Hereditary Epidermolysis BullosaFIREBNCT05248503
Impact of Complex Care Training of Hereditary Epidermolysis Bullosa on Caregiver Burden (FIREB)
An observational study of Hereditary Epidermolysis Bullosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hereditary epidermolysis bullosa (EBH) is a rare, orphan disease characterized by skin and mucous membrane fragility. The latest scientific data show that the proposed treatments are still in the experimental stage and that no curative treatment is available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Epidermolysis Bullosa
- What is being tested?
- Complex Care Training of Hereditary Epidermolysis Bullosa
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 20 May 2025
- Phase
- Observational
- 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
Study population: Any caregiver who, within their department, must take charge of the complex care of patients with EBH (nurse, caregiver, pediatric nurse, childcare assistant) is eligible.
Who may be able to join
- Nurse, nursing assistant, nursery nurse, childcare assistant, state graduates caring for patients with EBH and working at Necker Hospital.
- Having participated in the entire training program specific to the complex care of epidermolysis bullosa.
- Informed and not opposed to their participation in research.
Who cannot join
- Person under tutorship or curatorship.
- Other health professionals (physiotherapist, doctor, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Hereditary epidermolysis bullosa (EBH) is a rare, orphan disease characterized by skin and mucous membrane fragility.
The latest scientific data show that the proposed treatments are still in the experimental stage and that no curative treatment is available. The repercussions of this chronic disease, with neonatal onset, are major.
Read more
Epidermolysis bullosa requires multidisciplinary medical management, nursing care, psychological and social care.
Skin care involves preventing and treating chronic wounds and identifying their complications. The very great cutaneous-mucous fragility makes these treatments painful, long and complex, the caring hand itself being able to cause new wounds. Analgesics of different levels are not effective enough during treatment.
Along with counseling and education, nursing takes a central role in multi-professional accompaniment interventions to support and relieve families.
Parents became home caregivers out of necessity, and developed specific skills in epidermolysis bullosa, their child and dressings. They have great and demanding expectations of caregivers facing this rare disease, for which they are not trained in their degree course. Despite the severe nature of the disease, few studies have been carried out on the impact and psychosocial consequences on patients and their families, yet there is an expressed need for support.
The burden on parents is heavy, assessed by specific scales, but to date there are no studies examining the impact of epidermolysis bullosa care on caregiver stress.
- Conditions
- Hereditary Epidermolysis Bullosa
- Being tested
- Complex Care Training of Hereditary Epidermolysis Bullosa
- Keywords
- hereditary epidermolysis bullosa, nursing care, care training, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Care Training of Hereditary Epidermolysis BullosaBehavioural
Training in the care of epidermolysis bullosa by combining theoretical content on the disease and practical workshops.
| Study group | Role | What they receive |
|---|---|---|
| Nurse | Pediatric nurses taking charge of the care of patients with epidermolysis bullosa at Necker Hospital Receives: Behavioral: Complex Care Training of Hereditary Epidermolysis Bullosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of anxiety level
Anxiety will be assessed using the Anxiety - Spielberger State self-quiz, rated from 20 to 80 (80 indicating maximum anxiety state).
Measured: Change form baseline (before training) and at the end of the second day of training
Secondary outcomes (5)
Anxiety evolution
Anxiety will be assessed using the Anxiety - Spielberger State self-quiz, rated from 20 to 80 (80 indicating maximum anxiety state).
Measured: 3 months after training
Anxiety auto-evaluation
Self-assessment of factors that may induce anxiety measured on a Likert Scale from 0 to 4 (4 indicating a factors induces an high level of anxiety)
Measured: Before training. 3 and 6 months after the training
Feeling of skills
Self-assessment of feeling of skills on Likert scales from 0 to 4 (4 indicating a factors induces an high level of anxiety)
Measured: Before training. 3 and 6 months after the training
Nurse knowledge about Epidermolysis bullosa
A true/false questionnaire with degree of certainty assessing knowledge about epidermolysis bullosa
Measured: Before and after the training. 3 and 6 months after the training
Satisfaction questionnaire
Satisfaction questionnaire on the quality and content of the training with a Likert scale ( 0 to 5; an higher score indicates better outcome) and open questions.
