Translating a Dementia Caregiver Intervention Into a Mobile Application

Alzheimer Disease Clinical Trial

Official title:

Translating a Dementia Caregiver Intervention Into a Mobile Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330482
• Other study ID #: 1R21AG064410-01
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: September 2023
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Caregiver Burnout
• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	University of Rhode Island	Kingston	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Randomization	Percentage of participants who decline participation because of randomization.	3 months
Primary	Study Enrollment Rate and Retention	Percentage of participants enrolled and who remain enrolled for the duration of the study.	3 months
Primary	Intervention Adherence	Percentage of participants who used the internet links or the app for the 3-month intervention period.	3 months
Primary	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
Primary	Completion Rates	Percentage of participants who completed the intervention.	3 months
Primary	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
Primary	App Technology Satisfaction	Percentage of participants satisfied or very satisfied with App technology.	3 months
Primary	App Content Satisfaction	Percentage of participants satisfied or very satisfied with App content.	3 months
Secondary	Center for Epidemiologic Studies Depression Scale	Depression scale; 0-30 points; higher scores indicate worse outcome.	Baseline and immediately Post-Intervention at 3 months
Secondary	Zarit Burden Interview	Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.	Baseline and immediately Post-Intervention at 3 months
Secondary	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
Secondary	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