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Clinical Trials/NCT04060355
NCT04060355CompletedNot Applicable

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

Emory University1 site in 1 country120 target enrollmentStarted: August 4, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Intervention: Savvy program (Behavioral)

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.

Intervention: Semi-structured video interviews (Behavioral)

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.

Intervention: Semi-structured video interviews (Behavioral)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kenneth Hepburn

Principal Investigator

Emory University

Study Sites (1)

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