Condition category
Circulatory System
Date applied
24/08/2004
Date assigned
11/10/2004
Last edited
02/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Manel Pladevall

ORCID ID

Contact details

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

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 measures

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

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 d’Osona per a la Recerca i l’Educació Sanitàries [FORES]) (Spain)

Sponsor details

C/Francesc Pla
Vic
08500
Spain
+34 937027710
fores@hgv.es

Sponsor type

Research organisation

Website

http://www.foresosona.org/

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

corporate

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20823391

Publication citations

  1. 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.

Additional files

Editorial Notes