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

Primary Purpose

Dementia Caregivers

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LST-LC Education

About this trial

This is an interventional other trial for Dementia Caregivers focused on measuring Latino caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UT Health San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Wait-List Control Group

Learning Skills Together-Latino Caregivers (LST-LC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05582473

First Posted

October 12, 2022

Last Updated

October 4, 2023

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Retirement Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05582473

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 7, 2022 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Retirement Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia Caregivers

Keywords

Latino caregivers

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

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.

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Wait-List Control Group

Arm Type

No Intervention

Arm Description

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.

Arm Title

Learning Skills Together-Latino Caregivers (LST-LC)

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

LST-LC Education

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Caregiver Self-Efficacy Scale

Description

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.

Time Frame

Baseline to 6 weeks

Secondary Outcome Measure Information:

Title

Complex Care Tasks Scale

Description

Time Frame

Baseline to 6 weeks

Title

Caregiver Confidence in Medical Sign/Symptom Management (CCSM) scale

Description

Time Frame

Baseline to 6 weeks

Other Pre-specified Outcome Measures:

Title

Patient Reported Outcomes Measurement Information systems (PROMIS) Global Health Score

Description

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.

Time Frame

Baseline to 6 weeks

Title

Lubben Social Network Scale (LSNS-6)

Description

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.

Time Frame

Baseline to 6 weeks

Title

Revised Memory and Behavior Checklist

Description

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.

Time Frame

Baseline to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carole L White, PhD, BSN

Phone

210 380 5764

whitec2@uthscsa.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Daria B Neidre, PhD

Phone

210 567 5968

neidre@uthscsa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol L White, PhD, BSN

Organizational Affiliation

University of Texas Health Science Center San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Health San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carole White, PhD, RN

Phone

210-567-5831

whitec2@uthscsa.edu

First Name & Middle Initial & Last Name & Degree

Daria Neidre, PhD

Phone

210-567-5968

neidre@uthscsa.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The community-engaged approach used to adapt and test the intervention will also support dissemination. The investigators will work closely with community-based organizations such as the local Area Agency on Aging and Alzheimer's Association for recruitment and , will provide quarterly updates to community partners on progress through the Family Caregiver Coalition and Caring for the Caregiver newsletters. The investigators will disseminate the results of the study through community forums, as well as publication in peer-reviewed journals and presentations at professional meetings. The target audience for dissemination is community organizations who support family caregivers. With that in mind, we will target the American Society on Aging for presenting the results of the study. Information will be shared as a publication in a peer reviewed scientific journal

IPD Sharing Time Frame

After data collected during the study has been analyzed and published.

Learn more about this trial

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

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