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

NCT ID: NCT04421729

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2023-06-30

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.

Conditions

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Caregiver Burnout Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

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

Study Groups

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Savvy Caregiver Program

Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.

Group Type ACTIVE_COMPARATOR

Group sessions over 6 weeks

Intervention Type BEHAVIORAL

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

Savvy Express

Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.

Group Type ACTIVE_COMPARATOR

Group sessions over 3 weeks

Intervention Type BEHAVIORAL

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

Interventions

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Group sessions over 3 weeks

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

Intervention Type BEHAVIORAL

Group sessions over 6 weeks

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Maria P. Aranda

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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5356000538

Identifier Type: -

Identifier Source: org_study_id

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