Hypermobility Type Ehlers-Danlos SyndromePREDUSEDNCT02817490
Patient Education Program and Ehlers-Danlos Syndrome
An observational study of Hypermobility Type Ehlers-Danlos Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypermobility Type Ehlers-Danlos Syndrome
- What is being tested?
- patient education program
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with hypermobility type Ehlers-Danlos Syndrome and their caregivers
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
Lyon, 69424
About this study
Official title: 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.
Read more
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).
- Being tested
- patient education program
- Keywords
- hypermobility, Ehlers-Danlos Syndrome, patient education program
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient education programOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: patient education program | |
| Caregivers | Caregivers participating to one out of the three patient education sessions included in the study. Receives: Other: patient education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: administered just before (day 0) and 6 months after the education program (month 6)
Changes in a satisfaction questionnaire
It evaluates the reaction level of the Kirkpatrick model, the degree to which participants find the training favorable, engaging and relevant (level 1)
Measured: administered just after the education program (day 4)
Changes in a quiz
It evaluates the learning level of the Kirkpatrick model, the degree to which participants acquire the intended knowledge, skills, attitude (level 2)
Measured: administered just before (day 0), after the education program (day 4) and 6 months after
Changes in a Goal Attainment Scaling (GAS)
It evaluates the learning level of the Kirkpatrick model, the degree to which participants acquire the intended knowledge, skills, attitude (level 2)
Measured: administered just before (day 0), after the education program (day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startApr 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility Type Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine TOUZET, MD, Principal investigator, Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817490
- Sponsor's protocol ID
- D21775
- Acronym
- PREDUSED
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Education Program for Patients With Hypermobility Type Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT02817490
- Acronym / sponsor ID
- PREDUSED / D21775
- Keywords
- hypermobility, Ehlers-Danlos Syndrome, patient education program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hypermobility type Ehlers-Danlos Syndrome | – | Other: patient education programPatients with hypermobility type Ehlers-Danlos Syndrome participating to one out of the three patient education sessions included in the study. |
| Caregivers | – | Other: patient education programCaregivers participating to one out of the three patient education sessions included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hypermobility type Ehlers-Danlos Syndrome and their caregivers
Key inclusion criteria (8 listed)
- Patients
- adults (>18 years)
- hypermobility type Ehlers-Danlos Syndrome
- participating to one education session during the study period
- Caregivers
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient education programThe 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. | Other | Caregivers, Patients with hypermobility type Ehlers-Danlos Syndrome |
Primary outcome
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)
4 secondary outcomes
Changes in Hospital Anxiety And Depression Scale (HAD)
Time frame: 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)
Changes in a quiz
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
Related trials for Hypermobility Type Ehlers-Danlos Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine TOUZET, MD principal investigator
Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypermobility Type Ehlers-Danlos Syndrome, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.