Savvy System Project

NCT04060355 | Completed Results DMC

• 2 other identifiers: IRB00108423R01AG061971
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burnout; Dementia

Keywords

People Living With Disability; PLWD; Caregiver; Interventionist; Distance education; Savvy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 6

Secondary Outcomes (4)

• Change in Anxiety Score

  Baseline, Month 6

• Change in Zarit Burden Inventory (ZBI) Score

  Baseline, Month 6

• Change in Caregiver Pearlin Mastery Score

  Baseline, Month 6

• Change in Revised Memory and Behavior Problem Checklist Score

  Baseline, 6 months

Study Arms (3)

Savvy Participants

EXPERIMENTAL

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

Interventionists

EXPERIMENTAL

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 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.

Behavioral: Semi-structured video interviews

Organizational Leaders

EXPERIMENTAL

Recorded semi-structured video interviews with sponsoring organizations' key contact persons will be conducted immediately after the interventionist training and then after each of the 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 will be also collected.

Behavioral: Semi-structured video interviews

Interventions

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.

Savvy Participants

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

Interventionists; Organizational Leaders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Interventionists
• Able to understand and speak English
• Affiliated with a participating organization
• 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.
• years or older

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

School of Nursing

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The study was not conducted as a two-armed trial as originally planned; therefore, there is no second group for data reporting. Most of the project occurred during the COVID pandemic, especially the caregiver component. Collaborating agencies were unwilling to suggest that clients volunteer for a trial requiring a 4-month wait for the Savvy Caregiver program. Due to recruitment challenges, the trial was run as a one-arm, collecting data at baseline and 6 months instead.

Results Point of Contact

• Title: Kenneth Hepburn, PhD
• Organization: Emory University, School of Nursing

khepbur@emory.edu

404-712-9286

Study Officials

• Kenneth Hepburn, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: August 4, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 30, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)