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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01449695 |
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Date of registration:
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05/10/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intervention to Improve Medication Adherence in Cardiovascular Patients
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Scientific title:
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Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients. |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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420 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01449695 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Bas JH Bredie, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Intervention(s)
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Behavioral: an individualized web portal
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Behavioral: Life style counseling
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Behavioral: individual and group consultations
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Primary Outcome(s)
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Change in degree of Adherence
[Time Frame: Change from baseline in degree of Adherence at 12 month]
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Secondary Outcome(s)
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Clinical outcome
[Time Frame: Change from baseline in Body Mass Index at 12 months]
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Clinical outcome
[Time Frame: Change from baseline in level of LDL-Cholesterol at 12 months]
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Clinical outcome
[Time Frame: Change from baseline in Sytolic Blood Pressure at 12 months]
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Clinical outcome
[Time Frame: Change from baseline in Waist Circumference at 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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