Quality of Life Impact After Enhanced Follow-up of Ostomy Patients (StomaCare)

Quality of Life Impact After Enhanced Follow-up of Ostomy Patients by a Home Healthcare Nursing Service Employing Stomal Therapy Nurse Consultants Compared to Conventional Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Stoma Ileostomy; Stoma Colostomy
• Intervention / Treatment: Other: standard of care; Other: stoma follow-up

Detailed Description

France currently has about 80,000 ostomy patients. Stoma placement exposes patients to many surgical or peristomal skin complications which could impair the quality of life of the ostomy patient.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 93043
    • Hôpital Bicêtre
  • Lyon, France
    • Hôpital Lyon-Sud
  • Paris, France, 75012
    • Hôpital Saint-Antoine
  • Paris, France, 75013
    • Hôpital de la Pitié-Salpêtrière
  • Paris, France, 75009
    • Hopital Saint Louis
  • Paris, France, 75009
    • Hopital Saint-Louis
  • Paris, France, 75015
    • Hopital HEGP
  • Suresnes, France
    • ESPIC FOCH - Digestige Unit
  • Suresnes, France
    • ESPIC Foch - Urology Unit
  • Toulouse, France
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.	Other: standard of care; routine management of stoma
Experimental: 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of patient	scale 0-100	3 and 6 months
Quality of life	Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean	1, 2, 3 and 6 months
Quality of life	EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean	1, 2, 3 and 6 months
Cost	• Calculation of resource use at 3 and 6 months per expenditure item (use of services, drug use, medical device and home healthcare service use, MCO (Médecine chirurgie obstétrique [Obstetric surgery]) hospitalisations and SSR (Soins de suite et de réadaptation [Follow-up care and rehabilitation]) hospitalisations) for each group.	3 and 6 months
Morbidity	readmission rate	3 and 6 months

Collaborators and Investigators

• Sponsor: FSK

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Website of FSK

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: FSK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No