Quality of Life Impact After Enhanced Follow-up of Ostomy Patients (StomaCare)
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients by a Home Healthcare Nursing Service Employing Stomal Therapy Nurse Consultants Compared to Conventional Care
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.
The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites.
The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
France currently has about 80,000 ostomy patients. Stoma placement exposes patients to many surgical or peristomal skin complications which could impair the quality of life of the ostomy patient.
The management of ostomy patients varies from institution to institution and according to how the patient's medical equipment is supplied as well as whether or not specialised personnel are available.
In the last decade, the market for stoma therapy in France has evolved, with a significant increase in the delivery of equipment by HHNs, meeting a need for patient follow-up and accompaniment.
This increased preference of HHNs to use specialist nurses seems to be explained by the added benefits. Early international studies have demonstrated the impact of an enterostomal therapy nurse follow-up on the improvement of ostomy patient's quality of life (QoL) relative to their health.
However, none of the studies available today on follow-ups performed by an enterostomal therapist included the French population. Furthermore, the studies show methodological gaps, a limited time span and are based on strong hypotheses.
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.
The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites.
The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Le Kremlin-Bicêtre, Франция, 93043
- Hôpital Bicêtre
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Lyon, Франция
- Hôpital Lyon-Sud
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Paris, Франция, 75012
- Hôpital Saint-Antoine
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Paris, Франция, 75013
- Hôpital de la Pitié-Salpêtrière
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Paris, Франция, 75009
- Hôpital Saint Louis
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Paris, Франция, 75009
- Hôpital Saint-Louis
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Paris, Франция, 75015
- Hopital HEGP
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Suresnes, Франция
- ESPIC FOCH - Digestige Unit
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Suresnes, Франция
- ESPIC Foch - Urology Unit
-
Toulouse, Франция
- CHU Toulouse
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Male or female ≥ 18 years
- Patients with a stoma placed less than 10 days ago
- Patients who had a stoma during their current hospitalisation
- Patients informed verbally and in writing via the information sheet and who signed the informed consent form.
Exclusion Criteria:
- Patients in palliative care
- Patients participating in another clinical study interested in the management of ostomy patients
- Patients not enrolled in a social security system or with the CMU (Couverture maladie universelle [Universal Health Coverage])
- Patients under judicial protection or under guardianship
- Patients deprived of freedom (in prison and psychiatric patients being treated without consent)
- Patients with difficulties understanding or reading French
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Control
The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.
|
routine management of stoma
|
|
Экспериментальный: interventional group
The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites.
|
delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Efficacy
Временное ограничение: 3 months
|
score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean
|
3 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Satisfaction of patient
Временное ограничение: 3 and 6 months
|
scale 0-100
|
3 and 6 months
|
|
Quality of life
Временное ограничение: 1, 2, 3 and 6 months
|
Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean
|
1, 2, 3 and 6 months
|
|
Quality of life
Временное ограничение: 1, 2, 3 and 6 months
|
EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean
|
1, 2, 3 and 6 months
|
|
Cost
Временное ограничение: 3 and 6 months
|
• Calculation of resource use at 3 and 6 months per expenditure item (use of services, drug use, medical device and home healthcare service use, MCO (Médecine chirurgie obstétrique [Obstetric surgery]) hospitalisations and SSR (Soins de suite et de réadaptation [Follow-up care and rehabilitation]) hospitalisations) for each group.
|
3 and 6 months
|
|
Morbidity
Временное ограничение: 3 and 6 months
|
readmission rate
|
3 and 6 months
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Persson E, Berndtsson I, Carlsson E, Hallen AM, Lindholm E. Stoma-related complications and stoma size - a 2-year follow up. Colorectal Dis. 2010 Oct;12(10):971-6. doi: 10.1111/j.1463-1318.2009.01941.x.
- Neil N, Inglese G, Manson A, Townshend A. A Cost-Utility Model of Care for Peristomal Skin Complications. J Wound Ostomy Continence Nurs. 2016 Jan-Feb;43(1):62-8. doi: 10.1097/WON.0000000000000194.
- Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55.
- Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.
- Becker A, Schulten-Oberborsch G, Beck U, Vestweber KH. Stoma care nurses: good value for money? World J Surg. 1999 Jul;23(7):638-42; discussion 642-3. doi: 10.1007/pl00012361.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Ожидаемый)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- FSK-001
Планирование данных отдельных участников (IPD)
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов 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. .