N/A
N=40
Translating a Dementia Caregiver Intervention Into a Mobile Application
Dementia · Alzheimer Disease · Caregiver Burnout
Bottom Line
View on ClinicalTrials.gov: NCT04330482 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Randomization — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CARE-Well App (Behavioral); Internet Links (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rhode Island Hospital
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Randomization |
0; 0 | — |
| PRIMARY Study Enrollment Rate and Retention |
18; 16 | — |
| PRIMARY Intervention Adherence |
18; 16 | — |
| PRIMARY Timing of Assessments |
18; 16 | — |
| PRIMARY Completion Rates |
18; 16 | — |
| PRIMARY Interest in Continuation of Tablet/App Use After Formal Trial |
10; 10 | — |
| PRIMARY App Technology Satisfaction |
13; 12 | — |
| PRIMARY App Content Satisfaction |
13; 11 | — |
| SECONDARY Center for Epidemiologic Studies Depression Scale |
13.29; 13.94; 16.71; 17.38 | — |
| SECONDARY Zarit Burden Interview |
55.53; 56.56; 58.11; 57.56 | — |
| SECONDARY Revised Memory and Behavior Problem Checklist |
22.88; 22.00; 18.10; 11.56 | — |
| SECONDARY Desire to Institutionalize Scale |
0.82; 1.38; 1.12; 1.94 | — |
Summary
The overall goal of this development project is to combine elements of two efficacious interventions into a mobile health (mHealth) App for informal dementia caregivers. The investigators will conduct a 3-month feasibility trial of the newly-developed CARE-Well App in 40 dementia caregivers to establish acceptability and feasibility of the intervention, study procedures, and outcome measures.
Eligibility Criteria
Inclusion Criteria
- Adequate English-speaking and reading skills
- Provide at least 4 hours of supervision per day for the care recipient (either directly or by telephone)
- Live in the community (either with the care recipient or without)
- Have provided supervision/ assistance for at least 6 months prior to study enrollment and have no plans to place care recipient in long term care or to end their role as caregiver within 6 months of study enrollment.
- Report some degree of distress associated with caregiving
- Access to Wifi at home
Exclusion Criteria
- Major acute medical illness
- Severe mental illness (e.g. bipolar, schizophrenia)
- Diagnosed cognitive impairment
Data sourced from ClinicalTrials.gov (NCT04330482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.