Clincosm LogoSign in Get a demo

STOM'HAD: Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization

Sponsor
Fondation Sante Service (Other)
Overall Status
Recruiting
CT.gov ID
NCT05457660
Collaborator
(none)
100
Enrollment
1
Location
6.5
Anticipated Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization
    Actual Study Start Date :
    Feb 15, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Measuring the quality of life of colostomized or ileostomized patients in home hospitalization [4 months]

    Secondary Outcome Measures

    1. Identify patient issues and needs. [4 months]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondation Santé Service Levallois-Perret France 92300

    Sponsors and Collaborators

    • Fondation Sante Service

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondation Sante Service
    ClinicalTrials.gov Identifier:
    NCT05457660
    Other Study ID Numbers:
    • 2022-A00014-39
    First Posted:
    Jul 14, 2022
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fondation Sante Service
    Home Hospitalization
    Colostomy
    Ileostomy

    Study Results

    No Results Posted as of Jul 14, 2022