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Patient Education Program and Ehlers-Danlos Syndrome (PREDUSED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date June 24, 2016
First Posted Date June 29, 2016
Last Update Posted Date June 29, 2016
Study Start Date April 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2016)
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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 28, 2016)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Education Program and Ehlers-Danlos Syndrome
Official Title Evaluation of an Education Program for Patients With Hypermobility Type Ehlers-Danlos Syndrome
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with hypermobility type Ehlers-Danlos Syndrome and their caregivers
Condition Hypermobility Type Ehlers-Danlos Syndrome
Intervention 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.

Study Groups/Cohorts
  • 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.
    Intervention: Other: patient education program
  • Caregivers
    Caregivers participating to one out of the three patient education sessions included in the study.
    Intervention: Other: patient education program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 28, 2016)
28
Original Actual Enrollment Same as current
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02817490
Other Study ID Numbers D21775
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Sandrine TOUZET, MD Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date June 2016