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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG064200 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele Savvy for Latino Caregivers | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria QuiƱones, PhD | Contact | (585) 276-3903 | Maria_Quinones@URMC.Rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester School of Nursing | Recruiting | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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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.
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| 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. | 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. | 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. | 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. | Immediately following completion of the seven week intervention |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |