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Completed

NCT Number: NCT04060355

Savvy System Project

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Savvy program

Behavioral

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.

Semi-structured video interviews

Behavioral

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 outcomes

  1. Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score

    Time frame: Baseline, Month 6

    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 outcomes

  1. Change in Anxiety Score

    Time frame: Baseline, Month 6

    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" (0) to "Almost Always" (3)); Range: 0-60. Higher scores indicate greater anxiety.

  2. Change in Zarit Burden Inventory (ZBI) Score

    Time frame: Baseline, Month 6

    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, scored "Never" (0) to "Nearly Always" (4); Range: 0-88. 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, Month 6

    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 Revised Memory and Behavior Problem Checklist Score

    Time frame: Baseline, 6 months

    Revised Memory and Behavior Problem Checklist is a 24-item two-part Likert scale that assesses (Part 1) caregiver reported frequency of patient behaviors and (Part 2) caregiver's responreaction to each behavior, or the extent of distress experienced. The frequency of behaviors is assessed based on a Likert-scale of 0 to (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); Range: 0-96. 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); Range: 0-96. The two parts of the scale yield a summary score - higher scores indicate higher frequency of patient behaviors and greater levels of caregiver distress, respectively.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Developing a Distance Education System to Train Savvy Caregiver Program Interventionists: Extending Access and Capacity in Community-Based Delivery of Evidence-Based Interventions

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2019
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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