Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
NCT ID: NCT05076669
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
350 participants
INTERVENTIONAL
2021-10-31
2023-12-31
Brief Summary
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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.
Detailed Description
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The management of ostomy patients varies from institution to institution and according to how the patient's medical equipment is supplied as well as whether or not specialised personnel are available.
In the last decade, the market for stoma therapy in France has evolved, with a significant increase in the delivery of equipment by HHNs, meeting a need for patient follow-up and accompaniment.
This increased preference of HHNs to use specialist nurses seems to be explained by the added benefits. Early international studies have demonstrated the impact of an enterostomal therapy nurse follow-up on the improvement of ostomy patient's quality of life (QoL) relative to their health.
However, none of the studies available today on follow-ups performed by an enterostomal therapist included the French population. Furthermore, the studies show methodological gaps, a limited time span and are based on strong hypotheses.
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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.
standard of care
routine management of stoma
interventional group
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.
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
Interventions
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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
standard of care
routine management of stoma
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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FSK
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremie H Lefevre, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sorbonne University
Locations
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Hopital Bicètre
Le Kremlin-Bicêtre, , France
Hopital Lyon-Sud
Lyon, , France
Hopital SAint Louis
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital Saint-Antoine
Paris, , France
Hopital de la Pitié-Salpétrière
Paris, , France
Hopital HEGP
Paris, , France
ESPIC FOCH - Digestige Unit
Suresnes, , France
ESPIC Foch - Urology Unit
Suresnes, , France
CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Eddy Cotte, MD, PhD
Role: primary
Alexandra Masson-Lecomte, MD
Role: primary
Jeremie Lefevre
Role: primary
Yann Neuzillet, MD,PhD
Role: primary
Mathieu Roumiguié, MD
Role: primary
References
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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.
Persson 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.
Neil 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.
Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55.
Danielsen 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.
Related Links
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Website of FSK
Other Identifiers
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FSK-001
Identifier Type: -
Identifier Source: org_study_id
NCT05061927
Identifier Type: -
Identifier Source: nct_alias