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Translating a Dementia Caregiver Intervention Into a Mobile Application

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ClinicalTrials.gov Identifier: NCT04330482
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
University of Rhode Island
Information provided by (Responsible Party):
Geoffrey Tremont, Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Caregiver Burnout Behavioral: CARE-Well App Behavioral: Internet Links Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Translating a Dementia Caregiver Intervention Into a Mobile Application
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
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.
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.

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




Primary Outcome Measures :
  1. Recruitment [ Time Frame: 3 months ]
    Percentage of participants recruited from each referral site.

  2. Randomization [ Time Frame: 3 months ]
    Percentage of participants who decline participation because of randomization.

  3. Study enrollment rate and retention [ Time Frame: 3 months ]
    Percentage of participants enrolled and who remain enrolled for the duration of the study.

  4. Intervention Adherence [ Time Frame: 3 months ]
    Percentage of participants who adhered to their respective interventions

  5. Timing of Assessments [ Time Frame: 3 months ]
    Percentage of assessments completed within two weeks of study enrollment.

  6. Completion Rates [ Time Frame: 3 months ]
    Percentage of participants who completed the intervention.

  7. 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.

  8. Frequency of Tablet/App Use After Formal Trial [ Time Frame: 3 months ]
    Percentage of time participants in a subset of caregivers (10 from each group) continued to use tablet/App after formal trial as an estimate of sustainability.

  9. App Technology Satisfaction [ Time Frame: 3 months ]
    Percent satisfied or very satisfied with App technology.

  10. App Content Satisfaction [ Time Frame: 3 months ]
    Percent satisfied or very satisfied with App content.


Secondary Outcome Measures :
  1. Center for Epidemiologic Studies Depression Scale [ Time Frame: 3 months ]
    Depression scale; 0-30 points; higher scores indicate worse outcome.

  2. Zarit Burden Interview [ Time Frame: 3 months ]
    Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.

  3. Revised Memory and Behavior Problem Checklist [ Time Frame: 3 months ]
    Caregiver reaction to problem behaviors; 3 categories: Memory: 0-28 points; Behavior: 0-32 points; Depression: 0-36 points. Higher scores indicate worse outcomes.

  4. Desire to Institutionalize Scale [ Time Frame: 3 months ]
    Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).

  5. Resource Utilization in Dementia - Lite Version [ Time Frame: 3 months ]
    A proxy-report questionnaire designed to quantify the formal health and social care cost of patients with dementia. Scores range from 22 to 110, and the higher the score the greater the perceived burden of the caregiver.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330482


Contacts
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Contact: Taylor R Maynard, BS 401-444-6629 961457@lifespan.org
Contact: Geoffrey Tremont, PhD 401-444-4500 gtremont@lifespan.org

Locations
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United States, Rhode Island
University of Rhode Island Active, not recruiting
Kingston, Rhode Island, United States, 02881
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Taylor R Maynard, BS    401-444-6629    961457@lifespan.org   
Contact: Geoffrey Tremont, PhD    401-444-4500    gtremont@lifespan.org   
Principal Investigator: Geoffrey Tremont, PhD         
Sub-Investigator: Jennifer Davis, PhD         
Sub-Investigator: Brian Ott, MD         
Sub-Investigator: Taylor Maynard, BS         
Sponsors and Collaborators
Rhode Island Hospital
University of Rhode Island
Investigators
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Principal Investigator: Geoffrey Tremont, PhD Rhode Island Hospital
Principal Investigator: Kunal Mankodiya, PhD University of Rhode Island
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Responsible Party: Geoffrey Tremont, Director of Neuropsychology, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT04330482    
Other Study ID Numbers: 1R21AG064410-01 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geoffrey Tremont, Rhode Island Hospital:
MobileHealth
Caregiving
Dementia
Alzheimer Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Burnout, Psychological
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Stress, Psychological
Behavioral Symptoms