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Clinical Trials/NCT03154489
NCT03154489
Completed
Not Applicable

Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care

Universidad San Jorge1 site in 1 country204 target enrollmentMay 22, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anticoagulant
Sponsor
Universidad San Jorge
Enrollment
204
Locations
1
Primary Endpoint
Effectiveness of medication review with follow-up
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate the control of patients under treatment with coumarin anticoagulants, increasing their safety and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics and the SAME-TT2R2 is unexplored. Based on the foregoing, it seems necessary to study the impact of the Program of medication review with follow-up in collaboration with doctors and nurses in primary care improves the degree of control of the patients under treatment with coumarin anticoagulants. Method: a randomized, controlled study for the main objective. Population and scope of study: Patients on treatment with coumarin anticoagulants with time in therapeutic range (TTR) according to the method of Rosendaal less than 70% in follow-up from primary care in a health area of the Arrabal Health Center (Zaragoza, Spain). Each patient will be followed by a period of 6 months. After this period, patients in the control group (CG) will receive the service of medication review with follow-up for a period of time equivalent (6 months). Intervention: Program of pharmacotherapy follow-up. Variables result: Stability of the INR, drug adherence, intake of vitamin K, knowledge of the patient on the use of acenocoumarol, associated costs, avoided costs, quality of life, satisfaction of patients and professionals involved. Statistical analysis and sample size: 204 patients. Multivariate analysis will be used and cost-effectiveness..

Registry
clinicaltrials.gov
Start Date
May 22, 2017
End Date
September 22, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad San Jorge
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Submit a TTR less than 70% in the last 6 months.

Exclusion Criteria

  • Not sign the informed consent.
  • Present cognitive difficulties for the project.

Outcomes

Primary Outcomes

Effectiveness of medication review with follow-up

Time Frame: 6 months

Compare the effectiveness of medication review with follow-up in collaboration with doctors and nurses of primary care patients in treatment with anticoagulants coumarins against the usual practice used actually. Principally studying INR control of this patients during 6 months.

Secondary Outcomes

  • Quality of life related to health(6 months)
  • Study of patients habits(6 months)
  • Pharmacogenetic analysis of genes CYP2C9 and VKORC1, ApoE CYP4F2 in each patient(6 months)
  • Satisfaction in primary care professionals(6 months)
  • Review of clinical guidelines used in primary care(6 months)
  • Economic outcomes(6 months)

Study Sites (1)

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