Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
StomaCare
1 other identifier
interventional
350
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Typical duration for not_applicable
10 active sites
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
First Submitted
Initial submission to the registry
September 21, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 13, 2021
September 1, 2021
1.8 years
September 21, 2021
September 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy
score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean
3 months
Secondary Outcomes (5)
Satisfaction of patient
3 and 6 months
Quality of life
1, 2, 3 and 6 months
Quality of life
1, 2, 3 and 6 months
Cost
3 and 6 months
Morbidity
3 and 6 months
Study Arms (2)
Control
ACTIVE COMPARATORThe control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.
interventional group
EXPERIMENTALThe 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FSKlead
Study Sites (10)
Hopital Bicètre
Le Kremlin-Bicêtre, 93043, France
Hopital Lyon-Sud
Lyon, France
Hopital SAint Louis
Paris, 75009, France
Hopital Saint-Louis
Paris, 75009, France
Hopital Saint-Antoine
Paris, 75012, France
Hopital de la Pitié-Salpétrière
Paris, 75013, France
Hopital HEGP
Paris, 75015, France
ESPIC FOCH - Digestige Unit
Suresnes, France
ESPIC Foch - Urology Unit
Suresnes, France
CHU Toulouse
Toulouse, France
Related Publications (5)
Becker A, Schulten-Oberborsch G, Beck U, Vestweber KH. Stoma care nurses: good value for money? World J Surg. 1999 Jul;23(7):638-42; discussion 642-3. doi: 10.1007/pl00012361.
PMID: 10390579BACKGROUNDPersson E, Berndtsson I, Carlsson E, Hallen AM, Lindholm E. Stoma-related complications and stoma size - a 2-year follow up. Colorectal Dis. 2010 Oct;12(10):971-6. doi: 10.1111/j.1463-1318.2009.01941.x.
PMID: 19519689RESULTNeil N, Inglese G, Manson A, Townshend A. A Cost-Utility Model of Care for Peristomal Skin Complications. J Wound Ostomy Continence Nurs. 2016 Jan-Feb;43(1):62-8. doi: 10.1097/WON.0000000000000194.
PMID: 26633166RESULTMarquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55.
PMID: 12598701RESULTDanielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.
PMID: 24609004RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremie H Lefevre, MD, PhD
Sorbonne University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2021
First Posted
October 13, 2021
Study Start
October 1, 2021
Primary Completion
August 1, 2023
Study Completion
December 1, 2023
Last Updated
October 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share