Translating a Dementia Caregiver Intervention Into a Mobile Application

Sponsor

Rhode Island Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04330482

Collaborator

University of Rhode Island (Other)

Enrollment

Locations

Arms

28.5

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Alzheimer Disease Caregiver Burnout	Behavioral: CARE-Well App Behavioral: Internet Links	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Translating a Dementia Caregiver Intervention Into a Mobile Application

Actual Study Start Date :

Jan 13, 2020

Actual Primary Completion Date :

May 30, 2022

Actual Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Internet Links 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 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.
Experimental: CARE-Well App 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 Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.

Arm

Intervention/Treatment

Other: Internet Links

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

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.

Experimental: CARE-Well App

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

Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.

Outcome Measures

Primary Outcome Measures

Recruitment [3 months]
Percentage of participants recruited from each referral site.
Randomization [3 months]
Percentage of participants who decline participation because of randomization.
Study enrollment rate and retention [3 months]
Percentage of participants enrolled and who remain enrolled for the duration of the study.
Intervention Adherence [3 months]
Percentage of participants who adhered to their respective interventions
Timing of Assessments [3 months]
Percentage of assessments completed within two weeks of study enrollment.
Completion Rates [3 months]
Percentage of participants who completed the intervention.
Interest in Continuation of Tablet/App Use After Formal Trial [3 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.
Frequency of Tablet/App Use After Formal Trial [3 months]
Percentage of time participants in a subset of caregivers (10 from each group) continued to use tablet/App after formal trial as an estimate of sustainability.
App Technology Satisfaction [3 months]
Percent satisfied or very satisfied with App technology.
App Content Satisfaction [3 months]
Percent satisfied or very satisfied with App content.

Secondary Outcome Measures

Center for Epidemiologic Studies Depression Scale [3 months]
Depression scale; 0-30 points; higher scores indicate worse outcome.
Zarit Burden Interview [3 months]
Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.
Revised Memory and Behavior Problem Checklist [3 months]
Caregiver reaction to problem behaviors; 3 categories: Memory: 0-28 points; Behavior: 0-32 points; Depression: 0-36 points. Higher scores indicate worse outcomes.
Desire to Institutionalize Scale [3 months]
Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).
Resource Utilization in Dementia - Lite Version [3 months]
A proxy-report questionnaire designed to quantify the formal health and social care cost of patients with dementia. Scores range from 22 to 110, and the higher the score the greater the perceived burden of the caregiver.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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