CAPABLE Transplant
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: CAPABLE Transplant- Open Label Pilot, CAPABLE Transplant- Randomized Control Trial.
- Кому может быть актуально
- Состояния в реестре: Quality of Life, Depression, End Stage Renal Disease, Disability Physical. Базовые параметры: 18 лет — 99 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program
Обзор
The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.
Подробное описание
CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment but has not been explored in prehabilitation research. The purpose of this study is to adapt CAPABLE, an existing evidence-based program for functionally and socio-economically vulnerable older adults, as a prehabilitation intervention for people with frailty awaiting KT.
As in CAPABLE, the delivery characteristics of CAPABLE Kidney Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW).
In earlier phases, research team members conducted preliminary activities to design the CAPABLE Kidney Transplant intervention using Human-Centered Design techniques.
This study will seek to accomplish two aims:
1. To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive or those who are active and low-income on the waitlist. 2. To pilot test the CAPABLE-Transplant intervention
The investigators will collect feedback during the open label pilot to further refine the intervention that will be tested as part of the randomized control trial.
Вмешательства
- Поведенческое CAPABLE Transplant- Open Label Pilot
As in CAPABLE, the delivery characteristics of CAPABLE Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW). Adaptations targeting those currently KT inactive will be made on a per-client basis as part of the open-label pilot. We will further refine and develop the intervention b - Поведенческое CAPABLE Transplant- Randomized Control Trial
As in CAPABLE, the delivery characteristics of CAPABLE Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW). Refinements based on the open label pilot results will be included.
Первичные конечные точки
- Waitlist-status as assessed by data obtained by the National Kidney Registry [Срок оценки: 0, 16 weeks, 32 weeks]
Вторичные конечные точки (11)
- Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Pain as assessed by the Brief Pain Inventory [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8) [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Social engagement as assessed by the Lubben Social Network Scale [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Frailty as assessed by the Fried Frailty Phenotype [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Health Team Communication as assessed by the CollaboRATE Scale Measure [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale [Срок оценки: Baseline, 16 weeks, 32 weeks]
- Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living [Срок оценки: Baseline, 16 weeks, 32 weeks]
Критерии участия
Критерии включения
- Deceased Donor Waitlist
- ≥18 years old
- Community dwelling
- Current Inactive status or active and had been inactive in the last 18 months for cardiovascular disease, frailty, obesity, social support, mental health, incomplete testing OR Active on the waitlist and low-income
Критерии исключения
- Living Donor Waitlist
- Severe cognitive impairment
- Inactivity expected to last > 3 months (eg cancer treatment)
- >4 hospitalizations in the last 12 months
- Current home nursing, physical or occupational therapy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- Johns Hopkins School of Nursing — Baltimore
Идентификаторы
NCT: NCT06326905 · IRB00437750 · K23DK133677-01A1