Completed

HOPE-4Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

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What is being tested

Intervention

+ Usual Care

Other
Who is being recruted

Vascular Diseases

+ Cardiovascular Diseases

+ Hypertension

Over 50 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Phase 4
Interventional
Study Start: August 2014
See protocol details

Summary

Principal SponsorHamilton Health Sciences Corporation
Last updated: February 21, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2014

Actual date on which the first participant was enrolled.

Study design: open-label, parallel cluster randomized controlled trial design. HT Phase: Up to 30 urban and rural communities in Canada, Colombia and Malaysia will be randomized to participate in an intensive CV risk detection and control programme by NPHW or to care as usual for 12 months. NOTE: Canada will serve as a pilot study, which will be used to evaluate feasibility, time, cost and program improvements. CVD Phase: If funded, this phase will be a continuation and expansion of HT Phase to include up to 190 urban and rural communities in countries within Asia, South America, Sub-Saharan Africa, and Canada that will be allocated to participate in an intensive CV risk detection and control programme supported by NPHWs or to care as usual for up to 6 years. NOTE: CVD Phase - currently not initiated. Communities will be randomized 1:1 with a central randomization system to either a) intervention or b) control, after screening in the community is complete.

NCT01826019
Principal SponsorHamilton Health Sciences Corporation
Last updated: February 21, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1438 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vascular DiseasesCardiovascular DiseasesHypertension

Criteria

Inclusion Criteria: Individuals (≥ 50 years) with at least ONE of the following criteria: SBP ≥160 mmHg in one visit SBP 140-159 mmHg in one visit AND participant-reported medical diagnosis of hypertension SBP 140-159 mmHg in one visit AND participant taking anti-HT medication SBP ≥130 mmHg in one visit AND participant-reported medical diagnosis of diabetes SBP ≥130 mmHg in one visit AND participant taking medication for diabetes Participants that do not meet criteria 1-5 AND SBP 140-159 mmHg in one visit AND SBP ≥140 mmHg in a second visit ≥24 hours apart Exclusion Criteria: Refusal to Consent Actively involved in any study or heart health program that would compromise the protocol of HOPE-4 Severe co-morbid condition with life expectancy < 1 year Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intensive CV risk detection, counselling and follow-up program by NPHW; recommended CV medications will include combinations of anti-hypertensive medications (both low and high doses) and a lipid lowering agent (e.g. statin) in accordance with treatment algorithm [precise formulations used may differ in each country]; use of treatment supporters to reinforce adherence.

Group II

Participants in control communities will be referred to usual care.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Simon Fraser University

Burnaby, CanadaOpen Simon Fraser University in Google Maps

Population Health Research Institute

Hamilton, Canada

FOSCAL

Floridablanca, Colombia

UniversitiTeknologi MARA (UiTM)

Sungai Buloh, Malaysia
Completed4 Study Centers