Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease

Официальное название

Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease: A Hybrid Effectiveness-Implementation Study of Caregiving Support in Cardiac Rehabilitation

Обзор

The purpose of this study is to evaluate the preliminary efficacy, feasibility, acceptability, and barriers and facilitators to implementation of the Confident Caregiver intervention among family caregivers of persons with cardiovascular disease participating in cardiac rehabilitation. Caregivers receive four individualized intervention sessions focused on assessment of caregiving challenges, tailored coaching, stress reduction, education, and referrals to supportive resources. Outcomes include reductions in caregiving-related challenges, improvements in mental health, and reductions in stress.

Подробное описание

This Type 1 hybrid effectiveness-implementation study evaluates the Confident Caregiver intervention among family caregivers of persons with cardiovascular disease enrolled in cardiac rehabilitation. The intervention consists of four individualized sessions delivered virtually by a trained interventionist over approximately 8 to 12 weeks. Sessions include assessment of caregiving challenges, tailored coaching and action planning to address caregiving challenges, stress reduction strategies, caregiver education, and referrals to services and supports.

Primary intervention efficacy endpoints are: improvement in caregiving challenges and improvement in caregiving-related difficulties

Secondary intervention efficacy endpoints are: improvement in caregiver mental health (depression, anxiety), improvement in caregiver stress (both general and caregiving-specific), and improvement in caregiver overall well-being

Exploratory intervention efficacy endpoints are: improvement in clinic-level cardiac rehab outcomes for cardiac rehab patients (average # of sessions attended, average program completion, program satisfaction, improvement in patient biomarkers, and improvement in person-centered patient outcomes)

Investigators will also evaluate the feasibility and acceptability of intervention for caregiver participants and clinicians in cardiac rehab

Вмешательства

• Поведенческое Confident Caregiver Intervention
  All enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included.

Первичные конечные точки

• Level of Caregiving Difficulty Scale - developed by Gitlin et al and previously used in the COPE trial (Care of Persons With Dementia in Their Environments). Range 1-10, higher scores indicate greater caregiving difficulty. [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Level of Caregiving Upset Scale - developed by Gitlin et al and previously used in the COPE trial. Range 1-10, higher scores indicate greater caregiving-related upset. [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Level of Caregiving Confidence Scale - developed by Gitlin et al and previously used in the COPE trial. Range 1-10, higher scores indicate greater caregiving confidence. [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]

Вторичные конечные точки (10)

• Change in Caregiver Depression [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Change in Caregiver Anxiety [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Change in Caregiver Stress (General) [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Change in Overall Caregiving Stress [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Change in Caregiver Stress (Physical) [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Change in Caregiver Stress (Emotional) [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Change in Caregiver Stress (Financial) [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Overall Improvement in Caregiver Well-Being [Срок оценки: At time of completion of the Confident Caregiver Intervention]
• Change in Caregiver Physical Health Status [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]
• Change in Caregiver Mental Health Status [Срок оценки: From baseline to immediately following completion of the Confident Caregiver intervention]

Критерии участия

Критерии включения

• 18 years of age or older
• Is a caregiver for a patient receiving care in our UC Davis Cardiac Rehabilitation Clinic. A caregiver is defined as someone who provides support to the patient with one or more basic or instrumental activities of daily living.
• Has one or more caregiving-related challenges or issues that they would like support with
• Is able to read and speak in English

Критерии исключения

• Is a paid professional caregiver with no family or fictive kin relationship with the care recipient
• Has a diagnosis of major cognitive impairment or Alzheimer's or related dementias
• Is unable to complete the protocol or participate in the intervention (e.g., unavailable during the intervention period, unable to access or use virtual meeting technology)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of California Davis Health System — Sacramento

Идентификаторы

NCT: NCT07717723 · 2369399 · GBMF9048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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