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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Le Kremlin-Bicêtre, 프랑스, 93043
- Hôpital Bicêtre
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Lyon, 프랑스
- Hôpital Lyon-Sud
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Paris, 프랑스, 75012
- Hôpital Saint-Antoine
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Paris, 프랑스, 75013
- Hôpital de la Pitié-Salpêtrière
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Paris, 프랑스, 75009
- Hopital Saint Louis
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Paris, 프랑스, 75009
- Hôpital Saint-Louis
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Paris, 프랑스, 75015
- Hopital HEGP
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Suresnes, 프랑스
- ESPIC FOCH - Digestige Unit
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Suresnes, 프랑스
- ESPIC Foch - Urology Unit
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Toulouse, 프랑스
- CHU Toulouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Control
The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.
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routine management of stoma
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실험적: 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.
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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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Efficacy
기간: 3 months
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score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Satisfaction of patient
기간: 3 and 6 months
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scale 0-100
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3 and 6 months
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Quality of life
기간: 1, 2, 3 and 6 months
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Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean
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1, 2, 3 and 6 months
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Quality of life
기간: 1, 2, 3 and 6 months
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EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean
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1, 2, 3 and 6 months
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Cost
기간: 3 and 6 months
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• 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.
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3 and 6 months
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Morbidity
기간: 3 and 6 months
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readmission rate
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3 and 6 months
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- 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.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FSK-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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