Heart Outcomes Prevention and Evaluation 4

Study Overview
=================
Brief 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.

Official Title
-----------------
Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

Conditions
-----------------
Hypertension, Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: Intervention
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals (≥ 50 years) with at least ONE of the following criteria: SBP ≥160 mmHg in one visit SBP 140-159 mmHg in one visit AND participant-reported medical diagnosis of hypertension SBP 140-159 mmHg in one visit AND participant taking anti-HT medication SBP ≥130 mmHg in one visit AND participant-reported medical diagnosis of diabetes SBP ≥130 mmHg in one visit AND participant taking medication for diabetes 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: Refusal to Consent Actively involved in any study or heart health program that would compromise the protocol of HOPE-4 Severe co-morbid condition with life expectancy < 1 year 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: Intervention<br>* 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.<br>|
| Other: Control - Usual Care<br>Participants in control communities will be referred to usual care. | Other: Usual Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean difference in change in Framingham Risk Score (FRS) between the intervention and control communities from baseline to 1 year. |  | Baseline to 1 year (HT phase) | 
| Difference in major CV events [CV death, CV hospitalizations (e.g. MI, Stroke, AF, unstable or new onset angina, CHF, arterial revascularization), and end-stage renal disease] at 6 years. |  | Undetermined - currently not initiated and is dependent on funding (CVD Phase). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic BP (SBP) between the intervention and control communities at 6 and 12 months |  | Baseline to 6 months and 12 months (HT Phase) | 
| Proportion of participants with well-controlled blood pressure at 6 and 12 months (SBP < 140 mmHg in non-diabetics and SBP < 130 mmHg in diabetics |  | Baseline to 6 months and 12 months (HT Phase) | 
| Change in HDL, LDL, total cholesterol, triglycerides, and glucose levels at 12 months |  | Baseline to 1 year (HT Phase) | 
| Change in smoking status at 6 and 12 months |  | Baseline to 6 months and 12 months (HT Phase) | 
| Change in IHRS at 6 and 12 months and ChRS at 12 months |  | Baseline to 6 months and 12 months (HT Phase) | 
| Number of participants receiving prescriptions for (or taking) anti-hypertensive medications (as an indication of physician adherence to treatment guidelines) at 6 and 12 months |  | Baseline to 6 months and 12 months (HT Phase) | 
| Medication adherence measures at 6 and 12 months |  | Baseline to 6 months and 12 months (HT Phase) | 
| Clinical events (e.g. death, CVD development, hospitalizations) at 6 and 12 months |  | Baseline to 6 months and 12 months (HT Phase) | 
| Country-specific process outcomes at 6 and 12 months |  | Baseline to 6 months and 12 months (HT Phase) | 
| Change in individual components of the primary outcomes in the HT Phase |  | Undetermined - currently not initiated and is dependent on funding (CVD Phase) | 
| Secondary outcomes from the HT Phase |  | Undetermined - currently not initiated and is dependent on funding (CVD Phase) |