SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California (SoCalSavvy)
Primary Purpose
Caregiver Burnout, Psychological Distress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group sessions over 3 weeks
Group sessions over 6 weeks
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burnout
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
Sites / Locations
- University of Southern CaliforniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Savvy Caregiver Program
Savvy Express
Arm Description
Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
Outcomes
Primary Outcome Measures
Patient Health Questionnaire-9 (PHQ-9)
caregiver depressive symptoms
Generalized Anxiety Disorder (GAD-7)
caregiver anxiety symptoms
Revised Memory and Behavior Problems Checklist (RMBPC)
caregiver reactivity to family member's memory/behavior problems
Secondary Outcome Measures
Caregiver Competence Scales
measures caregiver skills, mastery, competence, management of the situation based on the Caregiver Competence, Management and Meaning Scales
Medical Outcomes Study Social Support Survey (MOS)
Measures caregiver social support using the MOS scale
Intent to Institutionalize
TA one-item measure that assesses if the caregiver intends to institutionalize the family member in the next 6 months
Family Members Activities of Daily Living (ADL)
measures family member's activities of daily living using the Katz ADL scale
Family Members Instrumental Activities of Daily Living (IADL)
measures family member's activities of daily living using the Lawton IDL scale
Full Information
NCT ID
NCT04421729
First Posted
June 2, 2020
Last Updated
November 1, 2022
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT04421729
Brief Title
SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California
Acronym
SoCalSavvy
Official Title
SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout, Psychological Distress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will not have previous knowledge of the respondent's interventional group assignment.
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Savvy Caregiver Program
Arm Type
Active Comparator
Arm Description
Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
Arm Title
Savvy Express
Arm Type
Active Comparator
Arm Description
Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
Intervention Type
Behavioral
Intervention Name(s)
Group sessions over 3 weeks
Intervention Description
Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.
Intervention Type
Behavioral
Intervention Name(s)
Group sessions over 6 weeks
Intervention Description
Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
caregiver depressive symptoms
Time Frame
up to 7 months
Title
Generalized Anxiety Disorder (GAD-7)
Description
caregiver anxiety symptoms
Time Frame
up to 7 months
Title
Revised Memory and Behavior Problems Checklist (RMBPC)
Description
caregiver reactivity to family member's memory/behavior problems
Time Frame
up to 7 months
Secondary Outcome Measure Information:
Title
Caregiver Competence Scales
Description
measures caregiver skills, mastery, competence, management of the situation based on the Caregiver Competence, Management and Meaning Scales
Time Frame
up to 7 months
Title
Medical Outcomes Study Social Support Survey (MOS)
Description
Measures caregiver social support using the MOS scale
Time Frame
up to 7 months
Title
Intent to Institutionalize
Description
TA one-item measure that assesses if the caregiver intends to institutionalize the family member in the next 6 months
Time Frame
up to 7 months
Title
Family Members Activities of Daily Living (ADL)
Description
measures family member's activities of daily living using the Katz ADL scale
Time Frame
up to 7 months
Title
Family Members Instrumental Activities of Daily Living (IADL)
Description
measures family member's activities of daily living using the Lawton IDL scale
Time Frame
up to 7 months
Other Pre-specified Outcome Measures:
Title
Caregiver Satisfaction
Description
This is a measure developed for this specific study to ascertain the study participant's satisfaction with the intervention itself.
Time Frame
up to 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria P Aranda
Phone
2137401887
Email
aranda@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Aguilar
Phone
2137401887
Email
iaguilar@usc.edu
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria P Aranda, PhD
Phone
213-740-1887
Email
aranda@usc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California
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