- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04060355
Savvy System Project
Developing a Distance Education System to Train Savvy Caregiver Program Interventionists: Extending Access and Capacity in Community-Based Delivery of Evidence-Based Interventions
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- School of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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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.
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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
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) score
Time Frame: Baseline, 12 months
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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.
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Baseline, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Anxiety score
Time Frame: Baseline, 12 months
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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.
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Baseline, 12 months
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Change in Zarit Burden Inventory (ZBI) score
Time Frame: Baseline, 12 months
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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.
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Baseline, 12 months
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Change in Caregiver Pearlin Mastery score
Time Frame: Baseline, 12 months
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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.
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Baseline, 12 months
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Change in Caregiver Assessment of Behavioral Skill score
Time Frame: Baseline, 12 months
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Caregiver Assessment of Behavioral Skill scale is 17-item self-report assessment of behavioral management skills
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Baseline, 12 months
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Change in Revised Memory and Behavior Problem Checklist score
Time Frame: Baseline, 12 months
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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.
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Baseline, 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Hepburn, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00108423
- R01AG061971 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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UConn HealthEmory UniversityCompletedMental Disorders | Brain Diseases | Central Nervous System Diseases | Nervous System Diseases | Neurocognitive Disorders | Neurodegenerative Diseases | Dementia | Alzheimer Disease | TauopathiesUnited States
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Institut universitaire de cardiologie et de pneumologie...Institut de Cardiologie de MontréalCompletedAortic Valve Stenosis | Aortic Valve Disease | Transcatheter Aortic Valve Replacement | Hemodynamic MeasurementCanada
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Emory UniversityCompletedDepression | Dementia | Alzheimer's DiseaseUnited States
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BiosynUnited States Agency for International Development (USAID); FHI 360Unknown
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Northwestern UniversityEmory UniversityCompletedPrimary Progressive Aphasia | Caregiver BurnoutUnited States
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BiosynUnited States Agency for International Development (USAID); FHI 360Unknown
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Healthcare Center Murska SobotaCompleted