Clinical Trial: Patient Education Program and Ehlers-Danlos Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Evaluation of an Education Program for Patients With Hypermobility Type Ehlers-Danlos Syndrome

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).


Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: 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, the degree to which participants apply what they learned during training (level 3)



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: June 24, 2016
Date Started: April 2013
Date Completion:
Last Updated: June 28, 2016
Last Verified: June 2016