A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)

Caregivers of People With Dementia Clinical Trial

Official title:

A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394388
• Other study ID #: 24-0291-01
• Secondary ID: 5P30AG064103
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: June 2024
• Source: University of Rochester
• Contact: Julian Montoro Rodriguez
• Phone: 9092049061
• Email: jmontoro[@]charlotte.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test the effectiveness of a behavioral intervention called Cuidando Juntos in Latino caregivers of people with dementia. The study will determine if the intervention improves the caregiver's loneliness, stress, burden, and depression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 39 Years and older

Eligibility

Inclusion Criteria:

• Spanish speaking

• Latino caregivers are those who identify as the primary caregivers of a person with dementia, with whom they co-reside or live close by.

• must have an email address and access to the internet

• Caregivers should report at least a moderate level of stress

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Caregivers of People With Dementia
• Dementia

Intervention

Behavioral:
• Cuidando juntos
Caregiver TLC program will be culturally tailored by including a focus on addressing cultural values to promote social connectedness and translated into Spanish (Cuidando Juntos). Cuidando Juntos consists of 8 modules: stress management; behavioral activation; building resilience; building self-care skills; managing difficult emotions; reducing isolation; and two on understanding and responding to difficult behaviors of the PLWD.

Locations

Country	Name	City	State
United States	University of North Carolina, Charlotte	Charlotte	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Aging (NIA), University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in PHQ-9 to assess depressive symptoms	The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).The scale ranges from 0-27, with higher scores indicating higher depression.	Baseline to six weeks
Primary	Mean change in Perceived Stress Scale	The perceived stress scale is a 4-item questionnaire, with a score range of 0 to 16. Higher scores are correlated with more stress.	Baseline to six weeks
Primary	Mean change in Zarit Caregiver Burden 6-item version	The Zarit caregiver burden 6-item version is a self-administered instrument that ranges from 0-88. Higher scores indicate more burden.	Baseline to six weeks
Primary	Mean change in Caregiver Self-Efficacy Scale (CSES-8)	The caregiver self-efficacy scale is an 8-item scale developed to reflect components of typical caregiver support interventions that range from 0 to 8. Higher scores indicate being more confident.	Baseline to six weeks
Primary	Mean change in UCLA Loneliness Scale	The UCLA loneliness scale is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The scale measures from 0 to 60; higher scores indicate more loneliness.	Baseline to six weeks
Primary	Mean change in Social Network Scale	The Social network scale is a self-report measure of social engagement that includes engagement with family and friends.The Short version, a 6-item scale, is used. The scale ranges from 0 to 35; higher scores indicate better outcome.	Baseline to six weeks