Impact of Early Debriefing and Enhanced Educative Components on Direct Oral Anticoagulant Adherence After Venous Thromboembolism.
NCT ID: NCT04141254
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2019-12-27
2021-12-31
Brief Summary
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In patients with an acute episode of VTE treated for at least 6 months, the main hypothesis is that early debriefing and educative components added to a standardized visit one month after an acute VTE has the potential to improve patient's adherence to APIXABAN therapy at 6 months of follow-up.
Detailed Description
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Design The "DEBRIEF-VTE" trial is a multicenter randomized trial with blind evaluation and using a Zelen randomization process comparing a standardized follow-up visit at one month associated with a "debriefing and enhanced educative components" versus a standardized follow-up visit at one month alone (i.e.; without debriefing process).
All patients meeting the inclusion and none of the exclusion criteria are eligible for randomization. They will be randomized 1:1 to one of two allocated groups:
* Experimental group: a standardized follow-up visit at one month associated with "debriefing and enhanced educative component"
* Control group: a standardized follow-up visit at one month alone (i.e.; without "debriefing and educative component") Randomization will be performed using a two-step methodology described by Zelen et al.
* Stratification by:
* Center
* DVT or PE
* Presence of a major risk factor (either transient or persistent) or not (unprovoked VTE) At visit 1 (inclusion, 0-7 days): Inclusion of patients using the first written informed consent to accept a standard follow-up (visit at 1 month and 6 months) without mentioning randomization at one month performed in order to allocate patients to have, or to not have, debriefing and enhanced educative components. Study medication will be administered with complete explanation about doses and a classical therapeutic information regarding DOAC and clinical signs of recurrent VTE and bleeding (one treatment box with 400 pills of apixaban at 5 mg for the first 6 months of therapy) will be performed.
Visit 2 (30 days):
* Before the visit 2, review of all the inclusion and exclusion criteria and compute creatinine clearance using Cockcroft-Gault method ; if all eligibility criteria are satisfied, randomization of the patient;
* After randomization, during the visit 2:
* For patients allocated to the experimental group: signature of the second written informed consent describing the debriefing and enhanced educative components and objective on quality of life
* For patients allocated to the control group: no second written informed consent is required
Visit 3/ET (180 days):
\- Evaluate quality of life (PembQOL if PE, VEINES-Qol if DVT, EQ-5D for all patients), residual symptoms (mMRC and MDP scale if PE, Villalta if DVT) depression (HAD), recurrent VTE, bleeding, hospitalizations, death
The primary objective is to demonstrate that, in patients with an acute episode of VTE treated for at least 6 months, early debriefing and enhanced educative components added to a standardized visit one month after an acute VTE is associated with an increased adherence to apixaban therapy at 6 months than after a standardized visit alone at one month (adherence measured by the MEMSCap™ Medication Event Monitoring System Cap (WestRock, USA \& Switzerland). In patients with an acute episode of VTE treated for at least 6 months, the main hypothesis is that early debriefing and educative components added to a standardized visit one month after an acute VTE has the potential to improve patient's adherence to APIXABAN therapy at 6 months of follow-up.
Secondary objectives are to evaluate the impact of early debriefing and enhanced educative components added to a standardized visit one month after an acute VTE on the following at 6 months of treatment : quality of life (EQ-5D for all, PembQOL if PE, VEINES-Qol if DVT), residual symptoms (MMRC and multidimensional dyspnea profile(MDP) scales if PE, Villalta if DVT), depression (HAD), recurrent VTE, bleeding,hospitalizations and death.
150 patients will be included Duration of the inclusion period: 18 months Duration of participation for each patient: 6 months Total duration of the study: 24 months
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Debriefing
a standardized follow-up visit at one month associated with "debriefing and enhanced educative component"
Debriefing and educative components
The patient will receive early debriefing and enhanced educative components added to a standardized visit at one month
Without debriefing
a standardized follow-up visit at one month alone (i.e.; without "debriefing and educative component")
Without debriefing and educative components
Patient will receive a standardized visit alone (without debriefing and enhanced educative components ) at one month
Interventions
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Debriefing and educative components
The patient will receive early debriefing and enhanced educative components added to a standardized visit at one month
Without debriefing and educative components
Patient will receive a standardized visit alone (without debriefing and enhanced educative components ) at one month
Eligibility Criteria
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Inclusion Criteria
* Patients with indications for a minimum of 6 months of anticoagulation after an acute documented VTE that was diagnosed 7 days ago or less (i.e.; symptomatic PE or proximal or distal DVT)
* Social security affiliation.
* Patient who signed inform consent form
Exclusion Criteria
* Unable or refusal to give informed consent
* Indication for anticoagulation other than DVT or PE (e.g.; atrial fibrillation, mechanic valves…)
* Treatment with investigational drug in the past 1 month
* Chronic liver disease or chronic hepatitis
* Renal insufficiency with creatinine \<30 ml / min on Cockcroft and Gault formula
* Known antiphospholipid syndrome
* Dual anti-platelet therapy or aspirin at dosage \>100 mg per day
* Concomitant use of a strong inhibitor of cytochrome P450 3A4 (CYP3A4) (e.g., a protease inhibitor for human immunodeficiency virus infection or azole-antimycotics agents ketoconazole, itraconazole, voriconazole, posaconazole) or a CYP3A4 inducer (e.g., rifampin, carbamazepine, or phenytoin),
* Active cancer of less than 6 months
* Active pregnancy or expected pregnancy in the next 6 months
* Planned surgery in the next 6 months
* No effective contraception in women of childbearing age
* Life expectancy \<6 months
* Patient with active clinically significant bleeding
* Patient with lesion or condition if considered a significant risk factor for major bleeding
* Patient with concomitant treatment with any other anticoagulant agent
* Patient with concomitant treatment as: P-gp inhibitors: ciclosporin, dronedarone, quinidine, verapamil, protease inhibitors (e.g.: ritonavir, nelfinavir, indinavir, saquinavir), macrolides (e.g.; erythromycin, clarithromycine), azole antifungals (e.g.; ketoconazole, itraconazole, voriconazole, posaconazole).
* Patient with concomitant treatment as non steroidal antiinflammatory drugs
* Patient with low body weight (\< 60kg).
* Patients with breast-feeding
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHU Angers
Angers, , France
HIA Brest
Brest, , France
CHRU de Brest
Brest, , France
CHU de Clermont Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, , France
APHP Hôpital Louis Mourier
Colombes, , France
CHU de Grenoble - Hôpital Nord Michallon
Grenoble, , France
HEGP
Paris, , France
CHU de Rennes - Hôpital Sud
Rennes, , France
CHU de Saint Etienne - Hôpital Nord
Saint-Etienne, , France
CHU de Toulouse - Hôpital de Rangueil
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Pierre-Marie ROY, PUPH
Role: primary
Claire ROUSSEAU, PH
Role: primary
Francis COUTURAUD, PhD
Role: primary
Anne-Sophie VEILLON
Role: backup
Jeannot SCHMIDT, PUPH
Role: primary
Isabelle MAHE, PH
Role: primary
Gilles PERNOD, PUPH
Role: primary
Olivier SANCHEZ, PUPH
Role: primary
Patrick JEGO
Role: primary
Laurent BERTOLETTI, PhD
Role: primary
Alessandra BURA RIVIERE, PUPH
Role: primary
Other Identifiers
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29BRC18.0198
Identifier Type: -
Identifier Source: org_study_id