Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
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: CARE-D-Foot-Nav, Standard of care.
- Кому может быть актуально
- Состояния в реестре: Diabetic Foot Ulcer. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav)
Обзор
The purpose of this interventional study is to assess the effectiveness of CARE-D-Foot, a patient navigator intervention, as compared to usual care, on 20-week diabetic foot ulcer healing. The study will further: * Evaluate fidelity to and acceptability of the CARE-D-Foot-Nav program using mixed methods * Perform a CARE-D-Foot-Nav cost-effectiveness analysis (CEA)
Подробное описание
The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a randomized controlled trial testing whether a patient navigator-led intervention can improve healing outcomes for patients hospitalized with diabetic foot ulcers (DFUs). DFUs are a serious complication of diabetes that contribute to over 100,000 amputations annually in the U.S. and account for a significant portion of diabetes-related healthcare costs. Healing requires complex, multidisciplinary care focused on glycemic control, wound management, vascular disease treatment, and infection therapy. However, many patients, especially underserved populations such as non-Hispanic Black and Hispanic individuals, face barriers related to social determinants of health that hinder access to this care.
In this trial, 270 patients hospitalized with DFUs will be randomized to receive either usual care or participate in the CARE-D-Foot-Nav program for 20 weeks after hospital discharge. Participants in the intervention group will receive weekly support from a certified diabetes educator acting as a patient navigator, who will provide personalized care coordination, diabetes education, transportation assistance, and help connecting patients to medical and social resources.
Navigators have proven effective in improving outcomes for other chronic diseases by overcoming healthcare system and patient-level barriers, but no prior randomized trials have tested their impact on DFU care specifically. This study aims to fill that gap by evaluating whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively. The intervention is designed to be scalable and focused on reducing healthcare disparities to help curb the diabetes-related amputation epidemic.
Вмешательства
- Другое CARE-D-Foot-Nav
CARE-D-Foot-Nav is a diabetes educator who will serve as a dedicated Diabetic Foot Ulcer (DFU) patient navigator. The navigator will assist the subjects with diabetic foot ulcer care, including: Glycemic control, Wound management, Infection management, and peripheral artery disease (PAD) management. Apart from that, the navigator will also provide tools to improve access to DFU care and emotional support, like: Outpatient care coordination, Transportation assistance, Language-concordant care, - Другое Standard of care
Standard of care for DFU.
Первичные конечные точки
- Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound [Срок оценки: Baseline, Week 20 (day 140 +/- 7 days)]
Вторичные конечные точки (12)
- Number of participants with confirmed wound healing [Срок оценки: Baseline, week 22]
- DFU care clinic attendance [Срок оценки: Within 14 and 30 days post hospital discharge]
- Wound area reduction [Срок оценки: Baseline, Week 20]
- Major amputation [Срок оценки: Baseline, Week 20]
- Number of deaths [Срок оценки: Baseline, Week 20]
- EuroQol five-dimensional (EQ-5D) score [Срок оценки: Baseline, Week 20]
- Glycemic control: Change in HbA1c [Срок оценки: Baseline, Week 20]
- Perceived social support: Interpersonal Support Evaluation List-12 [Срок оценки: Baseline, Week 20]
- Medical mistrust: Change in the Trust in Physicians Scale [Срок оценки: Baseline, Week 20]
- Tobacco cessation [Срок оценки: Baseline, Week 20]
- Acute care utilization [Срок оценки: After hospital discharge (up to 20 weeks)]
- Services accessed [Срок оценки: Baseline, Week 20]
Критерии участия
Критерии включения
- Adults with diabetes admitted for any reason who have a full-thickness DFU (defined as a wound below the ankle through the dermis) or undergo a single toe amputation
- History of prior amputations and DFUs of any severity
Критерии исключения
- Adults unable to understand the nature and scope of the study, enrolled in another clinical trial, or planned for discharge to an acute or long-term care facility,
- Patients who undergo amputation of two or more toes during hospitalization and/or have a Society for Vascular Surgery Wound, Ischemia, foot Infection grade 4
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
- Лечение
Центры проведения
США · 1 центр
- Grady Memorial Hospital — Atlanta
Публикации
- Schechter MC, Rhodes EC, Shao H, Ahmed S, Colquitt K, Chaudhry NY, Dunlop AL, Flores J, Garcia-Toca M, Javia V, Kalokhe AS, Manoj A, Meadows C, Meriwether N, Sales JM, Soleimanmanesh N, Santamarina G, Smith-Bankhead NK, Umpierrez G, Ramos CR, Watson E, Peng L, Fayfman M. A randomized controlled trial of patient navigators for post-hospital discharge diabetic foot ulcer care: the Comprehensive Assi PMID 41358308
Идентификаторы
NCT: NCT07223268 · STUDY00008140 · 1R01DK139326-01A1