Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
COM 99
Study hypothesis
Added as of 01/12/2008:
The proposed study intervention to improve adherence to antihypertensive medication will improve both adherence to antihypertensive medication and the degree of blood pressure control. The better blood pressure control in the intervention group will result in a reduction of cardiovascular events.
Please note that, as of 01/12/2008, the start and end dates of this trial have been updated from 10/04/2000 and 05/05/2002 to 01/01/2000 and 01/12/2005, respectively.
Ethics approval
Institutional Review Board of the Hospital General de Vic (Spain), approved on 02/06/1999.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Arterial hypertension
Intervention
Usual clinical practice will be continued in patients assigned to the control group. The intervention to improve adherence to antihypertensive medications in the treatment group will include multi-level components (behavioral, cognitive, and social support). The clinical guidelines published by the World Health Organization (WHO) and the International Society of Hypertension (ISH) will be used to classify patients by their cardiovascular risk. The trial will be actively monitored to perform quality data assurance as well as external auditing.
Outcomes: Adherence to medications will be measured in both the control and intervention group using an electronically monitored pill container (EDEM®), which registers the date and time a pill is removed from the container. Blood pressure will be registered at each visit with a validated semiautomatic
sphygmomanometer (OMRON 705-CP). Primary outcomes will include blood pressure, adherence levels, and cardiovascular morbidity and mortality. Expected follow-up time is 5 years.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Mean SBP and DBP values obtained during office visit (measured at each visit with a semiautomatic sphygmomanometer (OMRON 705-CP). Main analysis will include blood pressure data until visit 3 (6 months).
Secondary outcome measures
1. Medication adherence according to MEMS (medication event monitoring system) device results. Medication adherence data will include information on the first 6 months (visit 3). Apart from recording the date and time each time the container is opened, the information from the electronic device may be downloaded to a computer for further statistical analysis.
2. Time elapsed until the first cardiovascular morbidity or mortality event during follow-up (expected follow-up duration: 5 years).
2.1. Fatal events ascribable to cardiovascular pathology. the following will be included: sudden heart failure; fatal myocardial infarction; death during/post percutaneous transluminal coronary angioplasty (PTCA) or aortocoronary bypass; death due to congestive heart failure; fatal CVA.
2.2. Non-fatal events ascribable to cardiovascular pathology. the following will be included: debutant congestive heart failure requiring hospitalization or chronic congestive heart failure requiring hospitalization; non-fatal acute myocardial infarction, as verified by a ST-segment peak in the ECG and/or typical enzyme pattern; emergency thrombolytic treatment/fibrinolytic treatment and/or emergency PTCA/aortocoronary bypass to prevent extensive myocardial infarction, as verified by a ST-segment peak in the ECG and/or typical enzyme pattern; CVA verified by CAT or hospital recordings; angina diagnosed with positive treadmill test results; routine PTCA/aortocoronary bypass; unstable angina requiring hospitalization; silent myocardial infarction detected during the study and not present in the ECGs prior to the beginning of the study; terminal renal insufficiency, impaired renal function.
Overall trial start date
01/01/2000
Overall trial end date
01/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
900 patients, aged 50 or older, presenting non-controlled systolic and/or diastolic hypertension, elevated cardiovascular risk (ten-year probability of a cardiovascular event ≥30%).
90 physicians from hospitals and primary care centers will be randomly allocated to the intervention or control group.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
900
Participant exclusion criteria
1. Participation in any investigational clinical trial within the past 3 months.
2. Incapacity or unwillingness to sign the informed consent.
Recruitment start date
01/01/2000
Recruitment end date
01/12/2005
Locations
Countries of recruitment
Spain
Trial participating centre
Center for Health Services Research - Henry Ford Health System
Detroit
MI 48202
United States of America
Sponsor information
Organisation
Osona Foundation for Research and Health Education (Fundació dOsona per a la Recerca i lEducació Sanitàries [FORES]) (Spain)
Sponsor details
C/Francesc Pla
Vic
08500
Spain
+34 937027710
fores@hgv.es
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Instituto de Salud Carlos III -Fondo de Investigación Sanitaria (Spanish Ministry of Health) (FIS00/0045-01 and FIS00/0045-02)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Catalan Agency for Health Technology Assessment and Research (AATM 02/24/98)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novartis (COM99)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
Funder name
Almirall Prodesfarma (COM99)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Aventis (COM99)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20823391
Publication citations
-
Results
Pladevall M, Brotons C, Gabriel R, Arnau A, Suarez C, de la Figuera M, Marquez E, Coca A, Sobrino J, Divine G, Heisler M, Williams LK, , Multicenter cluster-randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (the COM99 study)., Circulation, 2010, 122, 12, 1183-1191, doi: 10.1161/CIRCULATIONAHA.109.892778.