Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers

NCT03033875 | Completed Results DMC

• 2 other identifiers: IRB000928121R01AG054079-01
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (3)

• Zarit Burden Inventory (ZBI) Score

  The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)

  Baseline, Month 3, Month 6

• State-Trait Anxiety Inventory (STAI) State Score

  The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.

  Baseline, Month 3, Month 6

• Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score

  The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.

  Baseline, Month 3, Month 6

Secondary Outcomes (4)

• Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score

  Baseline, Month 3, Month 6

• Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score

  Baseline, Month 3, Month 6

• Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score

  Baseline, Month 3, Month 6

• Perceived Stress Scale (PSS) Score

  Baseline, Month 3, Month 6

Study Arms (3)

Tele-Savvy Group

EXPERIMENTAL

Informal caregivers of persons living with Alzheimer's disease will be randomized to participate in the Tele-Savvy program immediately.

Behavioral: Tele-Savvy

Attention Control Group

OTHER

Informal caregivers of persons living with Alzheimer's disease will be randomized to participate in the Healthy Living Education Program. Persons in this group will be able to participate in the Tele-Savvy intervention after a delay of 6 months.

Behavioral: Healthy Living Education Program

Usual Care Group

NO INTERVENTION

Informal caregivers of persons living with Alzheimer's disease will be randomized to continue to receive care through whatever arrangement has been in place. Persons in this group will be able to participate in the Tele-Savvy intervention after a delay of 6 months.

Interventions

Tele-Savvy BEHAVIORAL

The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers will receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points.

Tele-Savvy Group

Healthy Living Education Program BEHAVIORAL

The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants will be asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant will also receive 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants will convene weekly for a video conference centered on the application of healthy living strategies. Facilitators will greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments.

Attention Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

• 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.

  PMID: 28460557 BACKGROUND

• 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.

  PMID: 29399825 BACKGROUND

• 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.

  PMID: 33640979 RESULT

• Bonds Johnson K, Higgins M, Epps F, Brewster GS, Alexander K, Hepburn K. Tele-Savvy Outcomes of Non-Hispanic Black American and White Caregivers. Gerontologist. 2024 Jan 1;64(1):gnad044. doi: 10.1093/geront/gnad044.

  PMID: 37067896 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Kenneth Hepburn
• Organization: Emory University

khepbur@emory.edu

404-712-9286

Study Officials

• Kenneth Hepburn, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: 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.

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: May 18, 2017
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: January 13, 2022
• Results First Posted: January 13, 2022

Record last verified: 2022-01

Locations

US (1)