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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Caregiver Burnout, Psychological Distress

Intervention / Treatment
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* Behavioral: Group sessions over 3 weeks
* Behavioral: Group sessions over 6 weeks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Savvy Caregiver Program<br>Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources. | Behavioral: Group sessions over 6 weeks<br>* Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.<br>|
| Active Comparator: Savvy Express<br>Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources. | Behavioral: Group sessions over 3 weeks<br>* Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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