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Completed

NCT Number: NCT03212898

Pharmacist Interventions in Rural Elderly Warfarin Patients

The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiac Failure Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Heart Failure Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥65 years
  • Living site of participant outside the city eg. rural site
  • Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before

Exclusion criteria

  • Hospitalization
  • Vegetarianism
  • Patients not able to provide an informed consent
  • The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base

Treatment and study plan

anticoagulation care

Other

Patients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin

Primary outcomes

  1. Time in therapeutic range (TTR)

    Time frame: 6 months

    Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)

Secondary outcomes

  1. Adverse drug reactions

    Time frame: 6 months

    To measure the difference in number and types of adverse drug reactions between the intervention and the control group

  2. Time to adverse drug reaction

    Time frame: 6 months

    To measure the difference in time to adverse drug reactions between the intervention and the control group

  3. International randomised ratio

    Time frame: 6 months

    To measure the difference in patterns of the International randomised ratio between the intervention and the control group

  4. Adherence

    Time frame: 6 months

    To measure the difference in adherence between the intervention and the control group

  5. Quality of life

    Time frame: 6 months

    To measure the difference of the quality of life in the intervention and the control group at the beginning and the end of the study (validated Croatian version of DUKE - Duke anticoagulation satisfaction scale questionaire)

  6. Incidence and influence of clinically significant drug interactions

    Time frame: 6 months

    To measure the incidence of clinically significant drug interactions (defined by the Lexicomp-interact base as degree C and D of clinical significance) and influence of drug interactions on the effectiveness and safety of treatment between the intervention and the control group

  7. Dietary intake of vitamin K

    Time frame: 6 months

    Changes of dietary intake of vitamin K

  8. Acceptance of pharmacist's intervention by the general practitioners

    Time frame: 6 months

    To measure the rate of acceptance of pharmacist's interventions by the general practitioners

Sponsors and collaborators

Lead sponsor

Slaven Falamić

Other

Registry information

Official study title

The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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