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NCT Number: NCT04421729

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

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.

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Key information

Conditions

Caregiver Burnout Behavior Behavioral Symptoms Caregiver Burden Psychological Distress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90015, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group sessions over 3 weeks

Behavioral

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

Group sessions over 6 weeks

Behavioral

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

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: up to 7 months

    caregiver depressive symptoms

  2. Generalized Anxiety Disorder (GAD-7)

    Time frame: up to 7 months

    caregiver anxiety symptoms

  3. Revised Memory and Behavior Problems Checklist (RMBPC)

    Time frame: up to 7 months

    caregiver reactivity to family member's memory/behavior problems

Secondary outcomes

  1. Caregiver Competence Scales

    Time frame: up to 7 months

    measures caregiver skills, mastery, competence, management of the situation based on the Caregiver Competence, Management and Meaning Scales

  2. Medical Outcomes Study Social Support Survey (MOS)

    Time frame: up to 7 months

    Measures caregiver social support using the MOS scale

  3. Intent to Institutionalize

    Time frame: up to 7 months

    TA one-item measure that assesses if the caregiver intends to institutionalize the family member in the next 6 months

  4. Family Members Activities of Daily Living (ADL)

    Time frame: up to 7 months

    measures family member's activities of daily living using the Katz ADL scale

  5. Family Members Instrumental Activities of Daily Living (IADL)

    Time frame: up to 7 months

    measures family member's activities of daily living using the Lawton IDL scale

Other outcomes

  1. Caregiver Satisfaction

    Time frame: up to 7 months

    This is a measure developed for this specific study to ascertain the study participant's satisfaction with the intervention itself.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Acronym: SoCalSavvy

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2020
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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