SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California
SoCalSavvy
1 other identifier
interventional
121
1 country
1
Brief Summary
The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJune 3, 2024
May 1, 2024
2.8 years
June 2, 2020
May 31, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Patient Health Questionnaire-9 (PHQ-9)
caregiver depressive symptoms
up to 7 months
Generalized Anxiety Disorder (GAD-7)
caregiver anxiety symptoms
up to 7 months
Revised Memory and Behavior Problems Checklist (RMBPC)
caregiver reactivity to family member's memory/behavior problems
up to 7 months
Secondary Outcomes (5)
Caregiver Competence Scales
up to 7 months
Medical Outcomes Study Social Support Survey (MOS)
up to 7 months
Intent to Institutionalize
up to 7 months
Family Members Activities of Daily Living (ADL)
up to 7 months
Family Members Instrumental Activities of Daily Living (IADL)
up to 7 months
Other Outcomes (1)
Caregiver Satisfaction
up to 7 months
Study Arms (2)
Savvy Caregiver Program
ACTIVE COMPARATORSavvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
Savvy Express
ACTIVE COMPARATORSavvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
Interventions
Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.
Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.
Eligibility Criteria
You may qualify if:
- English- speaking women and men age 18 or older who care for or provide assistance to someone with dementia
You may not qualify if:
- Caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90015, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor will not have previous knowledge of the respondent's interventional group assignment.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 9, 2020
Study Start
August 25, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
June 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share