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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Le Kremlin-Bicêtre、法国、93043
- Hôpital Bicêtre
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Lyon、法国
- Hôpital Lyon-Sud
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Paris、法国、75012
- Hôpital Saint-Antoine
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Paris、法国、75013
- Hôpital de la Pitié-Salpêtrière
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Paris、法国、75009
- Hopital Saint Louis
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Paris、法国、75009
- Hôpital Saint-Louis
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Paris、法国、75015
- Hopital HEGP
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Suresnes、法国
- ESPIC FOCH - Digestige Unit
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Suresnes、法国
- ESPIC Foch - Urology Unit
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Toulouse、法国
- CHU Toulouse
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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
|
|
实验性的：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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Efficacy
大体时间：3 months
|
score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Satisfaction of patient
大体时间：3 and 6 months
|
scale 0-100
|
3 and 6 months
|
|
Quality of life
大体时间：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
大体时间：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
大体时间：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
大体时间：3 and 6 months
|
readmission rate
|
3 and 6 months
|
合作者和调查者
赞助
出版物和有用的链接
一般刊物
- 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.
有用的网址
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- FSK-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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