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

NCT05076669 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2021-10-13

No results posted yet for this study

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.

Conditions

  • Stoma Ileostomy
  • Stoma Colostomy
  • Quality of Life

Interventions

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

OTHER

standard of care

routine management of stoma

Sponsors & Collaborators

  • FSK

    lead INDUSTRY

Principal Investigators

  • Jeremie H Lefevre, MD, PhD · Sorbonne University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2023-08-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076669 on ClinicalTrials.gov