Measured: At the end of the second day of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Jun 2023
- Primary completion15 Nov 2023
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hereditary Epidermolysis BullosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sandrine COMPAIN, RN, Principal investigator, Necker Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248503
- Sponsor's protocol ID
- APHP211522
- Acronym
- FIREB
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ingen-Housz-Oro S, Blanchet-Bardon C. Épidermolyses bulleuses héréditaires. EMC - Dermatol-Cosmétologie. 1 févr 2004 ; 1(1) :2 18.
Chiaverini C, Bourrat E, Mazereeuw-Hautier J, Hadj-Rabia S, Bodemer C, Lacour JP. [Hereditary epidermolysis bullosa: French national guidelines (PNDS) for diagnosis and treatment]. Ann Dermatol Venereol. 2017 Jan;144(1):6-35. doi: 10.1016/j.annder.2016.07.016. Epub 2016 Dec 5. French.
PubMed 27931749Lustre A, Levé-Corset I, Leeuwin G, Launay C, Blondy MF, Michaud MT, et al. Soins infirmiers de l'épidermolyse bulleuse. Rev Fr Allergol Immunol Clin. 2001 ; 41(7) : 659-663.
Jérôme Palazzolo, Julie Arnaud, Anxiété et performance : de la théorie à la pratique, Annales Médico-psychologiques, revue psychiatrique, Elsevier, Volume 171, Issue 6, July 2013, Pages 382-388.
Bandura, A. Auto-efficacité. Le sentiment d'efficacité personnelle (Trad. J. Lecomte). Bruxelles : De Boeck. 2003.
Gadbois, C., Aides-soignantes et infirmières de nuit, conditions de travail et vie quotidienne, Paris : Etudes et Recherches, 1981.
Van Daele A., Le stress chez les médecins généralistes : une approche transactionnelle, In B. Gangloff (Ed.), satisfactions et souffrances au travail (60-67), Paris : l'Harmattan.
Verquerre R., Rusinek-Nisot, Etude du stress chez des infirmiers, In R.Jacob et R. Laflamme (Eds), Stress, santé et intervention au travail, (61-71), Québec : Presses Inter Universitaires.
Borteyrou X, Bruchon-Schweitzer M, Spielberger CD. [The French adaptation of the STAXI-2, C.D. Spielberger's State-trait anger expression inventory]. Encephale. 2008 Jun;34(3):249-55. doi: 10.1016/j.encep.2007.06.001. Epub 2007 Oct 10. French.
PubMed 18558145
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Complex Care Training of Hereditary Epidermolysis Bullosa on Caregiver Burden (FIREB)
- ClinicalTrials.gov ID
- NCT05248503
- Acronym / sponsor ID
- FIREB / APHP211522
- Conditions
- Hereditary Epidermolysis Bullosa
- Keywords
- hereditary epidermolysis bullosa, nursing care, care training, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 21 Feb 2022 (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.
Hereditary epidermolysis bullosa (EBH) is a rare, orphan disease characterized by skin and mucous membrane fragility.
The latest scientific data show that the proposed treatments are still in the experimental stage and that no curative treatment is available. The repercussions of this chronic disease, with neonatal onset, are major.
Epidermolysis bullosa requires multidisciplinary medical management, nursing care, psychological and social care.
Skin care involves preventing and treating chronic wounds and identifying their complications. The very great cutaneous-mucous fragility makes these treatments painful, long and complex, the caring hand itself being able to cause new wounds. Analgesics of different levels are not effective enough during treatment.
Along with counseling and education, nursing takes a central role in multi-professional accompaniment interventions to support and relieve families.
Parents became home caregivers out of necessity, and developed specific skills in epidermolysis bullosa, their child and dressings. They have great and demanding expectations of caregivers facing this rare disease, for which they are not trained in their degree course. Despite the severe nature of the disease, few studies have been carried out on the impact and psychosocial consequences on patients and their families, yet there is an expressed need for support.
