson DH

PROVIDER: S-EPMC7935655 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Gustafson David H DH Mares Marie-Louise ML Johnston Darcie C DC Mahoney Jane E JE Brown Randall T RT Landucci Gina G Pe-Romashko Klaren K Cody Olivia J OJ Gustafson David H DH Shah Dhavan V DV

JMIR research protocols 20210219 2

<h4>Background</h4>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 ...[more]

PMID: 33605887

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Project description:BACKGROUND:The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (? 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. METHODS/DESIGN:This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. DISCUSSION:This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action. TRIAL REGISTRATION:ClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.

Project description:BackgroundBy 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.ObjectiveAssess effects of an eHealth intervention for older adults on quality of life, independence, and related outcomes.DesignMulti-site, 2-arm (1:1), non-blinded randomized clinical trial. Recruitment November 2013 to May 2015; data collection through November 2016.SettingThree Wisconsin communities (urban, suburban, and rural).ParticipantsPurposive community-based sample, 390 adults age ≥65 with health challenges.Exclusionslong-term care, inability to get out of bed/chair unassisted.InterventionAccess (vs. no access) to interactive website (ElderTree) designed to improve quality of life, social connection, and independence.MeasuresPrimary 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.ResultsThree 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.LimitationsOnce randomized, participants were not blind to the condition; self-reports may be subject to memory bias.ConclusionInterventions 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 registrationClinicalTrials.gov ; registration ID number: NCT02128789.

Project description:BackgroundVoice-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.ObjectiveThe 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.MethodsA 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.ResultsRecruitment 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.ConclusionsTo 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 registrationClinicalTrials.gov NCT04798196; https://clinicaltrials.gov/ct2/show/NCT04798196.International registered report identifier (irrid)PRR1-10.2196/37522.

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Project description:PurposeOlder cancer survivors (≥ 65 years at diagnosis) are at high-risk for multimorbidity (2 + comorbid conditions). However, few studies have utilized a generalizable sample of older cancer survivors to understand how individual comorbid conditions, as opposed to total comorbidity burden, are associated with health-related quality of life (HRQOL). We examined associations between HRQOL outcomes (pain, fatigue, physical function), individual comorbidities (cardiovascular disease [CVD], lung disease, diabetes, arthritis) and total comorbidity (cancer-only, cancer + 1 condition, cancer + 2 or more conditions).MethodsUtilizing a population-based sample of 2019 older cancer survivors, we tested associations between comorbid conditions and the HRQOL outcomes using generalized linear models. HRQOL domains were assessed using Patient-Reported Outcome Measurement Information System® (PROMIS®) measures. Comorbidity was assessed via self-report.ResultsCancer survivors with lung disease reported significantly worse physical functioning (β = - 4.96, p < 0.001), survivors with arthritis reported significantly higher pain (β = 4.37, p < 0.001), and survivors with CVD reported significantly higher fatigue (β = 3.45, p < 0.001) compared to survivors without each condition. Having cancer + 1 condition was not as strongly associated with all outcomes as when individual conditions were tested (e.g. pain: β = 3.09, p < 0.001). Having 2+ comorbidities had a stronger association with all outcomes (e.g. physical function: β = - 7.51, p < 0.001) than examining conditions individually.ConclusionsKnowing the specific comorbid condition profile of an older cancer survivor provides insight into specific HRQOL outcomes that may be impaired in cancer survivorship, but understanding total comorbidity burden, regardless of the specific conditions, sheds light on survivors at-risk for multiple impairments in HRQOL. This information, taken together, can inform risk-stratified survivorship care.

Project description:Effective care models for treating older African Americans with depressive symptoms are needed.To determine whether a home-based intervention alleviates depressive symptoms and improves quality of life in older African Americans.Parallel, randomized trial stratified by recruitment site. Interviewers assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov: NCT00511680).A senior center and participants' homes from 2008 to 2010.African Americans aged 55 years or older with depressive symptoms.A multicomponent, home-based intervention delivered by social workers or a wait-list control group that received the intervention at 4 months.Self-reported depression severity at 4 months (primary outcome) and depression knowledge, quality of life, behavioral activation, anxiety, function, and remission at 4 and 8 months.Of 208 participants (106 and 102 in the intervention and wait-list groups, respectively), 182 (89 and 93, respectively) completed 4 months and 160 (79 and 81, respectively) completed 8 months. At 4 months, participants in the intervention group showed reduced depression severity (difference in mean change in Patient Health Questionnaire-9 score from baseline, -2.9 [95% CI, -4.6 to -1.2]; difference in mean change in Center for Epidemiologic Studies Depression Scale score from baseline, -3.7 [CI, -5.4 to -2.1]); improved depression knowledge, quality of life, behavioral activation, and anxiety (P < 0.001); and improved function (P = 0.014) compared with wait-list participants. More intervention than wait-list participants entered remission at 4 months (43.8% vs. 26.9%). After treatment, control participants showed benefits similar in magnitude to those of participants in the initial intervention group. Those in the initial intervention group maintained benefits at 8 months.The study had a small sample, short duration, and differential withdrawal rate.A home-based intervention delivered by social workers could reduce depressive symptoms and enhance quality of life in most older African Americans.National Institute of Mental Health.

Dataset Information

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

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

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

Similar Datasets

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