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?

The effect of MDD on TTR during VKA treatment; a pragmatic parallel RCT.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27323

Enrollment

208

Registered

2016-05-30

Start date

2016-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin K-antagonist (VKA), Time in Therapeutic Range (TTR), Multidose Drug Dispensing (MDD), adherence

Interventions

Patients 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 Dispe

Eligibility

Inclusion criteria

Inclusion criteria: TTR 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 criteria

Exclusion criteria: Patients 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

Design outcomes

Primary

Measure	Time frame
delta 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

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

—

Contacts

Public ContactBram Mertens

SIR Institute for Pharmacy Practice and Policy

b.mertens@apotheekstevenshof.nltel: 0031 76 5766157

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)