NCT05457660

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 11, 2022

Last Update Submit

July 11, 2022

Conditions

ColostomyIleostomyHome Hospitalization

Keywords

Home HospitalizationColostomyIleostomy

Outcome Measures

Primary Outcomes (1)

  • Measuring the quality of life of colostomized or ileostomized patients in home hospitalization

    4 months

Secondary Outcomes (2)

  • Identify patient issues and needs.

    4 months

  • 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

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stoma : Colostomy and Ileostomy

You may qualify if:

  • Colo-stomy or Ileo-stomy patient
  • Patient hospitalized at home by Fondation Sante Service (Fr)
  • YO or more
  • Non-opposition to the study

You may not qualify if:

  • Patient not able to read or properly understand the Information Consent Form and not able to complete the questionnaire for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Santé Service

Levallois-Perret, 92300, France

RECRUITING

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 14, 2022

Study Start

February 15, 2022

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)