Patient Education Program and Ehlers-Danlos Syndrome

NCT02817490 | Completed

• 1 other identifier: D21775
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypermobility Type Ehlers-Danlos Syndrome

Keywords

hypermobility; Ehlers-Danlos Syndrome; patient education program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in Hospital Anxiety And Depression Scale (HAD)

  administered just before (day 0) and 6 months after the education program (month 6)

• Changes in a satisfaction questionnaire

  administered just after the education program (day 4)

• Changes in a quiz

  administered just before (day 0), after the education program (day 4) and 6 months after

• Changes in a Goal Attainment Scaling (GAS)

  administered just before (day 0), after the education program (day 4)

Study Arms (2)

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

Caregivers

Caregivers participating to one out of the three patient education sessions included in the study.

Other: patient education program

Interventions

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.

Caregivers; Patients with hypermobility type Ehlers-Danlos Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with hypermobility type Ehlers-Danlos Syndrome and their caregivers

You may qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon

Lyon, 69424, France

Location

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3; Ehlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Sandrine TOUZET, MD

  Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 29, 2016
• Study Start: April 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

FR (1)