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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
University of Rhode Island
Kingston, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Randomization
Percentage of participants who decline participation because of randomization.
Time frame: 3 months
Study Enrollment Rate and Retention
Percentage of participants enrolled and who remain enrolled for the duration of the study.
Time frame: 3 months
Intervention Adherence
Percentage of participants who used the internet links or the app for the 3-month intervention period.
Time frame: 3 months
Timing of Assessments
Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.
Time frame: 3 months
Completion Rates
Percentage of participants who completed the intervention.
Time frame: 3 months
Interest in Continuation of Tablet/App Use After Formal Trial
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.
Time frame: 3 months
App Technology Satisfaction
Percentage of participants satisfied or very satisfied with App technology.
Time frame: 3 months
App Content Satisfaction
Percentage of participants satisfied or very satisfied with App content.
Time frame: 3 months
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Center for Epidemiologic Studies Depression Scale
Depression scale; 0-30 points; higher scores indicate worse outcome.
Time frame: Baseline and immediately Post-Intervention at 3 months
Zarit Burden Interview
Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.
Time frame: Baseline and immediately Post-Intervention at 3 months
Revised Memory and Behavior Problem Checklist
Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.
Time frame: Baseline and immediately Post-Intervention at 3 months
Desire to Institutionalize Scale
Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).
Time frame: Baseline and immediately Post-Intervention at 3 months