Alzheimer Disease Clinical Trial
Official title:
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
Verified date | June 2023 |
Source | UConn Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | June 5, 2023 |
Est. primary completion date | June 5, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory HealthCare (IMCC) | Atlanta | Georgia |
United States | UConn Health (Geriatrics Associates) | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
UConn Health | Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Caregiver Mastery | Measured using a 4-item self-perceived caregiving competence scale. | pre-randomization; 3 months post-randomization; and 6 months post-randomization | |
Secondary | Change in Caregiver Reactions | The reactions caregivers have to the behavioral and psychological symptoms expressed by persons living with dementia, using the Revised Memory and Behavior Problem Checklist (RMBPC). The RMBPC is a 24-item scale capturing caregiver reactions to 24 memory and behavior problems. Scores are computed based on the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "upset" by each behavior. | pre-randomization; 3 months post-randomization for all; and 6 months post-randomization | |
Secondary | Change in Caregiver Stress | The Perceived Stress Scale (PSS) will be used to quantify caregiver stress levels. The PSS is a 14-item measure. Higher score reflects higher perceived stress | pre-randomization; 3 months post-randomization for all; and 6 months post-randomization |
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