Translating a Dementia Caregiver Intervention Into a Mobile Application

Study Overview
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Brief Summary
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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
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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.

Official Title
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Translating a Dementia Caregiver Intervention Into a Mobile Application

Conditions
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Dementia, Alzheimer Disease, Caregiver Burnout

Intervention / Treatment
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* Behavioral: CARE-Well App
* Behavioral: Internet Links


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A full-scale randomized, controlled trial: 20 participants will be randomized to receive a tablet pre-loaded with a list of internet links relevant to dementia caregiving and 20 participants will be randomized to receive a tablet pre-loaded with the CARE-Well App. Both groups will be instructed to use their tablets at least 4 times per week for 3 months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Internet Links<br>A 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. | Behavioral: Internet Links<br>* 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.<br>|
| Experimental: CARE-Well App<br>A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months. | Behavioral: CARE-Well App<br>* Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Randomization | Percentage of participants who decline participation because of randomization. | 3 months | 
| Study Enrollment Rate and Retention | Percentage of participants enrolled and who remain enrolled for the duration of the study. | 3 months | 
| Intervention Adherence | Percentage of participants who used the internet links or the app for the 3-month intervention period. | 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. | 3 months | 
| Completion Rates | Percentage of participants who completed the intervention. | 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. | 3 months | 
| App Technology Satisfaction | Percentage of participants satisfied or very satisfied with App technology. | 3 months | 
| App Content Satisfaction | Percentage of participants satisfied or very satisfied with App content. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiologic Studies Depression Scale | Depression scale; 0-30 points; higher scores indicate worse outcome. | Baseline and immediately Post-Intervention at 3 months | 
| Zarit Burden Interview | Caregiver burden scale; 0-88 points; higher scores indicate worse outcome. | 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. | 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). | Baseline and immediately Post-Intervention at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MobileHealth, Caregiving, Dementia, Alzheimer Disease