Patient Education Program and Ehlers-Danlos Syndrome

Completed

• Conditions: Hypermobility Type Ehlers-Danlos Syndrome
• Interventions: Other: patient education program

• Registration Number: NCT02817490
• Lead Sponsor: Hospices Civils de Lyon

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-06
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-28
• Last Update Submitted: 2016-06-28
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caregivers	patient education program	Caregivers participating to one out of the three patient education sessions included in the study.
Patients with hypermobility type Ehlers-Danlos Syndrome	patient education program	Patients with hypermobility type Ehlers-Danlos Syndrome participating to one out of the three patient education sessions included in the study.

Primary Outcome Measures

Name	Time	Method
Changes in scores obtained on the Coping Strategies Questionnaire-French version (CSQ-F)	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 Outcome Measures

Name	Time	Method
Changes in a quiz	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 satisfaction questionnaire	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 Hospital Anxiety And Depression Scale (HAD)	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 Goal Attainment Scaling (GAS)	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)

Trial Locations

Locations (1)

Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon; 🇫🇷 Lyon, France