The burden on parents is heavy, assessed by specific scales, but to date there are no studies examining the impact of epidermolysis bullosa care on caregiver stress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse | – | Behavioral: Complex Care Training of Hereditary Epidermolysis BullosaPediatric nurses taking charge of the care of patients with epidermolysis bullosa at Necker Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any caregiver who, within their department, must take charge of the complex care of patients with EBH (nurse, caregiver, pediatric nurse, childcare assistant) is eligible.
Key inclusion criteria (3 listed)
- Nurse, nursing assistant, nursery nurse, childcare assistant, state graduates caring for patients with EBH and working at Necker Hospital.
- Having participated in the entire training program specific to the complex care of epidermolysis bullosa.
- Informed and not opposed to their participation in research.
Key exclusion criteria (2 listed)
- Person under tutorship or curatorship.
- Other health professionals (physiotherapist, doctor, etc.).
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 |
|---|---|---|
| Complex Care Training of Hereditary Epidermolysis BullosaTraining in the care of epidermolysis bullosa by combining theoretical content on the disease and practical workshops. | Behavioural | Nurse |
Primary outcome
Change of anxiety level
Time frame: Change form baseline (before training) and at the end of the second day of training
Anxiety will be assessed using the Anxiety - Spielberger State self-quiz, rated from 20 to 80 (80 indicating maximum anxiety state).
5 secondary outcomes
Anxiety evolution
Time frame: 3 months after training
Anxiety auto-evaluation
Time frame: Before training. 3 and 6 months after the training
Feeling of skills
Time frame: Before training. 3 and 6 months after the training
Nurse knowledge about Epidermolysis bullosa
Time frame: Before and after the training. 3 and 6 months after the training
Satisfaction questionnaire
Time frame: At the end of the second day of training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- BackgroundIngen-Housz-Oro S, Blanchet-Bardon C. Épidermolyses bulleuses héréditaires. EMC - Dermatol-Cosmétologie. 1 févr 2004 ; 1(1) :2 18.
- Background: PubMed 27931749Chiaverini C, Bourrat E, Mazereeuw-Hautier J, Hadj-Rabia S, Bodemer C, Lacour JP. [Hereditary epidermolysis bullosa: French national guidelines (PNDS) for diagnosis and treatment]. Ann Dermatol Venereol. 2017 Jan;144(1):6-35. doi: 10.1016/j.annder.2016.07.016. Epub 2016 Dec 5. French.
- BackgroundLustre A, Levé-Corset I, Leeuwin G, Launay C, Blondy MF, Michaud MT, et al. Soins infirmiers de l'épidermolyse bulleuse. Rev Fr Allergol Immunol Clin. 2001 ; 41(7) : 659-663.
- BackgroundJérôme Palazzolo, Julie Arnaud, Anxiété et performance : de la théorie à la pratique, Annales Médico-psychologiques, revue psychiatrique, Elsevier, Volume 171, Issue 6, July 2013, Pages 382-388.
- BackgroundBandura, A. Auto-efficacité. Le sentiment d'efficacité personnelle (Trad. J. Lecomte). Bruxelles : De Boeck. 2003.
- BackgroundGadbois, C., Aides-soignantes et infirmières de nuit, conditions de travail et vie quotidienne, Paris : Etudes et Recherches, 1981.
- BackgroundVan Daele A., Le stress chez les médecins généralistes : une approche transactionnelle, In B. Gangloff (Ed.), satisfactions et souffrances au travail (60-67), Paris : l'Harmattan.
- BackgroundVerquerre R., Rusinek-Nisot, Etude du stress chez des infirmiers, In R.Jacob et R. Laflamme (Eds), Stress, santé et intervention au travail, (61-71), Québec : Presses Inter Universitaires.
- Background: PubMed 18558145Borteyrou X, Bruchon-Schweitzer M, Spielberger CD. [The French adaptation of the STAXI-2, C.D. Spielberger's State-trait anger expression inventory]. Encephale. 2008 Jun;34(3):249-55. doi: 10.1016/j.encep.2007.06.001. Epub 2007 Oct 10. French.
- 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.
Sandrine COMPAIN, RN principal investigator
Necker Hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Epidermolysis Bullosa, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of anxiety level (time frame: Change form baseline (before training) and at the end of the second day of training). 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 NCT05248503, which also lists 9 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 6 May 2026.