Translating a Dementia Caregiver Intervention Into a Mobile Application

NCT ID: NCT04330482

Last Updated: 2023-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2022-05-30

Brief Summary

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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

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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.

Conditions

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Dementia Alzheimer Disease Caregiver Burnout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

Internet Links

Intervention Type 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.

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.

Group Type EXPERIMENTAL

CARE-Well App

Intervention Type BEHAVIORAL

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

Interventions

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CARE-Well App

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rhode Island

OTHER

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Geoffrey Tremont

Director of Neuropsychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geoffrey Tremont, PhD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Kunal Mankodiya, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

Locations

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University of Rhode Island

Kingston, Rhode Island, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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1R21AG064410-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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