Hypermobility Type Ehlers-Danlos Syndrome Clinical Trial
— PREDUSEDOfficial title:
Evaluation of an Education Program for Patients With Hypermobility Type Ehlers-Danlos Syndrome
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).
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in scores obtained on the Coping Strategies Questionnaire-French version (CSQ-F) | 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) |
Just before the education program (day 0) and 6 months after the education program (month 6) | No |
| Secondary | Changes in Hospital Anxiety And Depression Scale (HAD) | 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) | administered just before (day 0) and 6 months after the education program (month 6) | No |
| Secondary | Changes in a satisfaction questionnaire | It evaluates the reaction level of the Kirkpatrick model, the degree to which participants find the training favorable, engaging and relevant (level 1) | administered just after the education program (day 4) | No |
| Secondary | Changes in a quiz | It evaluates the learning level of the Kirkpatrick model, the degree to which participants acquire the intended knowledge, skills, attitude (level 2) | administered just before (day 0), after the education program (day 4) and 6 months after | No |
| Secondary | Changes in a Goal Attainment Scaling (GAS) | It evaluates the learning level of the Kirkpatrick model, the degree to which participants acquire the intended knowledge, skills, attitude (level 2) | administered just before (day 0), after the education program (day 4) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03359135 -
Compression Garments on Hypermobility Type of Ehlers-Danlos Syndrome (CGhEDS)
|
N/A |