Clinical trial NCT02817490: Patient Education Program and Ehlers-Danlos Syndrome
Official title: Evaluation of an Education Program for Patients With Hypermobility Type Ehlers-Danlos Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypermobility Type Ehlers-Danlos Syndrome
Keywords: hypermobility
Ehlers-Danlos Syndrome
patient education program
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 28
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: patients with hypermobility type Ehlers-Danlos Syndrome and their caregivers

Brief summary: The Ehlers-Danlos Syndrome (SED) comprises a group of clinically and genetically heterogeneous, inherited connective tissue diseases. The hypermobility type is the most frequent. It is characterized by a generalized joint hypermobility and a hyperextension skin.

Chronic pain syndrome is often present. Its psychological impact can be significant (anxiety, depression, impact on the quality of life of the patients). The disease also requires changes and a permanent adaptability (coping). It can lead to feelings of isolation and misunderstanding.

The French association of the Ehlers-Danlos Syndromes and the rehabilitation center of the 'Croix-Rouge Française des Massues' propose a patient education program for the patients with a hypermobility type SED (the PrEduSED program). This education program is open to patients and their caregivers located in France.

The research hypothesis is that the PrEduSED program improves their coping and reduces patient anxiety at 6 months (these are the two clinical criteria on which the PrEduSED could have the most impact, given the results of the first sessions).


Eligibility criteria: Inclusion Criteria:

Patients

* adults (\>18 years)
* hypermobility type Ehlers-Danlos Syndrome
* participating to one education session during the study period

Caregivers

* adults (\>18 years)
* caregivers of patients with hypermobility type Ehlers-Danlos Syndrome
* participating to one education session during the study period

Primary outcomes:
measure: Changes in scores obtained on the Coping Strategies Questionnaire-French version (CSQ-F)
timeFrame: Just before the education program (day 0) and 6 months after the education program (month 6)
Secondary outcomes:
measure: Changes in Hospital Anxiety And Depression Scale (HAD)
timeFrame: administered just before (day 0) and 6 months after the education program (month 6)
measure: Changes in a satisfaction questionnaire
timeFrame: administered just after the education program (day 4)
measure: Changes in a quiz
timeFrame: administered just before (day 0), after the education program (day 4) and 6 months after
measure: Changes in a Goal Attainment Scaling (GAS)
timeFrame: administered just before (day 0), after the education program (day 4)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
Study officials:
affiliation: Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
name: Sandrine TOUZET, MD
role: PRINCIPAL_INVESTIGATOR
References: