- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01851785
African American Preference for Knee Replacement: A Patient-Centered Intervention (ACTION)
Behavioral & Social Science Research on Understanding and Reducing Health Disparities
A randomized, controlled design will be utilized to examine and compare the effectiveness of the proposed educational intervention, which includes an educational decision aid with attention control on select key patient-centered and process of care outcomes. The study sample will consist of approximately 300 African-American patients with osteoarthritis (OA) of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center and the Philadelphia VA Medical Center and will be randomized to one of the two study arms.
The immediate goal of this randomized controlled trial is to assess the effect of a high-quality, evidence-based, patient-centered educational intervention on African American patient preferences, expectations, and the likelihood of receiving a recommendation for knee joint replacement surgery when clinically indicated. The long-term goal of this research is to implement effective strategies to improve minority patients' access to joint replacement and ultimately eliminate racial disparities in the utilization of this effective treatment for knee OA.
Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis: The DA intervention will lead to higher rate of treatment recommendation within 6 months.
Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will undergo knee replacement within 12 months at a higher rate than those in the attention control group.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- University of Pennsylvania
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- African-American patient referred to orthopedic doctor
- Age 50 or older
- Presence of knee OA by American College of Rheumatology as evidenced by:
- Chronic, frequent knee pain based on the NHANES questions.
- Moderate to severe knee OA based on WOMAC index score 39.
- Radiographic evidence of knee OA.
Exclusion Criteria:
- Prior history of any major joint replacement.
- Terminal Illness (e.g. end stage cancer).
- Physician diagnosed inflammatory arthritis (i.e., rheumatoid arthritis, connective tissue disease, ankylosing spondylitis, or other seronegative Spondyloarthropathy.)
- Contra-indications to replacement surgery (e.g., lower extremity paralysis as result of stroke).
- Prosthetic leg
- Cognitive impairment (e.g.,dementia)
- No home telephone service.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: Attention control
Subjects randomized to the attention control arm will receive an educational program (an NIH-developed booklet) that summarizes how to live with knee OA but does not specifically mention joint replacement.
This booklet provides information about OA, examples of exercises one could do to improve pain and reduce stiffness, types of non-drug pain relief such as massage, and information about various medications.
The interventionist will give the participant the booklet and describe what can be found inside.
They are also encouraged to ask their doctor any questions they may have about the information in the booklet or questions they may have about their OA.
The purpose of this educational program is to provide a tangible clinical incentive to the control group for participating in this additional component of the study.
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Экспериментальный: Decision Aid (DA) Intervention
Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called "AskMe3."
The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment.
The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?
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Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called "AskMe3."
The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment.
The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Recommendation of knee joint replacement
Временное ограничение: 6 months after intervention
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Recommendation of knee joint replacement 6 months after intervention will be assessed for all patients by chart abstraction.
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6 months after intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Receipt of knee joint replacement
Временное ограничение: assessed for all patients 12 months post-intervention
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Receipt of knee joint replacement will be assessed for all patients 12 months post-intervention initially through telephone survey and then validated by medical record review.
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assessed for all patients 12 months post-intervention
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Said A Ibrahim, MD, MPH, University of Pennsylvania
- Главный следователь: Gwo-Chin Lee, MD, University of Pennsylvania
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 5R01AR059615-03 (Грант/контракт NIH США)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Decision Aid (DA) Intervention
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