StrokeNCT01684176
Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication
A study testing Complex tailored intervention in people with Stroke and Transient Ischemic Attack, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk of a new stroke, however, poor adherence to secondary prevention medications occurs frequently within this patient group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Complex tailored intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Patient admitted or receiving ambulatory treatment for an acute transient ischemic attack or ischemic stroke which has occurred within the previous 30 days.
- The patient or a carer usually dispenses the patient's medications
- Written consent
Who cannot join
- Cognitive or physical impairment that would preclude comprehension of a conversation
- Terminal illness
- Lives in a care home or an institution
- Receives dose dispensed medicine from a pharmacy
- Medicine is dispensed by a nurse in the patient's home
- Correctional mental health patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients
Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk of a new stroke, however, poor adherence to secondary prevention medications occurs frequently within this patient group. The purpose of this study is to evaluate whether a complex tailored pharmacist intervention will lead to increased adherence to secondary stroke prevention medications and less new stroke events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Complex tailored intervention, Usual care
- Keywords
- Stroke, Ischemic Attack, Transient, Medication adherence, Motivational interviewing, Stroke prevention
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex tailored interventionBehavioural
Usual careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Complex tailored intervention | Experimental | The intervention consists of 3 elements:
1. Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications.
2. Discharge consultation with an pharmacist using motivational interviewing techniques.
3. Follow-up telephone calls one week, two months and six months after discharge. Receives: Behavioral: Complex tailored intervention; Behavioral: Usual care |
| Usual care | Placebo comparator | Usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).
Measured: One year from inclusion
For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8)
Measured: 1 year from inclusion
Secondary outcomes (5)
Medication Adherence to antihypertensives measured by proportion of days covered (PDC)
Measured: One year from inclusion
Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives
Measured: One year from inclusion
Non-persistence with thromboprophylactic agents ( antiplatelets, anticoagulants, statins and antihypertensives) measured by percent of patients that are not supplied with medication for more than 3 continuous months
Measured: One year from inclusion
Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.
Measured: 3 months from discharge
Composite endpoint: stroke, myocardial infarction or cardiovascular death
Measured: One year from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Ulla Hedegaard, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684176
- Sponsor's protocol ID
- AKF-381
- Status last verified
- Jan 2015
- First submitted
- 10 Sep 2012
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hedegaard U, Kjeldsen LJ, Pottegard A, Bak S, Hallas J. Multifaceted intervention including motivational interviewing to support medication adherence after stroke/transient ischemic attack: a randomized trial. Cerebrovasc Dis Extra. 2014 Dec 11;4(3):221-34. doi: 10.1159/000369380. eCollection 2014 Sep-Dec.
PubMed 25598772
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients
- ClinicalTrials.gov ID
- NCT01684176
- Acronym / sponsor ID
- AKF-381
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- Stroke, Ischemic Attack, Transient, Medication adherence, Motivational interviewing, Stroke prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Sep 2012 (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.
Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk of a new stroke, however, poor adherence to secondary prevention medications occurs frequently within this patient group. The purpose of this study is to evaluate whether a complex tailored pharmacist intervention will lead to increased adherence to secondary stroke prevention medications and less new stroke events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex tailored intervention | Experimental | Behavioral: Complex tailored intervention, Behavioral: Usual careThe intervention consists of 3 elements: 1. Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications. 2. Discharge consultation with an pharmacist using motivational interviewing techniques. 3. Follow-up telephone calls one week, two months and six months after discharge. |
| Usual care | Placebo comparator | Behavioral: Usual careUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years or older
- Patient admitted or receiving ambulatory treatment for an acute transient ischemic attack or ischemic stroke which has occurred within the previous 30 days.
- The patient or a carer usually dispenses the patient's medications
- Written consent
Key exclusion criteria (6 listed)
- Cognitive or physical impairment that would preclude comprehension of a conversation
- Terminal illness
- Lives in a care home or an institution
- Receives dose dispensed medicine from a pharmacy
- Medicine is dispensed by a nurse in the patient's home
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 |
|---|---|---|
| Complex tailored intervention | Behavioural | Complex tailored intervention |
| Usual care | Behavioural | Complex tailored intervention, Usual care |
Primary outcome
Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).
Time frame: One year from inclusion
For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8)
Time frame: 1 year from inclusion
5 secondary outcomes
Medication Adherence to antihypertensives measured by proportion of days covered (PDC)
Time frame: One year from inclusion
Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives
Time frame: One year from inclusion
Non-persistence with thromboprophylactic agents ( antiplatelets, anticoagulants, statins and antihypertensives) measured by percent of patients that are not supplied with medication for more than 3 continuous months
Time frame: One year from inclusion
Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.
Time frame: 3 months from discharge
Composite endpoint: stroke, myocardial infarction or cardiovascular death
Time frame: One year from inclusion
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 21 Jan 2015.
- Background: PubMed 25598772Hedegaard U, Kjeldsen LJ, Pottegard A, Bak S, Hallas J. Multifaceted intervention including motivational interviewing to support medication adherence after stroke/transient ischemic attack: a randomized trial. Cerebrovasc Dis Extra. 2014 Dec 11;4(3):221-34. doi: 10.1159/000369380. eCollection 2014 Sep-Dec.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex tailored intervention in people with Stroke and Transient Ischemic Attack, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 6 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 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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?
Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC). (time frame: One year from inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684176, which also lists 1 linked publication.
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 21 Jan 2015.