Clinical trial NCT04060355: 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
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burnout
Dementia
Keywords: People Living With Disability
PLWD
Caregiver
Interventionist
Distance education
Savvy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-08-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change in Anxiety Score
timeFrame: Baseline, Month 6
measure: Change in Zarit Burden Inventory (ZBI) Score
timeFrame: Baseline, Month 6
measure: Change in Caregiver Pearlin Mastery Score
timeFrame: Baseline, Month 6
measure: Change in Revised Memory and Behavior Problem Checklist Score
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: School of Nursing
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Hepburn, PhD
role: PRINCIPAL_INVESTIGATOR
References: