- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02817490
Patient Education Program and Ehlers-Danlos Syndrome (PREDUSED)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69424
- Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with hypermobility type Ehlers-Danlos Syndrome
Patients with hypermobility type Ehlers-Danlos Syndrome participating to one out of the three patient education sessions included in the study.
|
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. |
Caregivers
Caregivers participating to one out of the three patient education sessions included in the study.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
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)
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)
|
administered just before (day 0) and 6 months after the education program (month 6)
|
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)
|
administered just after the education program (day 4)
|
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)
|
administered just before (day 0), after the education program (day 4) and 6 months after
|
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)
|
administered just before (day 0), after the education program (day 4)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandrine TOUZET, MD, Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Disease
- Congenital Abnormalities
- Hematologic Diseases
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Hemostatic Disorders
- Skin Diseases, Genetic
- Skin Abnormalities
- Collagen Diseases
- Syndrome
- Ehlers-Danlos Syndrome
Other Study ID Numbers
- D21775
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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