Skip to main content
OpenTrials
Completed

NCT Number: NCT05080777

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health (Geriatrics Associates), Farmington, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele-Savvy

Behavioral

A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.

Caregiving During Crisis (Educational Program)

Behavioral

The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.

Primary outcomes

  1. 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

  1. Change in Caregiver Reactions

    Time frame: 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.

  2. Change in Caregiver Stress

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Emory University

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2021
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.