- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290387
Tele-Savvy for Latino Caregivers
May 13, 2026 updated by: Maria Quinones, University of Rochester
Latino caregivers of individuals with Alzheimer's disease and related dementias experience high levels of stress burden and depressive symptoms and are underrepresented in caregiver intervention research.
Tele Savvy is an evidence based caregiver education program that focuses on developing caregiver mastery skills.
This study aims to culturally adapt the Tele Savvy intervention for Latino caregivers and evaluate its preliminary efficacy in a Stage 1b single arm clinical trial.
The intervention is delivered remotely and includes weekly group sessions and asynchronous instructional videos.
Primary outcomes focus on caregiver mastery with secondary outcomes including stress burden depressive symptoms and self efficacy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maria Quiñones, PhD
- Phone Number: (585) 276-3903
- Email: Maria_Quinones@URMC.Rochester.edu
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- Recruiting
- University of Rochester School of Nursing
-
Contact:
- Maria Quiñones-Cordero, PhD
- Phone Number: 5852763903
- Email: maria_quinones@urmc.rochester.edu
-
Contact:
-
Principal Investigator:
- Maria Quiñones-Cordero, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Identify as Hispanic or Latino
- Age 18 years or older
- Spanish speaking and able to read and write in Spanish
- Provide at least four hours per week of care to a community dwelling loved one with Alzheimer's disease or related dementias
- Have access to an electronic device and internet
- Willing to participate in study interviews and intervention sessions
Exclusion Criteria:
- Physical or sensory conditions preventing use of a computer tablet or smartphone
- Planning to move the care recipient to an institutional setting within six months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
Tele Savvy for Latino Caregivers is a culturally adapted seven week caregiver education and support program delivered remotely.
Participants attend weekly ninety minute group sessions via videoconference and receive two to three asynchronous instructional videos per week.
The intervention focuses on developing caregiver mastery skills including caregiving competence confidence and stress management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in Caregiver Mastery Score
Time Frame: Baseline to three months post intervention completion
|
Caregiver mastery is measured using two Pearlin Caregivers' Stress subscales: Caregiving Competence and Confidence and Management of Situation.
Each subscale consists of four Likert type items.
Item responses are scored according to published scoring instructions and summed to produce a total caregiver mastery score for each participant at each assessment time point.
The outcome is defined as the mean change in the total caregiver mastery score from baseline to three months post intervention across participants.
|
Baseline to three months post intervention completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in Perceived Stress Scale Score
Time Frame: Baseline to Three Months Post Intervention
|
Perceived stress is measured using the 10 item Perceived Stress Scale.
Each item is scored on a Likert type scale according to standard scoring procedures, with designated items reverse scored.
Item scores are summed to generate a total Perceived Stress Scale score for each participant at each assessment time point.
The outcome is defined as the mean change in the total Perceived Stress Scale score from baseline to three months post intervention.
|
Baseline to Three Months Post Intervention
|
|
Mean Change in Total Zarit Caregiver Burden Scale Score
Time Frame: Baseline to Three Months Post Intervention
|
Caregiver burden is measured using the Zarit Caregiver Burden Scale.
Individual item responses are scored and summed to produce a total Zarit Burden score for each participant at each assessment time point.
The outcome is defined as the mean change in the total Zarit Caregiver Burden Scale score from baseline to three months post intervention.
|
Baseline to Three Months Post Intervention
|
|
Mean Change in Total CES D R Depression Score
Time Frame: Baseline to Three Months Post Intervention
|
Depressive symptoms are measured using the Center for Epidemiologic Studies Depression Scale Revised.
Item responses are scored according to standard scoring procedures and summed to generate a total CES D R score for each participant at each assessment time point.
The outcome is defined as the mean change in the total CES D R score from baseline to three months post intervention.
|
Baseline to Three Months Post Intervention
|
|
Mean Change in Total Family Caregiver Self Efficacy for Managing Dementia Score
Time Frame: Baseline to Three Months Post Intervention
|
Caregiver self efficacy is measured using the Family Caregiver Self Efficacy for Managing Dementia questionnaire.
Item responses are scored and summed to generate a total self efficacy score for each participant at each assessment time point.
The outcome is defined as the mean change in the total caregiver self efficacy score from baseline to three months post intervention.
|
Baseline to Three Months Post Intervention
|
|
Mean Total Satisfaction Questionnaire Score Immediately Post Intervention
Time Frame: Immediately following completion of the seven week intervention
|
Participant satisfaction is measured using a satisfaction questionnaire administered immediately after intervention completion.
Item responses are scored and summed to produce a total satisfaction score for each participant.
The outcome is defined as the mean total satisfaction questionnaire score across participants.
|
Immediately following completion of the seven week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
December 15, 2025
First Submitted That Met QC Criteria
December 15, 2025
First Posted (Actual)
December 18, 2025
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00009037
- 5P30AG064200 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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