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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05076669
Other study ID # FSK-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date December 2023

Study information

Verified date September 2021
Source FSK
Contact Ingrid Kuhn
Phone +33 7 61 47 98 25
Email i.kuhn@fsk.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 350
Est. completion date December 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
stoma follow-up
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
standard of care
routine management of stoma

Locations

Country Name City State
France Hopital Bicètre Le Kremlin-Bicêtre
France Hopital Lyon-Sud Lyon
France Hopital de la Pitié-Salpétrière Paris
France Hopital HEGP Paris
France Hopital SAint Louis Paris
France Hopital Saint-Antoine Paris
France Hopital Saint-Louis Paris
France ESPIC FOCH - Digestige Unit Suresnes
France ESPIC Foch - Urology Unit Suresnes
France CHU Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
FSK

Country where clinical trial is conducted

France, 

References & Publications (5)

Becker A, Schulten-Oberbörsch G, Beck U, Vestweber KH. Stoma care nurses: good value for money? World J Surg. 1999 Jul;23(7):638-42; discussion 642-3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Persson E, Berndtsson I, Carlsson E, Hallén 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean 3 months
Secondary Satisfaction of patient scale 0-100 3 and 6 months
Secondary Quality of life Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean 1, 2, 3 and 6 months
Secondary Quality of life EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean 1, 2, 3 and 6 months
Secondary Cost • 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
Secondary Morbidity readmission rate 3 and 6 months
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