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

Primary Purpose

Ischemic Attack, Transient, Stroke

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Drug use counselling
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Attack, Transient focused on measuring Secondary Prevention, Pharmacists, Directive Counseling, Medication Adherence, Patient Compliance

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kristiansund Sykehus
  • Levanger Sykehus
  • Molde Sykehus
  • Namsos Sykehus
  • St Olavs Hospital
  • Ålesund Sykehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

drug use counselling

Control group

Arm Description

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

The patients in the control group receive no intervention just treatment and follow up according to national standards

Outcomes

Primary Outcome Measures

adherence to drug treatment in secondary prevention after TIA
self reporting of adherence

Secondary Outcome Measures

adherence to drug treatment in secondary prevention after TIA
self reporting of adherence
Persistence
Persistence measured by control of filled prescriptions
Incidence of stroke and cardiovascular events and deaths
Measured by using data from national health registries
degree of disability or dependence in the daily activities
measured by modified Rankin Scale and indirectly by level of care
patient satisfaction
Measured by using data from the Norwegian Stroke Registry
Persistence
Persistence measured by control of filled prescriptions
Incidence of stroke and cardiovascular events and deaths
Measured by using data from national health registries
degree of disability or dependence in the daily activities
measured by modified Rankin Scale and indirectly by level of care
patient satisfaction
Measured by using data from the Norwegian Stroke Registry

Full Information

First Posted
March 13, 2014
Last Updated
March 29, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Midt-Norge, Sykehusapotekene i Midt Norge
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1. Study Identification

Unique Protocol Identification Number
NCT02089074
Brief Title
Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Midt-Norge, Sykehusapotekene i Midt Norge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Attack, Transient, Stroke
Keywords
Secondary Prevention, Pharmacists, Directive Counseling, Medication Adherence, Patient Compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drug use counselling
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients in the control group receive no intervention just treatment and follow up according to national standards
Intervention Type
Behavioral
Intervention Name(s)
Drug use counselling
Primary Outcome Measure Information:
Title
adherence to drug treatment in secondary prevention after TIA
Description
self reporting of adherence
Time Frame
3 months
Secondary Outcome Measure Information:
Title
adherence to drug treatment in secondary prevention after TIA
Description
self reporting of adherence
Time Frame
1 year
Title
Persistence
Description
Persistence measured by control of filled prescriptions
Time Frame
3 months
Title
Incidence of stroke and cardiovascular events and deaths
Description
Measured by using data from national health registries
Time Frame
3 months
Title
degree of disability or dependence in the daily activities
Description
measured by modified Rankin Scale and indirectly by level of care
Time Frame
3 months
Title
patient satisfaction
Description
Measured by using data from the Norwegian Stroke Registry
Time Frame
3 months
Title
Persistence
Description
Persistence measured by control of filled prescriptions
Time Frame
1 year
Title
Incidence of stroke and cardiovascular events and deaths
Description
Measured by using data from national health registries
Time Frame
1 year
Title
degree of disability or dependence in the daily activities
Description
measured by modified Rankin Scale and indirectly by level of care
Time Frame
1 year
Title
patient satisfaction
Description
Measured by using data from the Norwegian Stroke Registry
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bent Indredavik, PhD, Prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Kristiansund Sykehus
City
Kristiansund
Country
Norway
Facility Name
Levanger Sykehus
City
Levanger
Country
Norway
Facility Name
Molde Sykehus
City
Molde
Country
Norway
Facility Name
Namsos Sykehus
City
Namsos
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
Ålesund Sykehus
City
Ålesund
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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