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

Dementia Caregivers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05582473
• Other study ID #: HSC20220579H
• Status: Completed
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: October 13, 2023

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 13, 2023
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Dementia Caregivers

Intervention

Behavioral:
• LST-LC Education
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

Locations

Country	Name	City	State
United States	UT Health San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Retirement Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Reported Outcomes Measurement Information systems (PROMIS) Global Health Score	For this scale, each of the each of the individual 10 items can be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health, and general perceptions of health (ranging from 1 to 5) with higher scores indicating better global health. There are also two-subscales, Physical Health (PH) and Mental Health (MH) that can be converted to standardized T-score values, with a T-score of 50 which represents the mean of the general population and higher scores indicate better physical and mental health.	Baseline to 6 weeks
Other	Lubben Social Network Scale (LSNS-6)	A six item, self reported scale to assess social isolation in older adults by measureing perceived social support received by family and friends. The total score is calculated by finding the sum of the all items, with the score ranges between 0 and 30, with a higher score indicating more social engagement.	Baseline to 6 weeks
Other	Revised Memory and Behavior Checklist	A 24-item scale used to measure behavioral challenges experienced by the person living with dementia, from the perspective of the caregiver. The possible range for this scale is 0-96, the mean frequency (SD) of behaviors is 34 (16.6) and the mean reaction (SD) is 22.7 (15.6). A lower score indicates better coping skills.	Baseline to 6 weeks
Primary	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	Complex Care Tasks Scale	A scale developed by the study team with total score ranging from 14 to 70. Items are summed and averaged. In our pilot study with 35 caregivers, the mean (SD) was 3.7 (0.8) (Meyer et al., 2022). Higher scores indicate higher confidence.	Baseline to 6 weeks
Secondary	Caregiver Confidence in Medical Sign/Symptom Management (CCSM) scale	A 25 item scale which evaluates the efforts to support family caregivers of people with dementia in their daily medical management responsibilities requires a measure of caregiver self-efficacy (confidence).The total score on this scale ranges from 25 to 125, with items summed and averaged with a mean (SD) of 3.8 (0.6) in a sample of 194 caregivers (Zimmerman et al., 2018). Higher scores indicate higher confidence.	Baseline to 6 weeks