Stoma IleostomyStomaCareNCT05076669
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
A study testing stoma follow-up in people with Stoma Ileostomy and Stoma Colostomy, run by FSK at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy, Stoma Colostomy, Quality of Life
- What is being tested?
- stoma follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 10 sitesFrance
- Study dates
- Oct 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hopital Bicètre
Le Kremlin-Bicêtre, 93043
Hopital Lyon-Sud
Lyon
Eddy Cotte, MD, PhD
Eddy Cotte, MD, PhD
Hopital SAint Louis
Paris, 75009
Alexandra Masson-Lecomte, MD
Alexandra Masson-Lecomte
Hopital Saint-Louis
Paris, 75009
Hopital Saint-Antoine
Paris, 75012
Jeremie Lefevre
Jeremie H Lefevre, MD,PhD
Hopital de la Pitié-Salpétrière
Paris, 75013
Hopital HEGP
Paris, 75015
ESPIC FOCH - Digestige Unit
Suresnes
ESPIC Foch - Urology Unit
Suresnes
Yann Neuzillet, MD,PhD
Yann Neuzillet, MD, PhD
CHU Toulouse
Toulouse
Mathieu Roumiguié, MD
Mathieu Roumiguié, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Quality of Life
- Being tested
- stoma follow-up, standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stoma follow-upOther
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 careOther
routine management of stoma
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK. Receives: Other: standard of care |
| interventional group | Experimental | 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. Receives: Other: stoma follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean
Measured: 3 months
Secondary outcomes (5)
Satisfaction of patient
scale 0-100
Measured: 3 and 6 months
Quality of life
Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean
Measured: 1, 2, 3 and 6 months
Quality of life
EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean
Measured: 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.
Measured: 3 and 6 months
Morbidity
readmission rate
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stoma IleostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, randomised, comparative, controlled, national and multi-centre study with minimal risks and constraints to routine care.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FSK
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremie H Lefevre, MD, PhD, Principal investigator, Sorbonne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076669
- Sponsor's protocol ID
- FSK-001
- Acronym
- StomaCare
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10390579Persson 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.
PubMed 19519689Neil 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.
PubMed 26633166Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55.
PubMed 12598701Danielsen 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.
PubMed 24609004
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05076669
- Acronym / sponsor ID
- StomaCare / FSK-001
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- FSKIndustry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomised, comparative, controlled, national and multi-centre study with minimal risks and constraints to routine care.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: standard of careThe control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK. |
| interventional group | Experimental | Other: stoma follow-upThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stoma follow-updelivery 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 | interventional group |
| standard of careroutine management of stoma | Other | Control |
Primary outcome
Efficacy
Time frame: 3 months
score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean
5 secondary outcomes
Satisfaction of patient
Time frame: 3 and 6 months
Quality of life
Time frame: 1, 2, 3 and 6 months
Quality of life
Time frame: 1, 2, 3 and 6 months
Cost
Time frame: 3 and 6 months
Morbidity
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Background: PubMed 10390579Becker 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.
- Results publication: PubMed 19519689Persson 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.
- Results publication: PubMed 26633166Neil 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.
- Results publication: PubMed 12598701Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55.
- Results publication: PubMed 24609004Danielsen 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.
- Website of FSKLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremie H Lefevre, MD, PhD principal investigator
Sorbonne University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stoma follow-up in people with Stoma Ileostomy and Stoma Colostomy, run by FSK at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Kuhn (+33 7 61 47 98 25, i.kuhn@fsk.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076669, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.