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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
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kenneth Hepburn, Emory University

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date February 12, 2021
Actual Study Start Date  ICMJE May 18, 2017
Actual Primary Completion Date December 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Change in Zarit Burden Inventory (ZBI) Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    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)
  • Change in State-Trait Anxiety Inventory (STAI) Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The STAI is a 20-item 4-point Likert scale commonly used measure of trait and state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety.
  • Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Change in Cornell Scale for Depression in Dementia (CSDD) Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The CSDD is a 19 item scale designed to assess depression in elderly residents with dementia. Scores ≥ 12 indicate probable depression.
  • Change in Alzheimer's Disease Related Quality of Life (ADRQL) Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The ADRQL is a research instrument used to assess health-related quality of life (HRQOL) in persons with Alzheimer disease (AD) and other types of dementia. The total score for the ADRQL is computed by summing the values assigned to the responses, dividing the sum by the maximum value for the scale and multiplying the results by 100 to obtain a percentage score of 0 to 100. A higher score reflects a higher quality of life.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Change in Perceived Stress Scale (PSS) Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The PSS is 14-item Likert-type questionnaire. Higher scores reflect higher perceived stress.
  • Change in Dyadic Relationship Scale Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The Dyadic Relationship Scale is an 11-item scale that assesses dyadic strain and dyadic interaction perceived by a caregiver. A lower score indicates more strain.
  • Change in Ways of Coping Scale Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The Ways of Coping Scale is a 42-item scale with 4-point Likert responses. It identifies emotion- and problem-focused coping responses. Raw scores describe the coping effort for each of the eight types of coping. High raw scores indicate that the person often used the behaviors described by that scale in coping with the stressful event.
  • Change in Revised Memory and Behavior Problem Checklist (RMBPC) Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The RMBPC is a 22-item Likert scale instrument that assesses patient behaviors and caregiver responses to them. Scores are computed for the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "distressed" by each behavior.
  • Change in Self-Rated Health Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    Participants are asked to rate their health on a scale from 1-5 where "1" represents excellent and "5" represents poor health. A total higher score indicates poorer health.
  • Change in the Caregiver Assessment of Behavioral Skill - Self Report (CAB-SR) Measure Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The CAB-SR measures managing behavioral symptoms associated with Alzheimer's disease. Final scores can range from 0-35 with higher scores indicating greater behavioral skill.
  • Change in the Pearlin Measure Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    Final Scores can range from 14-56 with higher scores indicating greater caregiver mastery.
  • Change in Alzheimer's Disease Related Quality of Life (ADRQL) Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The ADRQL is a research instrument used to assess health-related quality of life (HRQOL) in persons with Alzheimer disease (AD) and other types of dementia. The total score for the ADRQL is computed by summing the values assigned to the responses, dividing the sum by the maximum value for the scale and multiplying the results by 100 to obtain a percentage score of 0 to 100. A higher score reflects a higher quality of life.
  • Change in Positive Appraisal of Care Scale: Consequential Gain Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The Positive Appraisal of Care Scale: Consequential Gain subscale includes 6-items providing caregiver self-rating of benefits and positive experiences of caregiving. Caregivers rate their feelings from the prior two weeks on a 4-point scale where 0 is "not at all applicable" and 3 is "very much applicable". Total scores range from 0 to 18 with higher scores indicating greater positive feelings related to caregiving.
  • Change in Mindful Self-Care Scale Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    Five sub-scales of the Mindful Self-Care Scale will be used to assess caregiver self-care. The sub-scales used are those for supportive relationships (5 items), self-compassion and purpose (6), mindful relaxation (6), clinical (6), and general (3), for 26 items in total. Items are scored on a 5-point scale and the total score ranges from 26 to 130, where higher scores indicate greater self-care.
  • Change in Neuropsychological Inventory Questionnaire Score [ Time Frame: Baseline, Months 3, 6, 12 ]
    The Neuropsychological Inventory Questionnaire is a 12-item inventory assessing severity of change in mood states or behaviors reflecting mood of the person that is being cared for. The caregiver rates each item on a 3-point scale where 1 = Mild (noticeable but not significant change), 2 = Moderate (significant but not dramatic change), and 3 = Severe (a dramatic change). Total scores range from 12 to 36, with higher scores indicating increased changes in the symptoms of the patient with dementia who the caregiver is caring for.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Change in Perceived Stress Scale (PSS) Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The PSS is 14-item Likert-type questionnaire. Higher scores reflect higher perceived stress.
  • Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
  • Change in State-Trait Anxiety Inventory (STAI) Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The STAI is a 20-item 4-point Likert scale commonly used measure of trait and state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety.
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety - short form Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The PROMIS Anxiety short form measures anxious misery, fear, hyperarousal, and somatic symptoms associated with arousal and is based on the subjects' recall of feeling anxious in the past 7 days. There are 7 items in which answers are provided on a Likert-type scale. Higher score reflects greater anxiety.
  • Change in Zarit Burden Inventory (ZBI) Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    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)
  • Change in Dyadic Relationship Scale Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The Dyadic Relationship Scale is an 11-item scale that assesses dyadic strain and dyadic interaction perceived by a caregiver. A lower score indicates more strain.
  • Change in Ways of Coping Scale Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The Ways of Coping Scale is a 42-item scale with 4-point Likert responses. It identifies emotion- and problem-focused coping responses. Raw scores describe the coping effort for each of the eight types of coping. High raw scores indicate that the person often used the behaviors described by that scale in coping with the stressful event.
  • Change in Revised Memory and Behavior Problem Checklist (RMBPC) Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The RMBPC is a 22-item Likert scale instrument that assesses patient behaviors and caregiver responses to them. Scores are computed for the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "distressed" by each behavior.
  • Change in Self-Rated Health Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    Participants are asked to rate their health on a scale from 1-5 where "1" represents excellent and "5" represents poor health. A total higher score indicates poorer health.
  • Change in the Caregiver Assessment of Behavioral Skill - Self Report (CAB-SR) Measure Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    The CAB-SR measures managing behavioral symptoms associated with Alzheimer's disease. Final scores can range from 0-35 with higher scores indicating greater behavioral skill.
  • Change in the Pearlin Measure Score [ Time Frame: Baseline, Follow Up (Month 12) ]
    Final Scores can range from 14-56 with higher scores indicating greater caregiver mastery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers
Official Title  ICMJE Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers
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). They will participate in 5 interviews over the course of the 12 month study. These interviews will discuss participant's experience as a caregiver. All interviews will be limited to 60 minutes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Alzheimer Disease
  • Dementia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Tele-Savvy Group
    Informal caregivers of persons living with Alzheimer's disease will be randomized to participate in the Tele-Savvy program immediately.
    Intervention: Behavioral: Tele-Savvy
  • 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.
    Intervention: Behavioral: Healthy Living Education Program
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2020)
311
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
75
Actual Study Completion Date  ICMJE December 4, 2020
Actual Primary Completion Date December 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033875
Other Study ID Numbers  ICMJE IRB00092812
1R01AG054079-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Hepburn, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Kenneth Hepburn, PhD Emory University
PRS Account Emory University
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP