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Translating a Dementia Caregiver Intervention Into a Mobile Application

Not Applicable
Completed
Conditions
Caregiver Burnout
Dementia
Alzheimer Disease
Interventions
Behavioral: CARE-Well App
Behavioral: Internet Links
Registration Number
NCT04330482
Lead Sponsor
Rhode Island Hospital
Brief 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.

Detailed Description

Caring for a person with dementia is a highly stressful activity and is associated with negative physical and mental health consequences, including increased risk of depression and worse reported health-related quality of life. The proposed project aims to develop and translate an evidence-based, multi-component intervention into a mHealth App that has the potential to increase dementia caregivers' access to support and care.

The investigators will conduct a feasibility trial, in which 40 dementia caregivers will be randomized to receive a computer tablet preloaded with the CARE-well App or preloaded with internet links relevant to dementia and caregiving. Paper outcome measures will be assessed at baseline and end of intervention (3 months) during each study visit. To measure sustainability of the App, the first 10 caregivers from each group will be offered the tablets for an additional month to monitor usage of the App outside the formal trial. The goal of this aim is to determine feasibility of the intervention, study procedures, and outcome measures.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CARE-Well AppCARE-Well AppA tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
Internet LinksInternet LinksA tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Primary Outcome Measures
NameTimeMethod
Timing of Assessments3 months

Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.

Interest in Continuation of Tablet/App Use After Formal Trial3 months

Percentage of participants in a subset of caregivers (10 from each group) interested in continuing to use tablet/App use after formal trial as an estimate of sustainability.

Randomization3 months

Percentage of participants who decline participation because of randomization.

App Technology Satisfaction3 months

Percentage of participants satisfied or very satisfied with App technology.

Study Enrollment Rate and Retention3 months

Percentage of participants enrolled and who remain enrolled for the duration of the study.

Intervention Adherence3 months

Percentage of participants who used the internet links or the app for the 3-month intervention period.

Completion Rates3 months

Percentage of participants who completed the intervention.

App Content Satisfaction3 months

Percentage of participants satisfied or very satisfied with App content.

Secondary Outcome Measures
NameTimeMethod
Desire to Institutionalize ScaleBaseline and immediately Post-Intervention at 3 months

Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).

Center for Epidemiologic Studies Depression ScaleBaseline and immediately Post-Intervention at 3 months

Depression scale; 0-30 points; higher scores indicate worse outcome.

Zarit Burden InterviewBaseline and immediately Post-Intervention at 3 months

Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.

Revised Memory and Behavior Problem ChecklistBaseline and immediately Post-Intervention at 3 months

Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.

Trial Locations

Locations (2)

University of Rhode Island

🇺🇸

Kingston, Rhode Island, United States

Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

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