Demonstrating the Efficacy of a Spanish-Language Program for Latino Dementia Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skill-building classes, Wait list control group.
- Who it may be relevant to
- Registry conditions: Caregiver Burden of People With Dementia. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Demonstrating the Efficacy of "Unidos en el Cuidado" (United in Caring): A Spanish-Language Program for Latino Caregivers of Persons Living With Dementia
Overview
The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.
Detailed description
The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.
Based on a wait list trial design, and 4 observation points (baseline, post-intervention, 3-month and 6-month follow-ups), the investigators propose to demonstrate the efficacy of this new intervention (Aim 1), and evaluate for potential moderating conditions across subgroups (Aim 2; age, gender, educational level, etc.). Based on this quantitative component, the investigators will answer the following two aims:
Aim #1. (Efficacy) Compared to a waitlist control group, is Unidos efficacious with regards to primary outcomes-PHQ-9 depression symptoms, RMBPC reactivity to memory and behavior problems, anxiety symptoms, and secondary outcomes-caregiver mastery, competence, and meaning over time?
Aim #2: (Moderators). Do moderating conditions exist such that the intervention is more or less efficacious for subgroups based on age, gender, PLWD functioning?
Qualitative component: After class completion, the investigators will draw from 40-50 focus group participants to elucidate the satisfaction and acceptability of the program. Both Unidos and wait list control participants will be randomly selected for focus group interviews which will be guided by open-ended inquiries around the nuanced, in-depth perspectives of program participation, acceptability, and recommendations (Aim 3).
Aim #3: (Experience/Satisfaction). Will qualitative reports from focus groups signal satisfaction, nuanced differences with respect to the nature, structure, cultural/ language considerations of Unidos, and recommendations?
Based on the scientific team and community partner's established expertise in dementia care, caregiving services, and underrepresented groups, the project is well positioned to address the linguistic and cultural preferences and needs of diverse Californians and the providers that serve them.
Interventions
- Other Skill-building classes
Unidos en el Cuidado is a manualized, multi-family group intervention provided at no cost vis-à-vis videoconferencing or on-site by trained facilitators Sessions are held weekly for 1.5 hours. Class components include caregiver role identity; skills-building; knowledge attainment; attitudinal changes; resource-sharing; practice/role-plays; homework; videos, handouts. Classes will be provided online with some classes offered in the community, if available - Other Wait list control group
The intervention is the same; the wait period is longer to receive the intervention described in Group A.
Primary outcome measures
- Depressive symptoms [Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline]
- Presence and reaction to memory and behavior problems shown by person with dementia [Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline]
- Anxiety symptoms [Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline]
Secondary outcome measures (3)
- Caregiver Mastery [Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline]
- Caregiver Competence [Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline]
- Caregiver Meaning [Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline]
Eligibility criteria
Inclusion criteria
- identifies with being Hispanic or Latino descent
- speaks and reads Spanish
- dementia family caregivers living (or recently lived) in California or whose care recipient lives (or recently lived) in California
- who identify as women, men, or non-binary,
- age 18 years or older
Exclusion criteria
- Severe sensory or physical conditions that interfere with ongoing participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Southern California — Los Angeles
Publications
- Griffiths PC, Kovaleva M, Higgins M, Langston AH, Hepburn K. Tele-Savvy: An Online Program for Dementia Caregivers. Am J Alzheimers Dis Other Demen. 2018 Aug;33(5):269-276. doi: 10.1177/1533317518755331. Epub 2018 Mar 16. PMID 29544342
Identifiers
NCT: NCT06747637 · AWD-00008709