Heart Outcomes Prevention and Evaluation 4 (HOPE-4)
|Hypertension Cardiovascular Disease||Other: Intervention Other: Usual Care||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Official Title:||Heart Outcomes Prevention and Evaluation 4 (HOPE-4)|
- The mean difference in change in Framingham Risk Score (FRS) between the intervention and control communities from baseline to 1 year. [ Time Frame: 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. [ Time Frame: Baseline to 1 years CVD phase ]
- Change in systolic BP (SBP) between the intervention and control communities at 6 and 12 months [ Time Frame: 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 [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ]
- Change in HDL, LDL, total cholesterol, triglycerides, and glucose levels at 12 months [ Time Frame: Baseline to 1 year (HT Phase) ]
- Change in smoking status at 6 and 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ]
- Change in IHRS at 6 and 12 months and ChRS at 12 months [ Time Frame: 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 [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ]
- Medication adherence measures at 6 and 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ]
- Clinical events (e.g. death, CVD development, hospitalizations) at 6 and 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ]
- Country-specific process outcomes at 6 and 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ]
- Change in individual components of the primary outcomes in the HT Phase [ Time Frame: Baseline to 6 years (CVD Phase) ]
- Secondary outcomes from the HT Phase [ Time Frame: Baseline to 6 years (CVD Phase) ]
- A descriptive analysis of the processes involved in the intervention [ Time Frame: Baseline to 6 years ]
- Qualitative feedback from participants, NPHWs, and supervising physicians [ Time Frame: Baseline to 6 years ]
- Health economic and quality of life evaluations (as available and appropriate). [ Time Frame: Baseline to 6 years ]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).
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||August 2020|
|Estimated Primary Completion Date:||August 2020 (Final data collection date for primary outcome measure)|
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.
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.
Control - Usual Care
Participants in control communities will be referred to usual care.
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.
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.
CVD Phase: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01826019
|Contact: Tara L McCready, PhD, MBA||905-527-4322 ext firstname.lastname@example.org|
|Canada, British Columbia|
|Simon Fraser University||Recruiting|
|Burnaby, British Columbia, Canada, V5A 1S6|
|Principal Investigator: Scott Lear, PhD|
|Population Health Research Institute||Recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator: Jon-David Schwalm, MD, MSc|
|Floridablanca, Santander, Colombia|
|Contact: Patricio Lopez-Jaramillo, MD email@example.com|
|Contact: Paul Camacho-Lopez, MD firstname.lastname@example.org|
|UniversitiTeknologi MARA (UiTM)||Recruiting|
|Sungai Buloh, Selangor, Malaysia, 47000|
|Contact: Khalid Yusoff, MD VC@ucsiuniversity.edu.my|
|Contact: Fadhlina Ab Majid, MSc email@example.com|
|Principal Investigator:||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.|