Clinical trial NCT04330482: Translating a Dementia Caregiver Intervention Into a Mobile Application
Official title: Translating a Dementia Caregiver Intervention Into a Mobile Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Caregiver Burnout
Keywords: MobileHealth
Caregiving
Dementia
Alzheimer Disease
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
First posted: 2020-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Randomization
timeFrame: 3 months
measure: Study Enrollment Rate and Retention
timeFrame: 3 months
measure: Intervention Adherence
timeFrame: 3 months
measure: Timing of Assessments
timeFrame: 3 months
measure: Completion Rates
timeFrame: 3 months
measure: Interest in Continuation of Tablet/App Use After Formal Trial
timeFrame: 3 months
measure: App Technology Satisfaction
timeFrame: 3 months
measure: App Content Satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline and immediately Post-Intervention at 3 months
measure: Zarit Burden Interview
timeFrame: Baseline and immediately Post-Intervention at 3 months
measure: Revised Memory and Behavior Problem Checklist
timeFrame: Baseline and immediately Post-Intervention at 3 months
measure: Desire to Institutionalize Scale
timeFrame: Baseline and immediately Post-Intervention at 3 months
Other outcomes:
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Geoffrey Tremont, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rhode Island
name: Kunal Mankodiya, PhD
role: PRINCIPAL_INVESTIGATOR
References: