Quality of Life Impact After Enhanced Follow-up of Ostomy Patients

Quality of Life Clinical Trial

— StomaCare  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05076669
• Other study ID #: FSK-001
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Quality of Life
• Stoma Colostomy
• Stoma Ileostomy

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

External Links

•   Website of FSK