YMHJ
5709
S0002-8703(18)30180-7
10.1016/j.ahj.2018.06.004
The Authors
Declarations of interest: None.
Contributors: All authors have approved this manuscript.
Study Protocol
20-Apr-2018
RCT# NCT01826019.
Trial Design
Rationale and design of a cluster randomized trial of a multifaceted intervention in people with hypertension: The Heart Outcomes Prevention and Evaluation 4 (HOPE-4) Study
Jon-David Reid
Schwalm
MD, MSc, FRCP(C)
a
b
⁎
schwalj@mcmaster.ca
Tara
McCready
PhD
a
Pablo
Lamelas
MD
a
b
Hadi
Musa
MHK
a
Patricio
Lopez-Jaramillo
MD, PhD, FACP
d
e
Khalid
Yusoff
MBBs, Hon. D Med Sc., FRCP Edin., FRCP Glasg., FRCP Lond., FACC, Hon. FPCP, FIAS, FAMM, FASc
f
g
Martin
McKee
CBE, MD, DSc, MSc, FRCP, FRCPE, FRCPI, FFPH, FMedSci
h
Paul Anthony
Camacho
MD, MSc
d
i
Jose
Lopez-Lopez
PhD, MD, DDS
d
i
Fadhlina
Majid
j
Lehana
Thabane
PhD
c
Shofiqul
Islam
PhD
a
Salim
Yusuf
MD, DPHIL, MRCP
a
b
a
Population Health Research Institute, Hamilton, Ontario, Canada
Population Health Research Institute
Hamilton
Ontario
Canada
b
Department of Medicine, Division of Cardiology, McMaster University, Hamilton, Ontario, Canada
Department of Medicine, Division of Cardiology
McMaster University
Hamilton
Ontario
Canada
c
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Department of Health Research Methods, Evidence and Impact
McMaster University
Hamilton
Ontario
Canada
d
Research Institute, Fundación Oftalmológica de Santander, Floridablanca, Colombia
Research Institute, Fundación Oftalmológica de Santander
Floridablanca
Colombia
e
Masira Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia
Masira Institute, Medical School, Universidad de Santander
Bucaramanga
Colombia
f
Faculty of Medicine, Universiti Teknologi Majlis Amanah Rakyat, Kuala Lumpur, Malaysia
Faculty of Medicine, Universiti Teknologi Majlis Amanah Rakyat
Kuala Lumpur
Malaysia
g
Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur, Malaysia
Faculty of Medicine and Health Sciences
UCSI University
Kuala Lumpur
Malaysia
h
Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom
Department of Health Services Research and Policy
London School of Hygiene and Tropical Medicine
London
United Kingdom
i
Medical School, Universidad Autonoma de Bucaramanga, Bucaramanga, Colombia
Medical School, Universidad Autonoma de Bucaramanga
Bucaramanga
Colombia
j
Universiti Teknologi MARA, Kuala Lumpur, Malaysia
Universiti Teknologi MARA
Kuala Lumpur
Malaysia
⁎
Reprint requests: Dr. J-D Schwalm, Population Health Research Institute, McMaster University, Hamilton Health Sciences, DBCVSRI, 237 Barton St E, Hamilton, Ontario, Canada L8L 2X2.
Population Health Research Institute, McMaster University, Hamilton Health Sciences, DBCVSRI, 237 Barton St E
Hamilton
Ontario
L8L 2X2
Canada
Abstract
Background
Cardiovascular disease is the leading cause of death throughout the world, with the majority of deaths occurring in low- and middle-income countries. Despite clear evidence for the benefits of blood pressure reduction and availability of safe and low-cost medications, most individuals are either unaware of their condition or not adequately treated.
Objective
The primary objective of this study is to evaluate whether a community-based, multifaceted intervention package primarily provided by nonphysician health workers can improve long-term cardiovascular risk in people with hypertension by addressing identified barriers at the patient, health care provider, and health system levels.
Methods/design
HOPE-4 is a community-based, parallel-group, cluster randomized controlled trial involving 30 communities (1,376 participants) in Colombia and Malaysia. Participants ≥50 years old and with newly diagnosed or poorly controlled hypertension were included. Communities were randomized to usual care or to a multifaceted intervention package that entails (1) detection, treatment, and control of cardiovascular risk factors by nonphysician health workers in the community, who use tablet-based simplified management algorithms, decision support, and counseling programs; (2) free dispensation of combination antihypertensive and cholesterol-lowering medications, supervised by local physicians; and (3) support from a participant-nominated treatment supporter (either a friend or family member). The primary outcome is the change in Framingham Risk Score after 12 months between the intervention and control communities. Secondary outcomes including change in blood pressure, lipid levels, and Interheart Risk Score will be evaluated.
Significance
If successful, the study could serve as a model to develop low-cost, effective, and scalable strategies to reduce cardiovascular risk in people with hypertension.
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2018-06-22T03:43:57Z
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