Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

Hamilton Health Sciences (HHS)

Status and phase: Completed; Phase 4

Conditions: Hypertension; Cardiovascular Disease

Treatments: Other: Usual Care; Other: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01826019

HOPE-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,438 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Individuals (≥ 50 years) with at least ONE of the following criteria:

1. SBP ≥160 mmHg in one visit
2. SBP 140-159 mmHg in one visit AND participant-reported medical diagnosis of hypertension
3. SBP 140-159 mmHg in one visit AND participant taking anti-HT medication
4. SBP ≥130 mmHg in one visit AND participant-reported medical diagnosis of diabetes
5. SBP ≥130 mmHg in one visit AND participant taking medication for diabetes
6. 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

1. Refusal to Consent
2. Actively involved in any study or heart health program that would compromise the protocol of HOPE-4
3. Severe co-morbid condition with life expectancy < 1 year
4. 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,438 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Intervention

Control - Usual Care

Other group

Description:

Participants in control communities will be referred to usual care.

Treatment:

Other: Usual Care