Multi-center cluster-randomised clinical trial to evaluate the efficacy of an intervention to improve anti-hypertensive medication adherence among patients with uncontrolled hypertension and high cardiovascular risk

ISRCTN	ISRCTN35208258
DOI	https://doi.org/10.1186/ISRCTN35208258
Protocol serial number	N/A
Sponsor	Osona Foundation for Research and Health Education (Fundació dOsona per a la Recerca i lEducació Sanitàries [FORES]) (Spain)
Funders	Instituto de Salud Carlos III -Fondo de Investigación Sanitaria (Spanish Ministry of Health) (FIS00/0045-01 and FIS00/0045-02), Catalan Agency for Health Technology Assessment and Research (AATM 02/24/98), Novartis (COM99), Almirall Prodesfarma (COM99), Aventis (COM99)

Submission date: 24/08/2004
Registration date: 11/10/2004
Last edited: 02/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Manel Pladevall
Scientific

Center for Health Services Research - Henry Ford Health System
1 Ford Place, Suite 3A
Detroit
MI 48202
United States of America

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	COM 99
Study objectives	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(s)	Institutional Review Board of the Hospital General de Vic (Spain), approved on 02/06/1999.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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.
Completion date	01/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	900
Key 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.
Key exclusion criteria	1. Participation in any investigational clinical trial within the past 3 months. 2. Incapacity or unwillingness to sign the informed consent.
Date of first enrolment	01/01/2000
Date of final enrolment	01/12/2005

Locations

Countries of recruitment

Spain
United States of America

Study participating centre

Center for Health Services Research - Henry Ford Health System

Detroit
MI 48202
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/09/2010		Yes	No