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NCT05457660 Clinical Trial

Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization

Colostomy Clinical Trial

— STOM'HAD  

Official title:
Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05457660
Other study ID # 2022-A00014-39
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2022
Est. completion date September 2022

Study information
Verified date July 2022
Source Fondation Sante Service
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goalf of the study is to have a basis about QOL for colo-stoma and ileo-stoma for patients which are hospitalized at home. The QOL measurement is done with a questionnaire of several items made by stomatherapist and also using EQ5D QOL form. After reviewing of the data, our goal is to create or improve some solutions to improve their QOL during their home hospitalization.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Colo-stomy or Ileo-stomy patient - Patient hospitalized at home by Fondation Sante Service (Fr) - 18 YO or more - Non-opposition to the study Exclusion Criteria: - Patient not able to read or properly understand the Information Consent Form and not able to complete the questionnaire for any reason.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Fondation Santé Service Levallois-Perret

Sponsors (1)
Lead Sponsor Collaborator
Fondation Sante Service

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measuring the quality of life of colostomized or ileostomized patients in home hospitalization 4 months
Secondary Identify patient issues and needs. 4 months
Secondary Analyze the results by subgroups of patients: according to the type of stoma (ileostomy vs. colostomy; temporary stomy vs. permanent stoma), age of the stoma, age, pathology. 4 months
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