Translating a Dementia Caregiver Intervention Into a Mobile Application

NCT04330482 | Completed Results

• 1 other identifier: 1R21AG064410-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Dementia; Alzheimer Disease; Caregiver Burnout

Keywords

MobileHealth; Caregiving; Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Center for Epidemiologic Studies Depression Scale

  Baseline and immediately Post-Intervention at 3 months

• Zarit Burden Interview

  Baseline and immediately Post-Intervention at 3 months

• Revised Memory and Behavior Problem Checklist

  Baseline and immediately Post-Intervention at 3 months

• Desire to Institutionalize Scale

  Baseline and immediately Post-Intervention at 3 months

Study Arms (2)

Internet Links

OTHER

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

CARE-Well App

EXPERIMENTAL

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

Interventions

CARE-Well App BEHAVIORAL

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

CARE-Well App

Internet Links BEHAVIORAL

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.

Internet Links

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major acute medical illness
• Severe mental illness (e.g. bipolar, schizophrenia)
• Diagnosed cognitive impairment

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Rhode Island: collaborator

Study Sites (2)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Geoffrey Tremont
• Organization: Rhode Island Hospital

gtremont@lifespan.org

401-444-4500

Study Officials

• Geoffrey Tremont, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Kunal Mankodiya, PhD

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neuropsychology

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: April 1, 2020
• Study Start: January 13, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)