Alzheimer DiseaseNCT07290387
Tele-Savvy for Latino Caregivers
A study testing Tele Savvy for Latino Caregivers in people with Alzheimer Disease and Dementia, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Caregiver Stress
- What is being tested?
- Tele Savvy for Latino Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester School of Nursing
Rochester, New York, 14642
Maria Quiñones-Cordero, PhD, 5852763903, maria_quinones@urmc.rochester.edu
maria_quinones@urmc.rochester.edu
About this study
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.
- Conditions
- Alzheimer Disease, Dementia, Caregiver Stress
- Being tested
- Tele Savvy for Latino Caregivers
- Medical subject headings
- Alzheimer Disease, Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele Savvy for Latino CaregiversBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Tele Savvy for Latino Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to three months post intervention completion
Secondary outcomes (5)
Mean Change in Perceived Stress Scale Score
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.
Measured: Baseline to Three Months Post Intervention
Mean Change in Total Zarit Caregiver Burden Scale Score
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.
Measured: Baseline to Three Months Post Intervention
Mean Change in Total CES D R Depression Score
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.
Measured: Baseline to Three Months Post Intervention
Mean Change in Total Family Caregiver Self Efficacy for Managing Dementia Score
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.
Measured: Baseline to Three Months Post Intervention
Mean Total Satisfaction Questionnaire Score Immediately Post 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.
Measured: Immediately following completion of the seven week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start17 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Maria Quinones, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290387
- Sponsor's protocol ID
- STUDY00009037
- Other IDs
- 5P30AG064200
- Status last verified
- May 2026
- First submitted
- 15 Dec 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Savvy for Latino Caregivers
- ClinicalTrials.gov ID
- NCT07290387
- Acronym / sponsor ID
- STUDY00009037
- Conditions
- Alzheimer Disease, Dementia, Caregiver Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 Dec 2025 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Tele Savvy for Latino Caregivers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Tele Savvy for Latino CaregiversTele 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. | Behavioural | Intervention |
Primary outcome
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.
5 secondary outcomes
Mean Change in Perceived Stress Scale Score
Time frame: Baseline to Three Months Post Intervention
Mean Change in Total Zarit Caregiver Burden Scale Score
Time frame: Baseline to Three Months Post Intervention
Mean Change in Total CES D R Depression Score
Time frame: 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
Mean Total Satisfaction Questionnaire Score Immediately Post Intervention
Time frame: Immediately following completion of the seven week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele Savvy for Latino Caregivers in people with Alzheimer Disease and Dementia, run by University of Rochester 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Quiñones, PhD ((585) 276-3903, Maria_Quinones@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Caregiver Mastery Score (time frame: Baseline to three months post intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.