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Savvy System Project

Primary Purpose

Caregiver Burnout, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Savvy program
Semi-structured video interviews
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Caregiver Burnout focused on measuring People Living With Disability, PLWD, Caregiver, Interventionist, Distance education, Savvy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Savvy Participants

Interventionists

Organizational Leaders

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Center for Epidemiologic Studies - Depression Scale (CES-D) score
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

Change in Anxiety score
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.
Change in Zarit Burden Inventory (ZBI) score
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.
Change in Caregiver Pearlin Mastery score
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.
Change in Caregiver Assessment of Behavioral Skill score
Caregiver Assessment of Behavioral Skill scale is 17-item self-report assessment of behavioral management skills
Change in Revised Memory and Behavior Problem Checklist score
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.

Full Information

First Posted
August 15, 2019
Last Updated
November 1, 2022
Sponsor
Emory University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04060355
Brief Title
Savvy System Project
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout, Dementia
Keywords
People Living With Disability, PLWD, Caregiver, Interventionist, Distance education, Savvy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Savvy Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Interventionists
Arm Type
Experimental
Arm Description
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.
Arm Title
Organizational Leaders
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Savvy program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Semi-structured video interviews
Intervention Description
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 Measure Information:
Title
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) score
Description
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.
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in Anxiety score
Description
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.
Time Frame
Baseline, 12 months
Title
Change in Zarit Burden Inventory (ZBI) score
Description
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.
Time Frame
Baseline, 12 months
Title
Change in Caregiver Pearlin Mastery score
Description
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.
Time Frame
Baseline, 12 months
Title
Change in Caregiver Assessment of Behavioral Skill score
Description
Caregiver Assessment of Behavioral Skill scale is 17-item self-report assessment of behavioral management skills
Time Frame
Baseline, 12 months
Title
Change in Revised Memory and Behavior Problem Checklist score
Description
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.
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Organizational Leaders Able to understand and speak English Affiliated with an organization serving caregivers for family members living with Alzheimer's disease or related dementias 18 years or older Interventionists Able to understand and speak English Affiliated with a participating organization 18 years or older Caregivers Able to understand and speak English 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. 18 years or older
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Hepburn, MD
Phone
404-712-9286
Email
khepbur@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Hepburn, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Hepburn, MD
Phone
404-712-9286
Email
khepbur@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after de-identification
IPD Sharing Time Frame
Immediately following publication, up to 5 years after publication
IPD Sharing 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.

Learn more about this trial

Savvy System Project

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