Impact of Complex Care Training of Hereditary Epidermolysis Bullosa on Caregiver Burden (FIREB)

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Complex Care Training of Hereditary Epidermolysis Bullosa on Caregiver Burden (FIREB)

Conditions
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Hereditary Epidermolysis Bullosa

Intervention / Treatment
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* Behavioral: Complex Care Training of Hereditary Epidermolysis Bullosa


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nurse<br>Pediatric nurses taking charge of the care of patients with epidermolysis bullosa at Necker Hospital | Behavioral: Complex Care Training of Hereditary Epidermolysis Bullosa<br>* Training in the care of epidermolysis bullosa by combining theoretical content on the disease and practical workshops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change form baseline (before training) and at the end of the second day of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety evolution | Anxiety will be assessed using the Anxiety - Spielberger State self-quiz, rated from 20 to 80 (80 indicating maximum anxiety state). | 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) | 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) | 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 | 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. | At the end of the second day of training. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hereditary epidermolysis bullosa, nursing care, care training, child