Dementia CaregiversNCT05582473
Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers
A study testing LST-LC Education in people with Dementia Caregivers, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Caregivers
- What is being tested?
- LST-LC Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 13 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Test of Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers
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.
Read the 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).
- Conditions
- Dementia Caregivers
- Being tested
- LST-LC Education
- Keywords
- Latino caregivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LST-LC EducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Wait-List Control Group | No intervention | 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) | Other | 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. Receives: Behavioral: LST-LC Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start7 Nov 2022
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Retirement Research Foundation
- Responsible party
- Sponsor
- Investigators
- Carol L White, PhD, BSN, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582473
- Sponsor's protocol ID
- HSC20220579H
- Status last verified
- Mar 2024
- First submitted
- 12 Oct 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
White CL, Choi BY, Delgado RE, Neidre DB, Peacock KS, Luy LP, Fernandez R, Epps F, Song L. Pilot Test of Aprendiendo Juntos/Learning Together Demonstrates Improved Self-Efficacy for Providing Care Among Latino Family Caregivers of Persons Living With Dementia. West J Nurs Res. 2025 Nov;47(11):1095-1107. doi: 10.1177/01939459251359209. Epub 2025 Aug 4.
PubMed 40757954
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers
- ClinicalTrials.gov ID
- NCT05582473
- Acronym / sponsor ID
- HSC20220579H
- Conditions
- Dementia Caregivers
- Keywords
- Latino caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Retirement Research Foundation
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Wait-List Control Group | No intervention | –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) | Other | Behavioral: LST-LC EducationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LST-LC EducationTesting 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 | Behavioural | Learning Skills Together-Latino Caregivers (LST-LC) |
Primary outcome
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.
2 secondary outcomes
Complex Care Tasks Scale
Time frame: Baseline to 6 weeks
Caregiver Confidence in Medical Sign/Symptom Management (CCSM) scale
Time frame: Baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 40757954White CL, Choi BY, Delgado RE, Neidre DB, Peacock KS, Luy LP, Fernandez R, Epps F, Song L. Pilot Test of Aprendiendo Juntos/Learning Together Demonstrates Improved Self-Efficacy for Providing Care Among Latino Family Caregivers of Persons Living With Dementia. West J Nurs Res. 2025 Nov;47(11):1095-1107. doi: 10.1177/01939459251359209. Epub 2025 Aug 4.
- Individual participant dataSharing planned: Yes. 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
Related trials for Dementia Caregivers
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Recruiting
The WeACT Program for Family Caregivers of People Living With Dementia
Depression, Caregivers
Not yet recruiting
VICA: A Virtual Care Assistant for Dementia Caregivers
Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
Recruiting
Leveraging Interventions for Caregiver Growth, Health, Training, Empowerment and Navigation: Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain
Elevated Caregiver Strain, Dementia Caregiver
Not yet recruitingPhase 2
Peer Support for Family Caregivers of Older Adults Living With Dementia
Caregiver Burden, Caregiver Burnout
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol L White, PhD, BSN principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LST-LC Education in people with Dementia Caregivers, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Caregiver Self-Efficacy Scale (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024; AzTrials last refreshed its copy on 28 Oct 2026.