Quality of Life Impact After Enhanced Follow-up of Ostomy Patients (StomaCare)

FSK

Status: Unknown

Conditions: Stoma Colostomy; Quality of Life; Stoma Ileostomy

Treatments: Other: stoma follow-up; Other: standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05076669

FSK-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Control

Active Comparator group

Description:

The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.

Treatment:

Other: standard of care

interventional group

Experimental group

Description:

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.

Treatment:

Other: stoma follow-up