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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04421729
Acronym
SoCalSavvy
Enrollment
121
Registered
2020-06-09
Start date
2020-08-25
Completion date
2023-06-30
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burnout, Psychological Distress

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.

Interventions

BEHAVIORALGroup sessions over 3 weeks

Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.

BEHAVIORALGroup sessions over 6 weeks

Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will not have previous knowledge of the respondent's interventional group assignment.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Other

MeasureTime frameDescription
Caregiver Satisfactionup to 7 monthsThis is a measure developed for this specific study to ascertain the study participant's satisfaction with the intervention itself.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026