Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems

Not Applicable

Completed

Conditions: Brain Diseases
Neurodegenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Alzheimer Disease
Dementia

Interventions: Behavioral: Tele-Savvy
Behavioral: Caregiving During Crisis (Educational Program)

Registration Number: NCT05080777

Lead Sponsor: UConn Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-Savvy Group	Tele-Savvy	The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Attention Control Group	Caregiving During Crisis (Educational Program)	The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.

Primary Outcome Measures

Name	Time	Method
Change in Caregiver Mastery	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 Outcome Measures

Name	Time	Method
Change in Caregiver Reactions	pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)	The reactions caregivers have to the behavioral and psychological symptoms expressed by persons living with dementia, were assessed 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 endorsed behavior. Reactions are assessed by asking how "upsetting" each behavior is to the caregiver on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely). Scores on the scale can range from 0-96, with higher scores meaning a worse outcome.
Change in Caregiver Stress	pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only)	The Perceived Stress Scale (PSS) is a 14-item instrument designed to measure the degree to which situations in one's life are appraised as stressful. Higher score reflects higher perceived stress. PSS items were designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading. The scale also includes a number of direct queries about current levels of experienced stress. Each item is scored from 0 (never) to 4 (very often), for a possible score range of 0-56, with higher scores meaning worse outcomes.

Trial Locations

Locations (2): UConn Health (Geriatrics Associates)
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Farmington, Connecticut, United States
Emory HealthCare (IMCC)
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Atlanta, Georgia, United States