Patient Education Program and Ehlers-Danlos Syndrome (PREDUSED)

study id #: NCT02817490

condition: Hypermobility Type Ehlers-Danlos Syndrome

status: completed

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).

intervention: Other: patient education program
The PREDUSED patient education program aims to make the patient actor of his pathology by providing him a "box of therapeutic tools" in order to: improve his knowledge of the disease, improve the management of pain, fatigue and episodes of instability; learn to communicate about the disease; set realistic goals.
The program includes theoretical information, practical cases, and discussions between participants and professionals.
It is the first patient education program in France for the patients with hypermobility type Ehlers-Danlos Syndrome. It is proposed two times a year. Six patients can participate at each session.

start date: April 2013

estimated completion: October 2015

last updated: June 29, 2016

phase of development: N/A

size / enrollment: 28

study design: Observational Model: Cohort
Time Perspective: Prospective

primary outcomes:

• Changes in scores obtained on the Coping Strategies Questionnaire-French version (CSQ-F) [ Time Frame:Just before the education program (day 0) and 6 months after the education program (month 6) ] The Coping Strategies Questionnaire-French version - CSQ-F measured the pain coping strategies through 21 items.It evaluates the behavioral level of the Kirkpatrick model

secondary outcomes:

• Changes in Hospital Anxiety And Depression Scale (HAD) [ Time Frame:administered just before (day 0) and 6 months after the education program (month 6) ] It contains 14 items. It evaluates the result level of the Kirkpatrick model, the degree to which targeted outcomes occur as a result of the training (level 4)
• Changes in a satisfaction questionnaire [ Time Frame:administered just after the education program (day 4) ] It evaluates the reaction level of the Kirkpatrick model, the degree to which participants find the training favorable, engaging and relevant (level 1)
• Changes in a quiz [ Time Frame:administered just before (day 0), after the education program (day 4) and 6 months after ] It evaluates the learning level of the Kirkpatrick model, the degree to which participants acquire the intended knowledge, skills, attitude (level 2)
• Changes in a Goal Attainment Scaling (GAS) [ Time Frame:administered just before (day 0), after the education program (day 4) ] It evaluates the learning level of the Kirkpatrick model, the degree to which participants acquire the intended knowledge, skills, attitude (level 2)

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

exclusion criteria:

sponsor: Hospices Civils de Lyon

investigators: Sandrine Touzet, MD Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon

locations: France