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

NCT05080777 | Completed Results DMC

• 1 other identifier: U21-139-2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Caregiver Mastery

  Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery.

  pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)

Secondary Outcomes (2)

• Change in Caregiver Reactions

  pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)

• Change in Caregiver Stress

  pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only)

Study Arms (2)

Tele-Savvy Group

EXPERIMENTAL

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

Behavioral: Tele-Savvy

Attention Control Group

ACTIVE COMPARATOR

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

Behavioral: Caregiving During Crisis (Educational Program)

Interventions

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.

Tele-Savvy Group

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.

Attention Control Group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: lead
• Emory University: collaborator

Study Sites (2)

UConn Health (Geriatrics Associates)

Farmington, Connecticut, 06032, United States

Location

Emory HealthCare (IMCC)

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

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

Limitations and Caveats

Modest levels of outcome ascertainment at follow-up time points were due to the pragmatic nature of this pilot clinical trial, in which study participants (caregivers) received limited reminders from study personnel to submit follow-up self-administered questionnaires.

Results Point of Contact

• Title: Dr. Richard Fortinsky
• Organization: University of Connecticut Center on Aging

fortinsky@uchc.edu

860-679-8069

Study Officials

• Richard H. Fortinsky, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 18, 2021
• Study Start: September 28, 2021
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Locations

US (2)