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

Primary Purpose

Alzheimer Disease, Dementia, Brain Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-Savvy
Caregiving During Crisis (Educational Program)
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • UConn Health (Geriatrics Associates)
  • Emory HealthCare (IMCC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-Savvy Group

Attention Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Caregiver Mastery
Measured using a 4-item self-perceived caregiving competence scale.

Secondary Outcome Measures

Change in Caregiver Reactions
The reactions caregivers have to the behavioral and psychological symptoms expressed by persons living with dementia, 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 behavior.
Change in Caregiver Stress
The Perceived Stress Scale (PSS) will be used to quantify caregiver stress levels. The PSS is a 14-item measure. Higher score reflects higher perceived stress

Full Information

First Posted
October 11, 2021
Last Updated
June 22, 2023
Sponsor
UConn Health
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05080777
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
June 5, 2023 (Actual)
Study Completion Date
June 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurocognitive Disorders, Neurodegenerative Diseases, Mental Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-Savvy Group
Arm Type
Experimental
Arm Description
The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Arm Title
Attention Control Group
Arm Type
Active Comparator
Arm Description
The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.
Intervention Type
Behavioral
Intervention Name(s)
Tele-Savvy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caregiving During Crisis (Educational Program)
Intervention Description
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 Outcome Measure Information:
Title
Change in Caregiver Mastery
Description
Measured using a 4-item self-perceived caregiving competence scale.
Time Frame
pre-randomization; 3 months post-randomization; and 6 months post-randomization
Secondary Outcome Measure Information:
Title
Change in Caregiver Reactions
Description
The reactions caregivers have to the behavioral and psychological symptoms expressed by persons living with dementia, 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 behavior.
Time Frame
pre-randomization; 3 months post-randomization for all; and 6 months post-randomization
Title
Change in Caregiver Stress
Description
The Perceived Stress Scale (PSS) will be used to quantify caregiver stress levels. The PSS is a 14-item measure. Higher score reflects higher perceived stress
Time Frame
pre-randomization; 3 months post-randomization for all; and 6 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard H. Fortinsky, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health (Geriatrics Associates)
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Emory HealthCare (IMCC)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

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

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