Clinical trial NCT05248503: Impact of Complex Care Training of Hereditary Epidermolysis Bullosa on Caregiver Burden (FIREB)
Official title: Impact of Complex Care Training of Hereditary Epidermolysis Bullosa on Caregiver Burden (FIREB)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hereditary Epidermolysis Bullosa
Keywords: hereditary epidermolysis bullosa
nursing care
care training
child
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria

* Person under tutorship or curatorship.
* Other health professionals (physiotherapist, doctor, etc.).

Primary outcomes:
measure: Change of anxiety level
timeFrame: Change form baseline (before training) and at the end of the second day of training
Secondary outcomes:
measure: Anxiety evolution
timeFrame: 3 months after training
measure: Anxiety auto-evaluation
timeFrame: Before training. 3 and 6 months after the training
measure: Feeling of skills
timeFrame: Before training. 3 and 6 months after the training
measure: Nurse knowledge about Epidermolysis bullosa
timeFrame: Before and after the training. 3 and 6 months after the training
measure: Satisfaction questionnaire
timeFrame: At the end of the second day of training.
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Necker Hospital, APHP
name: Sandrine COMPAIN, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingen-Housz-Oro S, Blanchet-Bardon C. Épidermolyses bulleuses héréditaires. EMC - Dermatol-Cosmétologie. 1 févr 2004 ; 1(1) :2 18.
citation: 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.
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