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Trial record 1 of 1 for:    NCT04060355
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Savvy System Project

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ClinicalTrials.gov Identifier: NCT04060355
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kenneth Hepburn, Emory University

Brief Summary:
The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.

Condition or disease Intervention/treatment Phase
Caregiver Burnout Dementia Behavioral: Savvy program Behavioral: Semi-structured video interviews Not Applicable

Detailed Description:

The number of People Living With Disability (PLWD) in the U.S. will rise from 5.7 million to 14 million by 2050, and the number of family caregivers who maintain these persons in the community will rise proportionately from 15 million at present. Several psychoeducation programs, including Savvy, have successfully ameliorated the adverse effects of caregiving, but these programs are only minimally available and accessible.

The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Developing a Distance Education System to Train Savvy Caregiver Program Interventionists: Extending Access and Capacity in Community-Based Delivery of Evidence-Based Interventions
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Savvy Participants
Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered.
Behavioral: Savvy program
Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.

Experimental: Interventionists
Three recorded semi-structured video interviews will be conducted with each interventionist. One will occur immediately after training; this will focus on their sense of the completeness and adequacy of the training program, including the training methods, videos, and materials, and their perceived readiness to lead the program. Another interview will be done immediately after the conduct of each of the two Savvy programs they lead, asking them to report on their own performance as interventionists, including any adaptation processes in which they might have engaged, and to reflect on ways the training might be improved to strengthen their skills, including for adaptation. In total: 18 interviews.
Behavioral: Semi-structured video interviews
Semi-structured video interviews will assess the preliminary efficacy of programs led by system-trained interventionists in producing anticipated outcomes in caregiver participants - reduced depression and burden and enhanced caregiving mastery. It will also focus on sense of the completeness and adequacy of the training program, including the training methods, videos, and materials

Experimental: Organizational Leaders
Recorded semi-structured video interviews with sponsoring organizations' key contact persons will be conducted immediately after the interventionist training and then after each of two Savvy offerings. The conversation will focus on identifying ways to strengthen and improve the training, certification, and fidelity monitoring system. Information about time and resource costs of the program, caregiver demand, and caregiver recruitment and feedback (3 interviews per organization) will be also collected.
Behavioral: Semi-structured video interviews
Semi-structured video interviews will assess the preliminary efficacy of programs led by system-trained interventionists in producing anticipated outcomes in caregiver participants - reduced depression and burden and enhanced caregiving mastery. It will also focus on sense of the completeness and adequacy of the training program, including the training methods, videos, and materials




Primary Outcome Measures :
  1. Change in Center for Epidemiologic Studies - Depression Scale (CES-D) score [ Time Frame: Baseline, 12 months ]
    The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. It includes 20 items comprising six scales reflecting major facets of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.


Secondary Outcome Measures :
  1. Change in Anxiety score [ Time Frame: Baseline, 12 months ]
    State-Trait Anxiety Inventory scale - 20-item 4-point Likert scale is sensitive to changes in transitory anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

  2. Change in Zarit Burden Inventory (ZBI) score [ Time Frame: Baseline, 12 months ]
    Zarit Burden Inventory (ZBI) score is a 22-item Likert scale. Each item 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 score is obtained by summing all items endorsed. Higher scores indicate greater perceived burden.

  3. Change in Caregiver Pearlin Mastery score [ Time Frame: Baseline, 12 months ]
    The Pearlin Mastery (PM) scale measures the extent to which an individual regards their life chances as being under their personal control rather than fatalistically ruled. Response options: 4-point Likert scale, 1,"Strongly disagree" and 4,"Strongly agree". Items are summed, yielding a range from 7 to 28. Higher scores indicate greater levels of mastery.

  4. Change in Caregiver Assessment of Behavioral Skill score [ Time Frame: Baseline, 12 months ]
    Caregiver Assessment of Behavioral Skill scale is 17-item self-report assessment of behavioral management skills

  5. Change in Revised Memory and Behavior Problem Checklist score [ Time Frame: Baseline, 12 months ]
    Revised Memory and Behavior Problem Checklist is a 22-item Likert scale that assesses patient behaviors and caregiver responses to them. The caregivers' reaction to each behavior, or the extent of distress experienced, are scored. Reactions are assessed by asking how "upsetting" the behavior was on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely). Frequency of behaviors are assessed based on a Likert-scale of 0 to4 (0 = never occurs, 1 = occurs infrequently and not in the last week, 2 = occurred 1-2 times in the last week, 3 = occurred 3-6 times in the last week, and 4 = occurs daily or more often). It yields a summary score - higher scores indicate greater levels of distress.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Organizational Leaders

  1. Able to understand and speak English
  2. Affiliated with an organization serving caregivers for family members living with Alzheimer's disease or related dementias
  3. 18 years or older

Interventionists

  1. Able to understand and speak English
  2. Affiliated with a participating organization
  3. 18 years or older

Caregivers

  1. Able to understand and speak English
  2. Caregiver for a person living with Alzheimer's disease or related dementias (PLWD) who is providing informal care for at least 3 hours a day. PLWD should not be bound for institutional care within the next 6 months.
  3. 18 years or older

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): NCT04060355


Contacts
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Contact: Kenneth Hepburn, MD 404-712-9286 khepbur@emory.edu

Locations
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United States, Georgia
School of Nursing
Atlanta, Georgia, United States, 30322
Contact: Kenneth Hepburn, MD    404-712-9286    khepbur@emory.edu   
Sponsors and Collaborators
Emory University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kenneth Hepburn, MD Emory University
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Responsible Party: Kenneth Hepburn, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04060355    
Other Study ID Numbers: IRB00108423
R01AG061971 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after de-identification
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Immediately following publication, up to 5 years after publication
Access Criteria: Researchers who provide a methodologically sound proposal should submit request to khepbur@emory.edu. Requesters will be required to complete and sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenneth Hepburn, Emory University:
People Living With Disability
PLWD
Caregiver
Interventionist
Distance education
Savvy
Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Behavioral Symptoms