Clinical trial NCT05080777: Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
Official title: Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Neurodegenerative Diseases
Mental Disorders
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2021-10-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three Tele-Savvy programs, with 10 caregivers in each Tele-Savvy program cohort, will be held sequentially at each health care system site, for a total of 60 caregivers in 6 Tele-Savvy cohorts. Recruitment will occur in three waves, whereby caregivers will be randomly assigned at a 3:2 ratio to either Tele-Savvy or the attention control group until the first Tele-Savvy cohort is filled (first wave), followed by the same randomization procedure until the second and third Tele-Savvy cohorts are filled.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in Caregiver Mastery
timeFrame: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)
Secondary outcomes:
measure: Change in Caregiver Reactions
timeFrame: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)
measure: Change in Caregiver Stress
timeFrame: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only)
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health (Geriatrics Associates)
state: Connecticut
city: Atlanta
country: United States
facility: Emory HealthCare (IMCC)
state: Georgia
Study officials:
affiliation: UConn Health
name: Richard H. Fortinsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: