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).

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).

MedLine Citation:	PMID: 20823391 Owner: NLM Status: MEDLINE
Abstract/OtherAbstract:	BACKGROUND: Medication nonadherence is common and results in preventable disease complications. This study assessed the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. METHODS AND RESULTS: In this multicenter, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥ 50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients' pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end point of all-cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62, 95% confidence interval 0.50 to 0.78) and were more likely to be adherent (odds ratio 1.91, 95% confidence interval 1.19 to 3.05) than control group patients at 6 months. After 5 years, 16% of the patients in the intervention group and 19% in the control group met the composite end point (hazard ratio 0.97, 95% confidence interval 0.67 to 1.39). CONCLUSIONS: A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events.

Authors:	Manel Pladevall; Carlos Brotons; Rafael Gabriel; Anna Arnau; Carmen Suarez; Mariano de la Figuera; Emilio Marquez; Antonio Coca; Javier Sobrino; George Divine; Michele Heisler; L Keoki Williams;
Publication Detail:	Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2010-09-07
Journal Detail:	Title: Circulation Volume: 122 ISSN: 1524-4539 ISO Abbreviation: Circulation Publication Date: 2010 Sep
Date Detail:	Created Date: 2010-09-21 Completed Date: 2010-10-07 Revised Date: 2012-04-26
Medline Journal Info:	Nlm Unique ID: 0147763 Medline TA: Circulation Country: United States
Other Details:	Languages: eng Pagination: 1183-91 Citation Subset: AIM; IM
Affiliation:	Center for Health Services Research, Henry Ford Hospital, One Ford Place 3A, Detroit, MI, USA. mpladev1@hfhs.org
Data Bank Information
Bank Name/Acc. No.:	ISRCTN/ISRCTN35208258
Export Citation:	APA/MLA Format Download EndNote Download BibTex
MeSH Terms
Descriptor/Qualifier:	Adult Antihypertensive Agents / therapeutic use* Blood Pressure / physiology* Cardiovascular Diseases / epidemiology* Female Follow-Up Studies Humans Hypertension / drug therapy, physiopathology Kaplan-Meier Estimate Longitudinal Studies Male Middle Aged Outcome Assessment (Health Care) Patient Compliance Patient Education as Topic Risk Factors Spain Treatment Outcome
Grant Support
ID/Acronym/Agency:	R01 DK064695-05/DK/NIDDK NIH HHS; R01 DK064695-06/DK/NIDDK NIH HHS; R01 DK064695-07/DK/NIDDK NIH HHS; R01 DK064695-08/DK/NIDDK NIH HHS; R01 HL079055-01A1/HL/NHLBI NIH HHS; R01 HL079055-02/HL/NHLBI NIH HHS; R01 HL079055-03/HL/NHLBI NIH HHS; R01 HL079055-04/HL/NHLBI NIH HHS; R01DK64695/DK/NIDDK NIH HHS; R01HL079055/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:	0/Antihypertensive Agents
Investigator
Investigator/Affiliation:	A Arnau / ; M Pladevall / ; C Brotons / ; A M Yáñez / ; A Leiva / ; M Terns / ; S Serrallach / ; M Serrarols / ; J Casanovas / ; J Modol / ; J Soler / ; J Llibre / ; J Plana / ; M J Adrián / ; M Domenech / ; J Vila / ; A Felip / ; A Pelegrí / ; M de la Figuera / ; E Vinyoles / ; E Castellote / ; L Comas / ; M Pladevall / ; J Feixas / ; V Canal / ; J Deniel / ; M Vilamú / ; S Martínez / ; A Moreta / ; M Tordera / ; I Puig / ; F Olivé / ; M A Gómez / ; E Márquez / ; J P Moreno / ; M A Casals / ; N de la Iglesia / ; C Brotons / ; J L Tovar / ; E Deig / ; E Llargués / ; N Del Val / ; M Cuxart / ; R Sans / ; T Gros / ; J Mallafré / ; F X Fulladosa / ; J M Galceran / ; R García / ; R Gabriel / ; L M Sánchez / ; C Del Arco / ; V F Gil / ; A Gómez / ; S Vega / ; E Navarro / ; D García / ; J M Martínez / ; D Mira / ; M A Navarro / ; J L Martínez / ; C De la Sen / ; M A Payá / ; M González / ; I Núñez / ; J Torregrosa / ; M Navarro / ; A García / ; P Horcajo / ; M Pérez / ; C Santos / ; F Durán / ; M L Ortega / ; L de la Rosa / ; I López / ; P Rodríguez / ; M Sánchez de Enciso / ; M E Gómez / ; I L Alvarez / ; M C López / ; E Alvarez / ; C Suárez / ; A González / ; M B Sierra / ; F J Cirujano / ; M L Barutell / ; B Novella / ; J L Antón / ; J Damián Garcés / ; I Blasco / ; J L Berenguer / ; I Montiel / ; G Permanyer / ; N Soriano / ; C Falces / ; P Roura /
Comments/Corrections
Comment In:	Circulation. 2010 Sep 21;122(12):1141-3 [PMID: 20823382 ]

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