ArticleContemporary clinical trials2025
Promoting Daily Engagement in Meaningful Activity (DEMA) for people with cognitive impairment and their caregivers: Protocol for a randomized clinical trial.
Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundNearly one-third of older American adults have cognitive impairment (mild cognitive impairment or subjective cognitive decline). Cognitive impairment (CI) has an extraordinary impact on older adults, caregivers (CG), and society. Deteriorating life satisfaction in persons with CI (PwCI) and their primary CG is a prevalent problem. However, there is a paucity of research on a strength-based, positive health approach, and supportive care for PwCI and their CG.
objectivesThe promoting re-engagement in meaningful activity (PRIMA) study is a randomized controlled trial to test the efficacy of the Daily Engagement in Meaningful Activity (DEMA) intervention for PwCI and their CGs. The primary aim is to test DEMA's efficacy for improving life satisfaction in PwCI and their CGs over time. The second aim evaluates how the intervention improves activity performance, decreases depressive symptoms and anxiety in PwCI and CGs, and reduces CG burden over time. The third aim is to explore the treatment's efficacy among a sub-sample of PwCIs with (and without) depressive symptoms (Patient Health Questionnaire (PHQ)-9 ≥ 5 at baseline) for improvement in health outcomes over time.
methodsThe study population consists of dyads, a PwCI and their CG. The PwCI must be 60 years old and have CI. A total of 200 PwCI-CG dyads will be randomized to the DEMA or attention control group. Outcome assessments are conducted over 9-months (baseline, 10 days-, 3- and 6- months post-intervention). DISCUSSION: The DEMA results will inform care for the broader PwCI and CG population in community and home-based settings.
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