NCT07290387

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
13mo left

Started Apr 2026

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026May 2027

First Submitted

Initial submission to the registry

December 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 17, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

December 15, 2025

Last Update Submit

April 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Caregiver Mastery Score

    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 Outcomes (5)

  • Mean Change in Perceived Stress Scale Score

    Baseline to Three Months Post Intervention

  • Mean Change in Total Zarit Caregiver Burden Scale Score

    Baseline to Three Months Post Intervention

  • Mean Change in Total CES D R Depression Score

    Baseline to Three Months Post Intervention

  • Mean Change in Total Family Caregiver Self Efficacy for Managing Dementia Score

    Baseline to Three Months Post Intervention

  • Mean Total Satisfaction Questionnaire Score Immediately Post Intervention

    Immediately following completion of the seven week intervention

Study Arms (1)

Intervention

EXPERIMENTAL
Behavioral: Tele Savvy for Latino Caregivers

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester School of Nursing

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a single arm Stage 1b behavioral clinical trial using a pre post design. All enrolled participants receive the Tele Savvy for Latino Caregivers intervention and outcomes are assessed at baseline immediately post intervention and three months post intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Nursing

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 18, 2025

Study Start

April 17, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations