Translating a Dementia Caregiver Intervention Into a Mobile Application
Primary Purpose
Dementia, Alzheimer Disease, Caregiver Burnout
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CARE-Well App
Internet Links
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring MobileHealth, Caregiving, Dementia, Alzheimer Disease
Eligibility Criteria
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
Sites / Locations
- University of Rhode Island
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Internet Links
CARE-Well App
Arm Description
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.
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
Outcomes
Primary Outcome Measures
Randomization
Percentage of participants who decline participation because of randomization.
Study Enrollment Rate and Retention
Percentage of participants enrolled and who remain enrolled for the duration of the study.
Intervention Adherence
Percentage of participants who used the internet links or the app for the 3-month intervention period.
Timing of Assessments
Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.
Completion Rates
Percentage of participants who completed the intervention.
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.
App Technology Satisfaction
Percentage of participants satisfied or very satisfied with App technology.
App Content Satisfaction
Percentage of participants satisfied or very satisfied with App content.
Secondary Outcome Measures
Center for Epidemiologic Studies Depression Scale
Depression scale; 0-30 points; higher scores indicate worse outcome.
Zarit Burden Interview
Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.
Revised Memory and Behavior Problem Checklist
Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.
Desire to Institutionalize Scale
Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).
Full Information
NCT ID
NCT04330482
First Posted
March 19, 2020
Last Updated
September 6, 2023
Sponsor
Rhode Island Hospital
Collaborators
University of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT04330482
Brief Title
Translating a Dementia Caregiver Intervention Into a Mobile Application
Official Title
Translating a Dementia Caregiver Intervention Into a Mobile Application
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
University of Rhode Island
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Caregiver Burnout
Keywords
MobileHealth, Caregiving, Dementia, Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet Links
Arm Type
Other
Arm Description
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.
Arm Title
CARE-Well App
Arm Type
Experimental
Arm Description
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
CARE-Well App
Intervention Description
Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
Intervention Type
Behavioral
Intervention Name(s)
Internet Links
Intervention Description
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.
Primary Outcome Measure Information:
Title
Randomization
Description
Percentage of participants who decline participation because of randomization.
Time Frame
3 months
Title
Study Enrollment Rate and Retention
Description
Percentage of participants enrolled and who remain enrolled for the duration of the study.
Time Frame
3 months
Title
Intervention Adherence
Description
Percentage of participants who used the internet links or the app for the 3-month intervention period.
Time Frame
3 months
Title
Timing of Assessments
Description
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
Title
Completion Rates
Description
Percentage of participants who completed the intervention.
Time Frame
3 months
Title
Interest in Continuation of Tablet/App Use After Formal Trial
Description
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
Title
App Technology Satisfaction
Description
Percentage of participants satisfied or very satisfied with App technology.
Time Frame
3 months
Title
App Content Satisfaction
Description
Percentage of participants satisfied or very satisfied with App content.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression Scale
Description
Depression scale; 0-30 points; higher scores indicate worse outcome.
Time Frame
Baseline and immediately Post-Intervention at 3 months
Title
Zarit Burden Interview
Description
Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.
Time Frame
Baseline and immediately Post-Intervention at 3 months
Title
Revised Memory and Behavior Problem Checklist
Description
Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.
Time Frame
Baseline and immediately Post-Intervention at 3 months
Title
Desire to Institutionalize Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Tremont, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kunal Mankodiya, PhD
Organizational Affiliation
University of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rhode Island
City
Kingston
State/Province
Rhode Island
ZIP/Postal Code
02881
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Translating a Dementia Caregiver Intervention Into a Mobile Application
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