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Completed

NCT Number: NCT04330482

Translating a Dementia Caregiver Intervention Into a Mobile Application

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rhode Island, Kingston, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARE-Well App

Behavioral

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

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.

Primary outcomes

  1. Randomization

    Time frame: 3 months

    Percentage of participants who decline participation because of randomization.

  2. Study Enrollment Rate and Retention

    Time frame: 3 months

    Percentage of participants enrolled and who remain enrolled for the duration of the study.

  3. Intervention Adherence

    Time frame: 3 months

    Percentage of participants who used the internet links or the app for the 3-month intervention period.

  4. Timing of Assessments

    Time frame: 3 months

    Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.

  5. Completion Rates

    Time frame: 3 months

    Percentage of participants who completed the intervention.

  6. Interest in Continuation of Tablet/App Use After Formal Trial

    Time frame: 3 months

    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.

  7. App Technology Satisfaction

    Time frame: 3 months

    Percentage of participants satisfied or very satisfied with App technology.

  8. App Content Satisfaction

    Time frame: 3 months

    Percentage of participants satisfied or very satisfied with App content.

Secondary outcomes

  1. Center for Epidemiologic Studies Depression Scale

    Time frame: Baseline and immediately Post-Intervention at 3 months

    Depression scale; 0-30 points; higher scores indicate worse outcome.

  2. Zarit Burden Interview

    Time frame: Baseline and immediately Post-Intervention at 3 months

    Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.

  3. Revised Memory and Behavior Problem Checklist

    Time frame: Baseline and immediately Post-Intervention at 3 months

    Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.

  4. Desire to Institutionalize Scale

    Time frame: Baseline and immediately Post-Intervention at 3 months

    Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • University of Rhode Island

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2020
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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