University of Rochester School of Nursing
Rochester, New York, 14642, United States
Location status: Recruiting
Location contact
Maria Quiñones-Cordero, PhD
CONTACT
Maria Quiñones-Cordero, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07290387
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rochester, New York, 14642, United States
Location status: Recruiting
Maria Quiñones-Cordero, PhD
CONTACT
Maria Quiñones-Cordero, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University of Rochester
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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