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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Dementia Caregivers

Intervention / Treatment
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* Behavioral: LST-LC Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait-List Control Group<br>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. | |
| Other: Learning Skills Together-Latino Caregivers (LST-LC)<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latino caregivers