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

Not Applicable

• Conditions: Quality of Life; Stoma Ileostomy; Stoma Colostomy
• Interventions: Other: stoma follow-up; Other: standard of care

• Registration Number: NCT05076669
• Lead Sponsor: FSK

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Study Start: 2021-10
• Study First Posted: 2021-10-13
• Last Update Posted: 2021-10-13
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional group	stoma follow-up	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.
Control	standard of care	The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.

Primary Outcome Measures

Name	Time	Method
Efficacy	3 months	score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean

Secondary Outcome Measures

Name	Time	Method
Cost	3 and 6 months	• 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.
Satisfaction of patient	3 and 6 months	scale 0-100
Quality of life	1, 2, 3 and 6 months	EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean
Morbidity	3 and 6 months	readmission rate

Trial Locations

Locations (10)

Hopital HEGP; 🇫🇷 Paris, France

Hopital Saint-Antoine; 🇫🇷 Paris, France

CHU Toulouse; 🇫🇷 Toulouse, France

Hopital Bicètre; 🇫🇷 Le Kremlin-Bicêtre, France

ESPIC FOCH - Digestige Unit; 🇫🇷 Suresnes, France

Hopital SAint Louis; 🇫🇷 Paris, France

Hopital Lyon-Sud; 🇫🇷 Lyon, France

Hopital Saint-Louis; 🇫🇷 Paris, France

Hopital de la Pitié-Salpétrière; 🇫🇷 Paris, France

ESPIC Foch - Urology Unit; 🇫🇷 Suresnes, France