Clinical trial NCT04421729: SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California
Official title: SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burnout
Psychological Distress
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: up to 7 months
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: up to 7 months
measure: Revised Memory and Behavior Problems Checklist (RMBPC)
timeFrame: up to 7 months
Secondary outcomes:
measure: Caregiver Competence Scales
timeFrame: up to 7 months
measure: Medical Outcomes Study Social Support Survey (MOS)
timeFrame: up to 7 months
measure: Intent to Institutionalize
timeFrame: up to 7 months
measure: Family Members Activities of Daily Living (ADL)
timeFrame: up to 7 months
measure: Family Members Instrumental Activities of Daily Living (IADL)
timeFrame: up to 7 months
Other outcomes:
measure: Caregiver Satisfaction
timeFrame: up to 7 months
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: