Ischemic Attack, TransientNCT02089074
Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack
A study testing Drug use counselling in people with Ischemic Attack, Transient and Stroke, run by Norwegian University of Science and Technology at 6 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Attack, Transient, Stroke
- What is being tested?
- Drug use counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 6 sitesNorway
- Study dates
- Nov 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Ålesund Sykehus
Ålesund
Kristiansund Sykehus
Kristiansund
Levanger Sykehus
Levanger
Molde Sykehus
Molde
Namsos Sykehus
Namsos
St Olavs Hospital
Trondheim
About this study
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
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.
- Conditions
- Ischemic Attack, Transient, Stroke
- Being tested
- Drug use counselling
- Keywords
- Secondary Prevention, Pharmacists, Directive Counseling, Medication Adherence, Patient Compliance
- Medical subject headings
- Ischemic Attack, Transient, Stroke, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug use counsellingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| drug use counselling | Experimental | 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 Receives: Behavioral: Drug use counselling |
| Control group | No intervention | The patients in the control group receive no intervention just treatment and follow up according to national standards |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to drug treatment in secondary prevention after TIA
self reporting of adherence
Measured: 3 months
Secondary outcomes (9)
adherence to drug treatment in secondary prevention after TIA
self reporting of adherence
Measured: 1 year
Persistence
Persistence measured by control of filled prescriptions
Measured: 3 months
Incidence of stroke and cardiovascular events and deaths
Measured by using data from national health registries
Measured: 3 months
degree of disability or dependence in the daily activities
measured by modified Rankin Scale and indirectly by level of care
Measured: 3 months
patient satisfaction
Measured by using data from the Norwegian Stroke Registry
Measured: 3 months
Persistence
Persistence measured by control of filled prescriptions
Measured: 1 year
Incidence of stroke and cardiovascular events and deaths
Measured by using data from national health registries
Measured: 1 year
degree of disability or dependence in the daily activities
measured by modified Rankin Scale and indirectly by level of care
Measured: 1 year
patient satisfaction
Measured by using data from the Norwegian Stroke Registry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Attack, TransientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Midt-Norge, Sykehusapotekene i Midt Norge
- Responsible party
- Sponsor
- Investigators
- Bent Indredavik, PhD, Prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089074
- Sponsor's protocol ID
- 2012/1224a
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2014
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02089074
- Acronym / sponsor ID
- 2012/1224a
- Conditions
- Ischemic Attack, Transient, Stroke
- Keywords
- Secondary Prevention, Pharmacists, Directive Counseling, Medication Adherence, Patient Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Midt-Norge, Sykehusapotekene i Midt Norge
- Study start
- Nov 2012 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug use counselling | Experimental | Behavioral: Drug use counsellingPharmacist 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 |
| Control group | No intervention | –The patients in the control group receive no intervention just treatment and follow up according to national standards |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug use counselling | Behavioural | drug use counselling |
Primary outcome
adherence to drug treatment in secondary prevention after TIA
Time frame: 3 months
self reporting of adherence
9 secondary outcomes
adherence to drug treatment in secondary prevention after TIA
Time frame: 1 year
Persistence
Time frame: 3 months
Incidence of stroke and cardiovascular events and deaths
Time frame: 3 months
degree of disability or dependence in the daily activities
Time frame: 3 months
patient satisfaction
Time frame: 3 months
Persistence
Time frame: 1 year
Incidence of stroke and cardiovascular events and deaths
Time frame: 1 year
degree of disability or dependence in the daily activities
Time frame: 1 year
patient satisfaction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bent Indredavik, PhD, Prof study director
Norwegian University of Science and Technology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug use counselling in people with Ischemic Attack, Transient and Stroke, run by Norwegian University of Science and Technology at 6 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to drug treatment in secondary prevention after TIA (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.