Pilot Test of Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Caregiver Self-Efficacy Scale
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Wait-List Control Group
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)
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.
Intervention: LST-LC Education (Behavioral)
Outcomes
Primary Outcomes
Change in Caregiver Self-Efficacy Scale
Time Frame: Baseline to 6 weeks
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.
Secondary Outcomes
- Complex Care Tasks Scale(Baseline to 6 weeks)
- Caregiver Confidence in Medical Sign/Symptom Management (CCSM) scale(Baseline to 6 weeks)