Patient Education Program and Ehlers-Danlos Syndrome

Study Overview
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Brief Summary
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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).

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

Conditions
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Hypermobility Type Ehlers-Danlos Syndrome

Intervention / Treatment
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* Other: patient education program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hypermobility type Ehlers-Danlos Syndrome<br>Patients with hypermobility type Ehlers-Danlos Syndrome participating to one out of the three patient education sessions included in the study. | Other: patient education program<br>* 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.<br>|
| Caregivers<br>Caregivers participating to one out of the three patient education sessions included in the study. | Other: patient education program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypermobility, Ehlers-Danlos Syndrome, patient education program