Evaluation of an Education Program for Patients With Hypermobility Type Ehlers-Danlos Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Changes in scores obtained on the Coping Strategies Questionnaire-French version (CSQ-F)
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults (>18 years)
- •hypermobility type Ehlers-Danlos Syndrome
- •participating to one education session during the study period
- •adults (>18 years)
- •caregivers of patients with hypermobility type Ehlers-Danlos Syndrome
- •participating to one education session during the study period
Exclusion Criteria
- Not provided
Outcomes
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, the degree to which participants apply what they learned during training (level 3)
Secondary Outcomes
- Changes in a quiz(administered just before (day 0), after the education program (day 4) and 6 months after)
- Changes in a satisfaction questionnaire(administered just after the education program (day 4))
- Changes in Hospital Anxiety And Depression Scale (HAD)(administered just before (day 0) and 6 months after the education program (month 6))
- Changes in a Goal Attainment Scaling (GAS)(administered just before (day 0), after the education program (day 4))