NCT04421729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2.8 years

First QC Date

June 2, 2020

Last Update Submit

May 31, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Caregiver Competence Scales

    up to 7 months

  • Medical Outcomes Study Social Support Survey (MOS)

    up to 7 months

  • Intent to Institutionalize

    up to 7 months

  • Family Members Activities of Daily Living (ADL)

    up to 7 months

  • Family Members Instrumental Activities of Daily Living (IADL)

    up to 7 months

Other Outcomes (1)

  • Caregiver Satisfaction

    up to 7 months

Study Arms (2)

Savvy Caregiver Program

ACTIVE COMPARATOR

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

Behavioral: Group sessions over 6 weeks

Savvy Express

ACTIVE COMPARATOR

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

Behavioral: Group sessions over 3 weeks

Interventions

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

Savvy Express

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

Savvy Caregiver Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English- speaking women and men age 18 or older who care for or provide assistance to someone with dementia

You may not qualify if:

  • Caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90015, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will not have previous knowledge of the respondent's interventional group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 9, 2020

Study Start

August 25, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations