Clinical trial NCT03033875: Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers
Official title: Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-01-27
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned in a 2:2:1 ratio to the Tele-Savvy intervention, Healthy Living intervention, or usual care condition. Participants in the Healthy Living and usual care arms can take part i the Tele-Savvy intervention after a delay of 6 months.
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the psychoeducational program "Tele-Savvy." Tele-Savvy is an internet based, group education program developed from an in person program called Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving healthy lifestyle education and then Tele-Savvy education 6 months later) or a usual care group (receiving Tele-Savvy education 6 months later). Each program takes 43 days to complete.

Detailed description: This study addresses the reliance on family members to provide virtually all community-based care for 5.3 million persons living with Alzheimer's disease and other dementias, a population that will likely triple in the next 35 years. Unless researchers soon find a way to prevent and cure dementing illnesses like Alzheimer's, the country will continue to face an urgent need to find ways to sustain and bolster the capacity of these family caregivers to manage the multiple daily care challenges they face and to preserve their well-being while doing so. Without family caregivers, the burden of care could well overwhelm the formal components of our care system. A number of psychoeducation programs for caregivers have been effective in relieving distress, increasing self-efficacy, managing caregiving challenges, and enabling caregivers to sustain care over longer periods of time. However, many Alzheimer's caregivers cannot take part in these programs because virtually all such programs require caregivers to arrange care for the care recipient while the caregivers attend the programs. These are obstacles in rural or remote areas where transportation issues further restrict caregivers' already limited access to caregiver programs, but they are no less a problem in inner cities and suburbs. These obstacles highlight a substantial challenge to our ability to rely on caregivers as a continuing care resource for persons living with Alzheimer's disease: there is a need for theory-driven psychoeducation programs that can be made readily available to caregivers who may not be able to attend in-person programs.

This is a randomized trial to test a program designed to meet this critical need. This study will test Tele-Savvy, an internet-based program based on the widely disseminated, in-person Savvy Caregiver psychoeducation program. Delivered in scheduled videoconferences and independently viewed on-line video lessons, Tele-Savvy aims to develop/enhance caregivers' skills and caregiving mastery, reduce adverse effects of caregiving, and improve the quality of the lives of caregivers and care recipients.

Caregivers will be randomly assigned either to immediate Tele-Savvy participation groups or to attention control or usual care groups that are invited to participate in Tele-Savvy six months after baseline data collection. Each program takes 43 days to complete. In those 43 days, participants will be asked to take part in a video conference once per week (60-90 minutes) and view daily video lessons (7-15 minutes). The study includes 5 interviews over the course of the 12 month study; the interviews at baseline and months 3 and 6 assess the study outcome measures. These interviews will discuss participant's experience as a caregiver. All interviews will be limited to 60 minutes.

Eligibility criteria: Inclusion Criteria:

* Informal caregivers (family/friends) of persons living with Alzheimer's disease or another dementia
* Participants must be providing at least 4 hours per day unpaid assistance, on average, for a person in the early-middle stage of illness (Clinical Dementia Rating of greater than or equal to 1 by home ADC) who is community-dwelling and for whom there is no established plan for institutionalization in the next six months
* Caregiver may or may not reside with their care recipient, but care recipients must live in the community and not in an assisted living facility, nursing home, or another institutional setting
* Must have access to a computer or a mobile device with adequate internet connection, microphone, and speakers (to be able to participate in teleconferences) and be able to use email
* Able to read, speak and understand English

Exclusion Criteria:

* The participant must not be involved in another caregiver training study and must not have participated in in-person Savvy Caregiver Program or Tele-Savvy previously
* Uncorrectable vision or hearing deficits that might impede participation

Primary outcomes:
measure: Zarit Burden Inventory (ZBI) Score
timeFrame: Baseline, Month 3, Month 6
measure: State-Trait Anxiety Inventory (STAI) State Score
timeFrame: Baseline, Month 3, Month 6
measure: Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
measure: Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
timeFrame: Baseline, Month 3, Month 6
measure: Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score
timeFrame: Baseline, Month 3, Month 6
measure: Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score
timeFrame: Baseline, Month 3, Month 6
measure: Perceived Stress Scale (PSS) Score
timeFrame: Baseline, Month 3, Month 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Hepburn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kovaleva M, Blevins L, Griffiths PC, Hepburn K. An Online Program for Caregivers of Persons Living With Dementia: Lessons Learned. J Appl Gerontol. 2019 Feb;38(2):159-182. doi: 10.1177/0733464817705958. Epub 2017 May 1.
citation: Kovaleva MA, Bilsborough E, Griffiths PC, Nocera J, Higgins M, Epps F, Kilgore K, Lindauer A, Morhardt D, Shah RC, Hepburn K. Testing Tele-Savvy: Protocol for a randomized controlled trial. Res Nurs Health. 2018 Apr;41(2):107-120. doi: 10.1002/nur.21859. Epub 2018 Feb 5.
citation: Hepburn K, Nocera J, Higgins M, Epps F, Brewster GS, Lindauer A, Morhardt D, Shah R, Bonds K, Nash R, Griffiths PC. Results of a Randomized Trial Testing the Efficacy of Tele-Savvy, an Online Synchronous/Asynchronous Psychoeducation Program for Family Caregivers of Persons Living with Dementia. Gerontologist. 2022 Apr 20;62(4):616-628. doi: 10.1093/geront/gnab029.