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What is the effect of packaging vitamin-K antagonists via Multidose Drug Dispensing compared to regular dispensing on the time in therapeutic range of patients under the supervision of the anticoagulation Clinic Leiden?


- candidate number24414
- NTR NumberNTR5883
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-mei-2016
- Secondary IDsP15.365, UPF1602 CME LUMC, UPPER UU
- Public TitleWhat is the effect of packaging vitamin-K antagonists via Multidose Drug Dispensing compared to regular dispensing on the time in therapeutic range of patients under the supervision of the anticoagulation Clinic Leiden?
- Scientific TitleThe effect of MDD on TTR during VKA treatment; a pragmatic parallel RCT.
- ACRONYM
- hypothesisPatients using vitamin K-antagonists are under intensive supervision of anticoagulation clinics in the Netherlands. Despite the supervision, not all patients achieve a time in therapeutic range above 65%. A proposed reason is a reduced adherence to the complex medication regime of VKA. Multidose Drug Dispensing can support the patient with their medication regime. What the effect on TTR is of Multidose Drug Dispensing is unknown. What is the effect packaging vitamin-K antagonists via Multidose Drug Dispensing compared to regular dispensing on the time in therapeutic range?
- Healt Condition(s) or Problem(s) studiedVitamin K antagonist, Pharmacokinetics, Pharmacokinetic interaction
- Inclusion criteriaTTR < 65% during last 6 months
> 64 years of age
> 4 chronic oral drugs
Lifelong indication for VKA
Vitamin-K antagonist use > 9 months
Patient or partner is responsible for medication
Informed consent
- Exclusion criteriaPatients with self-management of VKA medication
Patients with recurrent chemotherapy
Patient with palliative pain medication
Patients who receive home-care responsible for the administration of medication
Patients with VKA distributed via MDD
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate1-mrt-2017
- Target number of participants208
- InterventionsPatients with a low TTR (<65%) will be randomised to the intervention or control group. The intervention group will receive the medication, including the vitamin K-antagonist, via Multidose Drug Dispensing. The control group will receive the vitamin K-antagonist as the patient is used to (via regular dispensing).
- Primary outcomedelta TTR between the intervention and control group.

The delta TTR is the absolute difference in TTR six months before the study, and during the study period.
- Secondary outcome1. average number of vitamin K doses for uncontrolled INR
2. average number of control visits at Anticoagulation Clinic
3. average daily dose in the six months before the study and during the study period
4. intra-individual TTR
5. difference in MARS score
6. time above therapeutic range
7. time under therapeutic range
8. proportion of patients with thromboembolic events
9. proportion of patients with serious bleeding.
- TimepointsInclusion t=0
- TTR over the past six months using the method described by Rosendaal.
- BMQ, MARS, GFI, Mini-Cog, Questionnaire possible adherence problems

After six months t=1 (end of study)
- TTR over the past six months
- MARS
- average number of vitamin K doses
- average number of control visits at Anticoagulation Clinic
- proportion of patients with thromboembolic events
- proportion of patients with serious bleeding
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Bram Mertens
- CONTACT for SCIENTIFIC QUERIESMSc Bram Mertens
- Sponsor/Initiator SIR Institute for Pharmacy Practice and Policy
- Funding
(Source(s) of Monetary or Material Support)
Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie (KNMP) , Het platform GDS
- Publications
- Brief summaryThe effect of the Multidose Drug Dispensing (MDD) on health outcomes is unknown. Although the effect of MDD is unknown, MDD is frequently used in the Netherlands to support mostly the elderly with their medication. MDD can be used to improve patients adherence or support the patient with complex medications regimes. In this study the effect of MDD is investigated in patients using vitamin K-antagonists (VKA). Patients with VKA's are under the supervision of anticoagulation clinics in the Netherlands. Despite the strict supervision of anticoagulation clinics not all patients achieve a stable control of their INR expressed in the Time in Therapeutic Range (TTR). One possible explanation for the unstable control is reduced adherence to the complex dosing regimen of VKAís. In this study the effect of MDD on the TTR of patients with a TTR < 65 % will be investigated. Patients under the supervision of the Anticogulation Clinic Leiden with a TTR < 65% during the past six months will be invited to participate in the study. After informed consent patients are randomised to the intervention or control group. In the intervention group patient will receive the medication via MDD including the VKA. Patients in the control group will receive the vitamin K-antagonist as they are used to, via regular dispensing. After six months the TTR over the study period is determined and compared between the two groups. Itís estimated that patients receiving medication via MDD have an improved TTR compared to the control group.
The study starts at 01-6-2016 and 19 community pharmacies in the catchment area of the Anticoagulation Clinic Leiden participate in the study. The study is a collaboration between the SIR Institute for Pharmacy Practice and Policy, Utrecht University and the Anticoagulation Clinic Leiden.
- Main changes (audit trail)
- RECORD30-mei-2016 - 6-jul-2016


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