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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033875
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kenneth Hepburn, Emory University

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Behavioral: Tele-Savvy Behavioral: Healthy Living Education Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers
Actual Study Start Date : May 18, 2017
Actual Primary Completion Date : December 4, 2020
Actual Study Completion Date : December 4, 2020


Arm Intervention/treatment
Experimental: Tele-Savvy Group
Informal caregivers of persons living with Alzheimer's disease will be randomized to participate in the Tele-Savvy program immediately.
Behavioral: Tele-Savvy
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.

Attention Control Group
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
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.

No Intervention: Usual Care Group
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.



Primary Outcome Measures :
  1. Zarit Burden Inventory (ZBI) Score [ Time Frame: Baseline, Month 3, Month 6 ]
    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)

  2. State-Trait Anxiety Inventory (STAI) State Score [ Time Frame: Baseline, Month 3, Month 6 ]
    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.

  3. Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score [ Time Frame: Baseline, Month 3, Month 6 ]
    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.


Secondary Outcome Measures :
  1. Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score [ Time Frame: Baseline, Month 3, Month 6 ]
    The RMBPC is a 24-item instrument that assesses behaviors in persons with dementia and caregiver responses to them. Caregiver reactions to behaviors are scored as 0 = not at all upsetting to 4 = extremely upsetting. Total caregiver reaction scores range from 0 to 96 with higher scores indicating greater feelings of being upset by behaviors of those with dementia that they are providing care for.

  2. Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score [ Time Frame: Baseline, Month 3, Month 6 ]
    The Caregiving Competence Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = not at all and 4 = very much. Total scores for this subscale range from 4 to 16 and higher scores indicate greater feelings of competence with caregiving.

  3. Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score [ Time Frame: Baseline, Month 3, Month 6 ]
    The Management of Situation Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = never and 4 = very often. Total scores for this subscale range from 4 to 16 and higher scores indicate greater management of caregiving situations.

  4. Perceived Stress Scale (PSS) Score [ Time Frame: Baseline, Month 3, Month 6 ]
    The PSS is 14-item Likert-type questionnaire. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and certain items are reverse scored so that higher total scores reflect higher perceived stress.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033875


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kenneth Hepburn, PhD Emory University
  Study Documents (Full-Text)

Documents provided by Kenneth Hepburn, Emory University:
Informed Consent Form  [PDF] December 19, 2019

Publications of Results:
Other Publications:
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Responsible Party: Kenneth Hepburn, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03033875    
Other Study ID Numbers: IRB00092812
1R01AG054079-01 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2017    Key Record Dates
Results First Posted: January 13, 2022
Last Update Posted: January 13, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders