Heart Outcomes Prevention and Evaluation 4
NCT01826019 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1438
Last updated 2019-02-21
Summary
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.
Conditions
Interventions
- OTHER
-
Intervention
In intervention communities, management plans will be developed by the NPHW for all enrolled participants. The NPHWs will educate participants about CVD, HT treatment, lifestyle modifications and initiate therapy according to the modified WHO CVD risk-management algorithm, including referral of high-risk patients to physicians and safety monitoring where appropriate. Participants in intervention communities will have support from family or friends (treatment supporters) and will receive educational materials and treatment reminders using text-messaging, email, and printed materials, as appropriate for the participant and the community setting. Evidence-based CV medications will be made available to the NPHWs and supervising physicians for participant treatment.
- OTHER
-
Usual Care
At initial screening, eligible participants will be provided with a brief information booklet/leaflet (customized to the community or region) regarding lifestyle modification and be advised to see their usual physician for care that is considered appropriate. No structured interventions will be employed.
Sponsors & Collaborators
-
Population Health Research Institute
collaborator OTHER -
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Grand Challenges Canada
collaborator OTHER -
Global Alliance for Chronic Diseases (GACD)
collaborator OTHER -
Hamilton Health Sciences Corporation
lead OTHER
Principal Investigators
-
Jon-David Schwalm, MD, MSc · McMaster University and Hamilton Health Sciences Corp.
-
Salim Yusuf, MD, DPhil · McMaster University and Hamilton Health Sciences Corp.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2019-02-28
- Completion
- 2019-02-28
Countries
- Canada
- Colombia
- Malaysia
Study Locations
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