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Heart Outcomes Prevention and Evaluation 4 (HOPE-4)
The overall objective of the HOPE-4 Phases (HT and CVD) is to develop, implement and evaluate an evidence-based, contextually appropriate programme for cardiovascular disease (CVD) risk assessment, treatment and control involving: (1) simplified algorithms implemented by non-physician health workers (NPHW) and supported by e-health technologies (tablets programmed with decision and counselling support software); (2) initiation of evidence-based cardiovascular (CV) medications and (3) treatment supporters to optimize long-term medication and lifestyle adherence.
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.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Simon Fraser University
Burnaby, British Columbia, Canada
Population Health Research Institute
Hamilton, Ontario, Canada
FOSCAL
Floridablanca, Santander Department, Colombia
UniversitiTeknologi MARA (UiTM)
Sungai Buloh, Selangor, Malaysia
Start Date
August 1, 2014
Primary Completion Date
February 1, 2019
Completion Date
February 1, 2019
Last Updated
February 21, 2019
1,438
ACTUAL participants
Intervention
OTHER
Usual Care
OTHER
Lead Sponsor
Hamilton Health Sciences Corporation
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07241390