Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Population Health Research Institute | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Grand Challenges Canada | OTHER |
| Global Alliance for Chronic Diseases (GACD) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control - Usual Care | Other | Participants in control communities will be referred to usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Other | 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. |
| 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| A descriptive analysis of the processes involved in the intervention | Baseline to 1 year | |
| Qualitative feedback from participants, NPHWs, and supervising physicians | Baseline to 1 year | |
Inclusion Criteria:
Individuals (≥ 50 years) with at least ONE of the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jon-David Schwalm, MD, MSc | McMaster University and Hamilton Health Sciences Corp. | Principal Investigator |
| Salim Yusuf, MD, DPhil | McMaster University and Hamilton Health Sciences Corp. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simon Fraser University | Burnaby | British Columbia | V5A 1S6 | Canada | ||
| Population Health Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38440889 | Derived | Drakos A, McCready T, Lopez-Jaramillo P, Islam S, McKee M, Yusuf S, Schwalm JD. Relationship Between Social Support and Clinical Outcomes: An Evaluation of Participant-Nominated Treatment Supporters in the HOPE 4 Intervention. Circ Cardiovasc Qual Outcomes. 2024 Apr;17(4):e009342. doi: 10.1161/CIRCOUTCOMES.122.009342. Epub 2024 Mar 5. | |
| 31488369 |
| Label | URL |
|---|---|
| Population Health Research Institute | View source |
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2023 | |
| Reset | Feb 21, 2024 | |
| Release | May 7, 2024 | |
| Reset | Sep 19, 2024 | |
| Release | May 7, 2026 | |
| Reset | Jun 2, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2023 | Feb 21, 2024 | |||
| May 7, 2024 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Usual Care | Other | 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. |
|
| 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) |
| Health economic and quality of life evaluations (as available and appropriate). |
We will collect data that will allow us to determine (i) the costs of the suggested programs (i.e. intervention package) and the costs of what is being provided currently for CVD assessment and management in the communities studied (i.e. control). |
| Baseline to 1 year |
| Hamilton |
| Ontario |
| L8L 2X2 |
| Canada |
| FOSCAL | Floridablanca | Santander Department | Colombia |
| UniversitiTeknologi MARA (UiTM) | Sungai Buloh | Selangor | 47000 | Malaysia |
| Schwalm JD, McCready T, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas P, Camacho PA, Majid F, Bangdiwala SI, Thabane L, Islam S, McKee M, Yusuf S. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2019 Oct 5;394(10205):1231-1242. doi: 10.1016/S0140-6736(19)31949-X. Epub 2019 Sep 2. |
| 30015069 | Derived | Schwalm JR, McCready T, Lamelas P, Musa H, Lopez-Jaramillo P, Yusoff K, McKee M, Camacho PA, Lopez-Lopez J, Majid F, Thabane L, Islam S, Yusuf S. Rationale and design of a cluster randomized trial of a multifaceted intervention in people with hypertension: The Heart Outcomes Prevention and Evaluation 4 (HOPE-4) Study. Am Heart J. 2018 Sep;203:57-66. doi: 10.1016/j.ahj.2018.06.004. Epub 2018 Jun 22. |
| Sep 19, 2024 |
| May 7, 2026 | Jun 2, 2026 |