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| Name | Class |
|---|---|
| EVAMED | OTHER |
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Objective of this study is to assess the efficiency of NOVATEX MEDICAL compression garments in patients with an Ehlers-Danlos syndrome (EDS).
To answer this objectif a comparison before/after use of compression garments will be performed for all patients.
Inclusion period: 1 year Follow-up period: 26 months Study period : 38 months
Patient visits will be organized as follow:
Only the first two visits are specific to the study to be able to compare before and after the use of compression garments. Next visits are the usual visits (every 6 months) for the use of compression garments in patients with an EDS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Before and after use of compression garments | Other | At inclusion, patients will only have medication prescription as usual but without compression garments, and thus, for 4 months. 4 months after inclusion, patients will continue medication but will also be prescribed compression garments Then every 6 months, until 26 months, patients will come back to have new compression garments (as usual practice) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression garments | Device | Patients will wear the compression garments since 4 months after inclusion in order to have a comparison before and after use. Usual practice would give to the patient the compression garments at inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Functional Independence Measure (FIM) scale from 4 months at 8 months | Functional Independence Measure (FIM) is an 18- Item of physical, psychological and social function. The FIM uses the level of assistance an individual needs to grade the functional status of a person. For each item, disability level is coded from 1 (Total Assistance or not Testable) to 7 (Complete Independence) A total score is calculated using an addition of all items. Thus, score ranges are [18;126]. More the score is high, better is the independence. The proportion of patients who present an improvement of 10% of the FIM score between 4 months and 8 months will be calculated. | month 4, month 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient characteristics | Describe the characteristics of included patients: age, gender, height, weight, profession, Ehlers-Danlos Syndrom type | Inclusion |
| Relative improvement of Functional Independence Measure (FIM) scale at 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland Jaussaud, Prof. | Hôpitaux de Brabois - CHRU de Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Médical ISM | Boulogne-Billancourt | 92100 | France | |||
| CHU de CAEN |
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| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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Comparison before/after
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Functional Independence Measure (FIM) is an 18- Item of physical, psychological and social function.
The FIM uses the level of assistance an individual needs to grade the functional status of a person.
For each item, disability level is coded from 1 (Total Assistance or not Testable) to 7 (Complete Independence) A total score is calculated using an addition of all items. Thus, score ranges are [18;126]. More the score is high, better is the independence.
The FIM score at 8 months will be compared to the FIM score at 4 months.
| month 4, month 8 |
| Evolution of Functional Independence Measure (FIM) scale at long-term from inclusion at 14 months, 20 months and 26 months | Functional Independence Measure (FIM) is an 18- Item of physical, psychological and social function. The FIM uses the level of assistance an individual needs to grade the functional status of a person. For each item, disability level is coded from 1 (Total Assistance or not Testable) to 7 (Complete Independence) A total score is calculated using an addition of all items. Thus, score ranges are [18;126]. More the score is high, better is the independence. The FIM score will be described at each visit and if relevant, compared to FIM score at inclusion | Inclusion, month 14, month 20, month 26 |
| Evolution of Pain (before and after compression garments using) | Pain evolution using the VAS scale (from 0=no pain to 100=worst imaginable pain) The pain VAS is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For each visit, proportion of patients who present a decrease of at least 30% of pain score from inclusion, or a pain score <= 2, will be calculated. | Inclusion, month 4, month 8, month 14, month 20, month 26 |
| Evolution of Tiredness from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months) | Tiredness evolution using Pichot scale Eight items are coded from 0 to 4 (0 = not at all, 1 = a little 2 = moderately 3 = much 4 = extremely). Lower is the score, better is the patient tiredness For each visit, proportion of patients who present a decrease of at least 30% of Pichot score from inclusion, or a pichot score < 20, will be calculated. | Inclusion, month 4, month 8, month 14, month 20, month 26 |
| Evolution of Anxiety and depression from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months) | Evolution using the HAD scale (Hospital Anxiety and Depression scale) 14 items are included in this scale divided in two sub-scores (7 for assessment of the depression and 7 for the assessment of anxiety). A total score is also calculated. Lower is the score, better is the patient status For each visit, proportion of patients who present a decrease of at least 30% of HAD score from inclusion, or a HAD score < 14, will be calculated. | Inclusion, month 4, month 8, month 14, month 20, month 26 |
| Evolution of Quality of Life from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months) | Evolution of the Quality of Life using the EQ-5D-3L scale This scale is composed of 5 items with 3 levels from 1 to 3. Based on these levels, an index can be calculated from 0 to 1. Higher is the score, better is the patient status For each visit, proportion of patients who present an improvement of at least 0.10 of index from inclusion will be calculated. | Inclusion, month 4, month 8, month 14, month 20, month 26 |
| Evolution of the Use of concomitant medication from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months) | Assess the decreasing of use of concomitant medication The proportion of patient who present a decreasing of concomitant medication will be calculated at each visit. | Inclusion, month 4, month 8, month 14, month 20, month 26 |
| Evolution of Compliance | Compliance of compression garments wearing using a patient notebook Proportion of patients who are compliant with the compression garments wearing will be calculated at each visit. To be compliant is defined by a continuous or daily use | Month 8, month 14, month 20, month 26 |
| Compression garments safety | All adverse events related to the compression garments wearing from inclusion to 26 months will be presented and described | month 26 |
| Evolution of Patient satisfaction | Patient satisfaction regarding compression garments will be calculated at each visit using the following scale :
| month 8, month 14, month 20, month 26 |
| Caen |
| 14033 |
| France |
| Hopital Saint Joseph | Marseille | 13285 | France |
| Chu de Marseille - Hôpital de La Conception | Marseille | 13385 | France |
| Hôpital de L'Hotel Dieu - Aphp | Paris | 75004 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Hopital de La Croix Saint Simon | Paris | 75020 | France |
| CHU de REIMS | Reims | 51100 | France |
| CHU de SAINT QUENTIN | Saint-Quentin | 02321 | France |
| CHRU de NANCY | Vandœuvre-lès-Nancy | 54500 | France |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |