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

Psychological Distress Clinical Trial

— SoCalSavvy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421729
• Other study ID #: 5356000538
• Status: Completed
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Psychological Distress

Intervention

Behavioral:
• Group sessions over 3 weeks
Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.
• Group sessions over 6 weeks
Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver Satisfaction	This is a measure developed for this specific study to ascertain the study participant's satisfaction with the intervention itself.	up to 7 months
Primary	Patient Health Questionnaire-9 (PHQ-9)	caregiver depressive symptoms	up to 7 months
Primary	Generalized Anxiety Disorder (GAD-7)	caregiver anxiety symptoms	up to 7 months
Primary	Revised Memory and Behavior Problems Checklist (RMBPC)	caregiver reactivity to family member's memory/behavior problems	up to 7 months
Secondary	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
Secondary	Medical Outcomes Study Social Support Survey (MOS)	Measures caregiver social support using the MOS scale	up to 7 months
Secondary	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
Secondary	Family Members Activities of Daily Living (ADL)	measures family member's activities of daily living using the Katz ADL scale	up to 7 months
Secondary	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