Clinical trial NCT05582473: Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers
Official title: Pilot Test of Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Caregivers
Keywords: Latino caregivers
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Retirement Research Foundation
First posted: 2022-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized wait-list control group design with blinded outcomes assessment to examine the effectiveness of LST-LC on caregiver confidence and self-efficacy in performing complex care tasks. This design has the advantage of making enrollment more feasible as participants may find the intervention highly desirable and will eventually receive it. Yet, the design provides a randomized comparison with a non-intervention control group. Participants will be individually randomized 1:1 to an immediate intervention group (IG) and a wait-list (delayed) control group (WLC).
Primary purpose: OTHER

Brief summary: The overall goal of this study is to culturally adapt and test the effectiveness of Learning Skills Together (LST) in improving self-efficacy among Latino family caregivers. To address this overall goal, the study team propose the following aims: i) culturally adapt the LST intervention for Latino caregivers using a community-engaged approach; and ii) examine the effect of the LST intervention on Latino caregiver self-efficacy, depression, and well-being using a randomized wait-list control group.

Detailed description: The study team will use a randomized wait-list control group design with blinded outcomes assessment to examine the effectiveness of LST-LC on caregiver confidence and self-efficacy in performing complex care tasks. This design has the advantage of making enrollment more feasible as participants may find the intervention highly desirable and will eventually receive it. Yet, the design provides a randomized comparison with a non-intervention control group. Participants will be individually randomized 1:1 to an immediate intervention group (IG) and a wait-list (delayed) control group (WLC).

Eligibility criteria: Inclusion Criteria:

1. a family member to an individual living with AD/ADRD (Alzheimers Disease/Alzheimers Disease and related dementias) who has received a diagnosis from a physician,
2. aged 18 years or older,
3. providing assistance with at least two instrumental activities of daily living or one activity of daily living,
4. providing care to a person with dementia in mid-stage as defined by a score between 4 and 6 on the Global Deterioration Scale (GDS), and
5. not paid to provide care

Exclusion Criteria:

1. are unable to read and speak English or Spanish,
2. previously participated in LST, and/or
3. have plans to place the care recipient in a skilled nursing facility within the next 6 months (i.e., study duration).
4. Participants must have a Patient Health Questionnaire (PHQ-9) score of less than 15, the threshold for moderately severe depression
5. Participants with severe depression

Primary outcomes:
measure: Change in Caregiver Self-Efficacy Scale
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Complex Care Tasks Scale
timeFrame: Baseline to 6 weeks
measure: Caregiver Confidence in Medical Sign/Symptom Management (CCSM) scale
timeFrame: Baseline to 6 weeks
Other outcomes:
measure: Patient Reported Outcomes Measurement Information systems (PROMIS) Global Health Score
timeFrame: Baseline to 6 weeks
measure: Lubben Social Network Scale (LSNS-6)
timeFrame: Baseline to 6 weeks
measure: Revised Memory and Behavior Checklist
timeFrame: Baseline to 6 weeks
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Carol L White, PhD, BSN
role: PRINCIPAL_INVESTIGATOR
References: