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

UConn Health

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05080777

U21-139-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Tele-Savvy Group

Experimental group

Description:

The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.

Treatment:

Behavioral: Tele-Savvy

Attention Control Group

Active Comparator group

Description:

The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.

Treatment:

Behavioral: Caregiving During Crisis (Educational Program)