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Trial record 7 of 143 for:    warfarin AND therapeutic range

Pharmacist Interventions in Rural Elderly Warfarin Patients

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ClinicalTrials.gov Identifier: NCT03212898
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Slaven Falamić

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Thrombosis Cardiac Failure Hemorrhage Other: anticoagulation care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas
Actual Study Start Date : May 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Intervention
Specific pharmacist-led anticoagulation care
Other: anticoagulation care
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

No Intervention: Control
The control group will receive usual care; no interventions will be administered.



Primary Outcome Measures :
  1. Time in therapeutic range (TTR) [ Time Frame: 6 months ]
    Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212898


Sponsors and Collaborators
Slaven Falamić
Investigators
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Principal Investigator: Slaven Falamić, MPharm Pharmacy Branka Marušić

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Responsible Party: Slaven Falamić, Slaven Falamić,MPharm, Prinicipal-Investigator
ClinicalTrials.gov Identifier: NCT03212898     History of Changes
Other Study ID Numbers: SFalamic
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Slaven Falamić:
pharmacist interventions, warfarin, elderly rural patients
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Thrombosis
Heart Failure
Hemorrhage
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Anticoagulants