Cardiovascular DiseasesNCT01449695
Intervention to Improve Medication Adherence in Cardiovascular Patients
A study testing Life style counseling, an individualized web portal and individual and group consultations in people with Cardiovascular Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate whether a nurse-based intervention, consisting of structural informative consulting and motivational counseling, on top of usual care with or without personalized web-based visualization of cardiovascular risk levels, improves the medication adherence in high risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Life style counseling, an individualized web portal and individual and group consultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Dec 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
- All subsequent patients, included in the hospital-screening program with manifestations of atherosclerotic disease (acute coronary syndrome, peripheral arterial disease or stroke/TIA) or elevated cardiovascular risk due to hypertension, diabetes or hyperlipidemia.
Who cannot join
- Age below 18 years, actual pregnancy, problems with Dutch language or logistic problems, which may hinder intervention on adherence behavior. Severe co-morbidity, including mental handicap, according to their physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients.
The purpose of this study is to investigate whether a nurse-based intervention, consisting of structural informative consulting and motivational counseling, on top of usual care with or without personalized web-based visualization of cardiovascular risk levels, improves the medication adherence in high risk cardiovascular patients.
Read the detailed description
Poor adherence to medication is one of the limitations in the treatment of cardiovascular disease. As a consequence the risk of premature death, hospital admissions and related costs is increasing. Therefore, detection of apparent poor adherence and interventions to improve adherence, are of great importance to enhance cardiovascular risk management over time.
This study is a prospective randomized trial, which compares 1) usual care with 2) the effect of a personalized visualization of cardiovascular risk levels (website) to support self management and 3) the additional effect of a communication intervention by a nurse on adherence on top of 2). Adherence is determined and continuously monitored with a dedicated calculation of refill data obtained from patient's pharmacy.
- Conditions
- Cardiovascular Diseases
- Being tested
- Life style counseling, an individualized web portal, individual and group consultations
- Keywords
- PAD, CVA, ACS
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life style counselingBehavioural
A nurse-based intervention with face-to-face contacts based on motivational interviewing techniques and influence on behavioral determinants. Well-trained nurses in our hospital will apply these behavioral change interventions. An individual contact will take about twenty minutes.
an individualized web portalBehavioural
This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors. These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient. The results of the screening and the two additional visits can be seen by the patient.
individual and group consultationsBehavioural
group consultations with peers and a nurse individual consultation with a nurse
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Group consultation and individual nurse consultation Receives: Behavioral: Life style counseling; Behavioral: an individualized web portal; Behavioral: individual and group consultations |
| e health | Experimental | An individual web based entry Receives: Behavioral: an individualized web portal |
| usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in degree of Adherence
The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data
Measured: Change from baseline in degree of Adherence at 12 month
Secondary outcomes (4)
Clinical outcome
Change in LDL-Cholesterol level in each group at 12 months from baseline
Measured: Change from baseline in level of LDL-Cholesterol at 12 months
Clinical outcome
Change in Systolic Blood Pressure in each group at 12 months from baseline
Measured: Change from baseline in Sytolic Blood Pressure at 12 months
Clinical outcome
Change in Body Mass Index (BMI) in each group at 12 months from baseline
Measured: Change from baseline in Body Mass Index at 12 months
Clinical outcome
Change in Waist Circumference in each group at 12 months from baseline
Measured: Change from baseline in Waist Circumference at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bas Bredie, Radboud University Medical Center
- Investigators
- Bas JH Bredie, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449695
- Sponsor's protocol ID
- 34338
- Status last verified
- Apr 2017
- First submitted
- 5 Oct 2011
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sieben A, van Onzenoort HA, van Dulmen S, van Laarhoven C, Bredie SJ. A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial. Patient Prefer Adherence. 2019 May 23;13:837-852. doi: 10.2147/PPA.S197481. eCollection 2019.
