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Набор скоро начнётся NCT06963970

Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans

Без фазы С лечением Dementia Cancer Renal Disease Obstructive Pulmonary Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Remote Community Health Worker support.
Кому может быть актуально
Состояния в реестре: Dementia, Cancer, Renal Disease, Obstructive Pulmonary Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

The investigators aim to support care partner's well-being and satisfaction with VA care and decrease their work burden by offering extra support from a trained Community Health Worker who will help connect the care partner to helpful resources in their communities and in the VA. The investigators also hope to help Veterans well-being and satisfaction with VA care by supporting their care partner more sufficiently allowing the care partner to focus on caregiving tasks.

Подробное описание

Aim 1: Determine CSNAV effectiveness in increasing rural Veterans' well-being, reducing rural care partner burden, and increasing rural care partner/Veteran satisfaction with VA care in the intervention group compared with the usual care (CSP) group. The investigators will apply a 6-month intervention in a randomized control trial over 27 months. Primary Outcome: (H1) Care partners randomized to intervention group will have lower mean Zarit-1216 burden scores at 6 months compared to the control group. Secondary Outcomes: (H2) Care partners and Veterans randomized to the intervention group will have higher mean CAHPS Global Satisfaction17 scores at 6 months compared to the control group. (H3) Veterans randomized to the intervention group will have higher mean Warwick Edinburgh Mental Well-Being Scale18 scores at 6 months compared to the control group.

Aim 2: Following intervention, the investigators explore Veterans' and care partners' experience of CHWs as a mode of VA support using semi-structured interviews. The investigators then facilitate Delphi Method sessions with the Community Advisory Board plus study Veterans/care partners, CHWs, and key operational partners to examine Aims 1 \& 2 data for intervention improvements and implementation planning using updated CFIR.19

Aim 3: Conduct budget impact analysis from the VA perspective to evaluate cost-drivers and assess feasibility to inform adaptation and implementation of the intervention within a VA regional network.

Вмешательства

  • Другое Remote Community Health Worker support
    trained/certified community health worker supporting care partner remotely

Первичные конечные точки

  • Zarit-12 Cargiver Burden Interview [Срок оценки: baseline and 6 months]
Вторичные конечные точки (3)
  • 1-item CAHPS Global Satisfaction Measure [Срок оценки: baseline and 6 months]
  • Warwick Edinburgh Mental Well-Being Scale [Срок оценки: baseline and 6 months]
  • Connection Measure [Срок оценки: baseline and 6 months]

Критерии участия

Критерии включения

Care Partner Inclusion Criteria

  • A relative, friend, or partner (18 years of age) with whom Veteran patient has a personal relationship who assists Veteran regularly with care and/or care coordination as defined under "Veterans" below
  • Residing in a rural area based on RUCC or Rural-Urban Continuum Codes83
  • Must be enrolled in CSP Program of General Caregiver Support Services
  • Can live with or separately from the Veteran; able to communicate in English by phone

Veteran Inclusion Criteria

  • Receiving care at Durham, Asheville, and Richmond VA Health Systems (e.g., at least 2 outpatient visits in past year; has a primary provider) and residing in a rural area.
  • Diagnosed with congestive heart failure, chronic obstructive pulmonary disease, cancer, dementia, or end-stage renal disease.
  • Requires assistance with at least one ADL (i.e., walking, feeding, toileting, transferring, bathing, or dressing) or IADL (i.e., transport, medication, financial management, shopping, or meal preparation)
  • 50 years old or older and able to communicate in English by phone (for assessments)

Критерии исключения

Veteran Exclusion Criteria

  • Flag or social work note indicating suspected Caregiver abuse.
  • Unable to communicate in English by phone for assessments.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Durham VA Medical Center, Durham, NC — Durham

Идентификаторы

NCT: NCT06963970 · SDR 24-078 · 1l01HX003922-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