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NCT Number: NCT02817490

Patient Education Program and 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).

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Key information

Conditions

Hypermobility Type Ehlers-Danlos Syndrome Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Ehlers-Danlos Syndrome Ehlers-Danlos syndrome type 3 Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon

Lyon, 69424, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient education program

Other

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PREDUSED

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 29, 2016
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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