PubMed 31213778Sieben A, van Onzenoort HA, van Laarhoven KJ, Bredie SJ. A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the MIRROR Trial. JMIR Res Protoc. 2016 Sep 13;5(3):e187. doi: 10.2196/resprot.5750.
PubMed 27624877
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients.
- ClinicalTrials.gov ID
- NCT01449695
- Acronym / sponsor ID
- 34338
- Conditions
- Cardiovascular Diseases
- Keywords
- PAD, CVA, ACS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Oct 2011 (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.
The purpose of this study is to investigate whether a nurse-based intervention, consisting of structural informative consulting and motivational counseling, on top of usual care with or without personalized web-based visualization of cardiovascular risk levels, improves the medication adherence in high risk cardiovascular patients.
Detailed description
Poor adherence to medication is one of the limitations in the treatment of cardiovascular disease. As a consequence the risk of premature death, hospital admissions and related costs is increasing. Therefore, detection of apparent poor adherence and interventions to improve adherence, are of great importance to enhance cardiovascular risk management over time.
This study is a prospective randomized trial, which compares 1) usual care with 2) the effect of a personalized visualization of cardiovascular risk levels (website) to support self management and 3) the additional effect of a communication intervention by a nurse on adherence on top of 2). Adherence is determined and continuously monitored with a dedicated calculation of refill data obtained from patient's pharmacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Life style counseling, Behavioral: an individualized web portal, Behavioral: individual and group consultationsGroup consultation and individual nurse consultation |
| e health | Experimental | Behavioral: an individualized web portalAn individual web based entry |
| usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subsequent patients, included in the hospital-screening program with manifestations of atherosclerotic disease (acute coronary syndrome, peripheral arterial disease or stroke/TIA) or elevated cardiovascular risk due to hypertension, diabetes or hyperlipidemia.
Key exclusion criteria (1 listed)
- Age below 18 years, actual pregnancy, problems with Dutch language or logistic problems, which may hinder intervention on adherence behavior. Severe co-morbidity, including mental handicap, according to their physician.
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 |
|---|---|---|
| Life style counselingA nurse-based intervention with face-to-face contacts based on motivational interviewing techniques and influence on behavioral determinants. Well-trained nurses in our hospital will apply these behavioral change interventions. An individual contact will take about twenty minutes. | Behavioural | Lifestyle counseling |
| an individualized web portalThis website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors. These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient. The results of the screening and the two additional visits can be seen by the patient. | Behavioural | Lifestyle counseling, e health |
| individual and group consultationsgroup consultations with peers and a nurse individual consultation with a nurse | Behavioural | Lifestyle counseling |
Primary outcome
Change in degree of Adherence
Time frame: Change from baseline in degree of Adherence at 12 month
The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data
4 secondary outcomes
Clinical outcome
Time frame: Change from baseline in level of LDL-Cholesterol at 12 months
Clinical outcome
Time frame: Change from baseline in Sytolic Blood Pressure at 12 months
Clinical outcome
Time frame: Change from baseline in Body Mass Index at 12 months
Clinical outcome
Time frame: Change from baseline in Waist Circumference at 12 months
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 5 Apr 2017.
- Derived from this study: PubMed 31213778Sieben A, van Onzenoort HA, van Dulmen S, van Laarhoven C, Bredie SJ. A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial. Patient Prefer Adherence. 2019 May 23;13:837-852. doi: 10.2147/PPA.S197481. eCollection 2019.
- Derived from this study: PubMed 27624877Sieben A, van Onzenoort HA, van Laarhoven KJ, Bredie SJ. A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the MIRROR Trial. JMIR Res Protoc. 2016 Sep 13;5(3):e187. doi: 10.2196/resprot.5750.
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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.
Bas JH Bredie, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life style counseling, an individualized web portal and individual and group consultations in people with Cardiovascular Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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 5 Apr 2017. 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 Netherlands. 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?
Change in degree of Adherence (time frame: Change from baseline in degree of Adherence at 12 month). 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 NCT01449695, which also lists 2 linked publications.
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 5 Apr 2017.