SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California

Not Applicable

Completed

• Conditions: Caregiver Burnout; Psychological Distress

• Registration Number: NCT04421729
• Lead Sponsor: University of Southern California

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.

Detailed Description

A number of epidemiological studies, systematic reviews, and consensus reports highlight the importance of non-pharmacological, sociobehavioural interventions to address the health, psychological, and social effects of caregiving for persons living with dementia, and the need for tangible information and resources.

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. It is hypothesized that no differences (comparable effects) between the programs in their efficacy/effectiveness and moderating conditions.

Focus groups (\~25 participants) will be conducted to ascertain program acceptability and satisfaction.

The analyses will include a multiple linear mixed-effects modeling for our trial outcomes, and thematic analyses for our focus group interview data.

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-08-25
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• English- speaking women and men age 18 or older who care for or provide assistance to someone with dementia

Exclusion Criteria

• Caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Revised Memory and Behavior Problems Checklist (RMBPC)	up to 7 months	caregiver reactivity to family member's memory/behavior problems
Patient Health Questionnaire-9 (PHQ-9)	up to 7 months	caregiver depressive symptoms
Generalized Anxiety Disorder (GAD-7)	up to 7 months	caregiver anxiety symptoms

Secondary Outcome Measures

Name	Time	Method
Medical Outcomes Study Social Support Survey (MOS)	up to 7 months	Measures caregiver social support using the MOS scale
Intent to Institutionalize	up to 7 months	TA one-item measure that assesses if the caregiver intends to institutionalize the family member in the next 6 months
Caregiver Competence Scales	up to 7 months	measures caregiver skills, mastery, competence, management of the situation based on the Caregiver Competence, Management and Meaning Scales
Family Members Activities of Daily Living (ADL)	up to 7 months	measures family member's activities of daily living using the Katz ADL scale
Family Members Instrumental Activities of Daily Living (IADL)	up to 7 months	measures family member's activities of daily living using the Lawton IDL scale

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States