NCT01826019

Heart Outcomes Prevention and Evaluation 4

Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,438 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hypertension
• Cardiovascular Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2013-04-08
• Last updated: 2019-02-21

Locations

4 sites across 3 countries: Canada, Colombia, Malaysia