Translating a Dementia Caregiver Intervention Into a Mobile Application

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Caregiver Burnout
• Intervention / Treatment: Behavioral: Internet Links; Behavioral: CARE-Well App

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Kingston, Rhode Island, United States, 02881
      • University of Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomization	Percentage of participants who decline participation because of randomization.	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
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
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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: University of Rhode Island
• Investigators: Principal Investigator: Geoffrey Tremont, PhD, Rhode Island Hospital; Principal Investigator: Kunal Mankodiya, PhD, University of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Dementia; Alzheimer Disease; Caregiving; MobileHealth
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Stress, Psychological; Tauopathies; Dementia; Alzheimer Disease; Caregiver Burden
• Other Study ID Numbers: 1R21AG064410-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No