Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers

NCT05582473 | Completed

• 1 other identifier: HSC20220579H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia Caregivers

Keywords

Latino caregivers

Outcome Measures

Primary Outcomes (1)

• Change in Caregiver Self-Efficacy Scale

  This is a unidimensional measure, with total score ranging between 1 and 10, with mean (SD) of 6.0 (2.1) in a sample of 158 caregivers (Ritter et al., 2022). Higher scores indicate higher confidence.

  Baseline to 6 weeks

Secondary Outcomes (2)

• Complex Care Tasks Scale

  Baseline to 6 weeks

• Caregiver Confidence in Medical Sign/Symptom Management (CCSM) scale

  Baseline to 6 weeks

Other Outcomes (3)

• Patient Reported Outcomes Measurement Information systems (PROMIS) Global Health Score

  Baseline to 6 weeks

• Lubben Social Network Scale (LSNS-6)

  Baseline to 6 weeks

• Revised Memory and Behavior Checklist

  Baseline to 6 weeks

Study Arms (2)

Wait-List Control Group

NO INTERVENTION

Randomized subjects will wait for a 3 month period before being assigned to the LST-LC education. This group of subjects will act as the control group.

Learning Skills Together-Latino Caregivers (LST-LC)

OTHER

The study team convened a team of health care professionals, including nursing, occupational therapy, speech-language pathology, gerontology, nutrition, and dental hygiene, to develop a community-based education program for family caregivers.

Behavioral: LST-LC Education

Interventions

LST-LC Education BEHAVIORAL

Testing the LST-LC intervention with cultural adaptations integrated through Stage 2 (Adaptation Design). There are 9 modules. Session 1, we describe the principles underlying the program (safety, hygiene, dignity, comfort, and independence), discuss self-care, and introduce a vignette of caring for a person with dementia, designed to generate conversation around the caregiving role. Other modules focus on 1) behavioral and 2) communication challenges in the context of dementia; 3) home safety, transfers, and adaptable medical equipment; 4) managing nutrition needs; 5) swallowing challenges; 6) supporting oral hygiene; 7) dealing with incontinence, including preventing and recognizing urinary tract infections; 8) medication management and 9) managing comorbidities including assessing and managing pain

Learning Skills Together-Latino Caregivers (LST-LC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• aged 18 years or older,
• providing assistance with at least two instrumental activities of daily living or one activity of daily living,
• 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
• not paid to provide care

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Retirement Research Foundation: collaborator

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Study Officials

• Carol L White, PhD, BSN

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant will collect follow-up data and will be blinded to group assignment. Caregivers will be asked not to discuss whether they were in a group program prior to follow-up data collection with the research assistant. The statistician will also be blinded, with group assignment designated using a binary variable in anonymous study data. In order to conduct study activities, other team members will not be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: November 7, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After data collected during the study has been analyzed and published.

Locations

US (1)