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Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089074
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
St. Olavs Hospital
Helse Midt-Norge
Sykehusapotekene i Midt Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Use of drugs is an important factor in secondary prophylaxis after transient ischemic attack (TIA), but studies show that adherence to the prescribed drugs is often poor. This randomised controlled trial aims to investigate whether a systematic follow up of drug treatment using medication reconciliation, medication reviews and patient counselling by clinical pharmacists, improves adherence and/or decreases cardiovascular events the first three months and the first year after TIA. Patient satisfaction will also be compared between the two groups.

Condition or disease Intervention/treatment Phase
Ischemic Attack, Transient Stroke Behavioral: Drug use counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack: Adherence and Cardiovascular Events in the First Three Months
Actual Study Start Date : November 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: drug use counselling
Pharmacist conducting drug reconciliation, medication reviews and drug use counselling during hospitalisation. Follow up telephone calls 1 week, 1 month, 2 months and three months after discharge from hospital
Behavioral: Drug use counselling
No Intervention: Control group
The patients in the control group receive no intervention just treatment and follow up according to national standards



Primary Outcome Measures :
  1. adherence to drug treatment in secondary prevention after TIA [ Time Frame: 3 months ]
    self reporting of adherence


Secondary Outcome Measures :
  1. adherence to drug treatment in secondary prevention after TIA [ Time Frame: 1 year ]
    self reporting of adherence

  2. Persistence [ Time Frame: 3 months ]
    Persistence measured by control of filled prescriptions

  3. Incidence of stroke and cardiovascular events and deaths [ Time Frame: 3 months ]
    Measured by using data from national health registries

  4. degree of disability or dependence in the daily activities [ Time Frame: 3 months ]
    measured by modified Rankin Scale and indirectly by level of care

  5. patient satisfaction [ Time Frame: 3 months ]
    Measured by using data from the Norwegian Stroke Registry

  6. Persistence [ Time Frame: 1 year ]
    Persistence measured by control of filled prescriptions

  7. Incidence of stroke and cardiovascular events and deaths [ Time Frame: 1 year ]
    Measured by using data from national health registries

  8. degree of disability or dependence in the daily activities [ Time Frame: 1 year ]
    measured by modified Rankin Scale and indirectly by level of care

  9. patient satisfaction [ Time Frame: 1 year ]
    Measured by using data from the Norwegian Stroke Registry



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Probable or possible transient ischemic attack
  • Residing in Central Norway
  • Examined within 2 weeks after the onset of symptoms
  • Modified Rankin Scale 3 or less and living at home
  • enrolled in the MIDNOR-TIA study NCT02038725
  • Informed consent

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): NCT02089074


Locations
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Norway
Kristiansund Sykehus
Kristiansund, Norway
Levanger Sykehus
Levanger, Norway
Molde Sykehus
Molde, Norway
Namsos Sykehus
Namsos, Norway
St Olavs Hospital
Trondheim, Norway
Ålesund Sykehus
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Helse Midt-Norge
Sykehusapotekene i Midt Norge
Investigators
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Study Director: Bent Indredavik, PhD, Prof Norwegian University of Science and Technology
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02089074    
Other Study ID Numbers: 2012/1224a
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 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 Norwegian University of Science and Technology:
Secondary Prevention
Pharmacists
Directive Counseling
Medication Adherence
Patient Compliance
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Ischemia
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases