Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- UConn Health
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- Change in Caregiver Mastery
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia.
Detailed Description
This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia. A total of 100 caregivers, 50 at each study site, will participate in this pilot study. At each site, 30 caregivers will be randomly assigned to receive the Tele-Savvy intervention, and 20 caregivers will be randomly assigned to receive the self-guided Caregiving During Crisis online program. All 100 caregivers will complete identical self-administered questionnaires to measure the caregiver-specific outcome measures in this pilot study. Outcome measures will include caregiver mastery (primary outcome), caregiver response to specific memory and behavioral problems, and caregiver stress. Also, we will employ process measures of participation and engagement in the interventions for caregivers in both arms of the trial, as well as implementation outcomes via surveys with clinicians and Information Technology staff at each of the two clinical sites responsible for programming electronic medical records to enable capture and storage of caregiver outcomes.
Investigators
Fortinsky, Richard
Professor
UConn Health
Eligibility Criteria
Inclusion Criteria
- •Identified by EHR systems and confirmed by a health care provider as a family member or unpaid significant other who provides care at home for an older adult (age 65 or older) living with ADRD
- •English speaking
- •Able to understand study procedures and comply with them for the entire length of the study
- •Access to appropriate video and audio technology to be able to participate in interventions
Exclusion Criteria
- •Unwilling to be randomized to receive either Tele-Savvy or Caregiving During Crisis
- •Planning to admit the person living with ADRD to a nursing home on a long-term basis within 6 months of randomization.
Outcomes
Primary Outcomes
Change in Caregiver Mastery
Time Frame: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)
Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery.
Secondary Outcomes
- Change in Caregiver Reactions(pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only))
- Change in Caregiver Stress(pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only))