Heart Outcomes Prevention and Evaluation 4

NCT01826019 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1438

Last updated 2019-02-21

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01826019 on ClinicalTrials.gov