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Patient Education Program and Ehlers-Danlos Syndrome (PREDUSED)

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ClinicalTrials.gov Identifier: NCT02817490
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment
Hypermobility Type Ehlers-Danlos Syndrome Other: patient education program

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of an Education Program for Patients With Hypermobility Type Ehlers-Danlos Syndrome
Study Start Date : April 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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.
Other: patient education program

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.
Other: patient education program

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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with hypermobility type Ehlers-Danlos Syndrome and their caregivers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817490


Locations
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France
Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
Lyon, France, 69424
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sandrine TOUZET, MD Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02817490     History of Changes
Other Study ID Numbers: D21775
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016

Keywords provided by Hospices Civils de Lyon:
hypermobility
Ehlers-Danlos Syndrome
patient education program

Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases