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
试验速览
- 阶段
- 不适用
- 发起方
- FSK
- 入组人数
- 350
- 试验地点
- 16
- 主要终点
- Efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Efficacy
时间窗: 3 months
score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean
次要结局
- Cost(3 and 6 months)
- Satisfaction of patient(3 and 6 months)
- Morbidity(3 and 6 months)
- Quality of life(1, 2, 3 and 6 months)