Clinical trial NCT05076669: Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stoma Ileostomy
Stoma Colostomy
Quality of Life
Lead sponsor: FSK
Sponsor class: INDUSTRY
First posted: 2021-10-13
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, randomised, comparative, controlled, national and multi-centre study with minimal risks and constraints to routine care.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy
timeFrame: 3 months
Secondary outcomes:
measure: Satisfaction of patient
timeFrame: 3 and 6 months
measure: Quality of life
timeFrame: 1, 2, 3 and 6 months
measure: Quality of life
timeFrame: 1, 2, 3 and 6 months
measure: Cost
timeFrame: 3 and 6 months
measure: Morbidity
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicètre
city: Lyon
country: France
facility: Hopital Lyon-Sud
city: Paris
country: France
facility: Hopital SAint Louis
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Saint-Antoine
city: Paris
country: France
facility: Hopital de la Pitié-Salpétrière
city: Paris
country: France
facility: Hopital HEGP
city: Suresnes
country: France
facility: ESPIC FOCH - Digestige Unit
city: Suresnes
country: France
facility: ESPIC Foch - Urology Unit
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: Sorbonne University
name: Jeremie H Lefevre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.
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.