| Trial name or title |
Heart Outcomes Prevention and Evaluation 4 (HOPE‐4) |
| Methods |
Open‐label, parallel, cluster‐randomised controlled trial design |
| Participants |
HT Phase: at least 50 urban and rural communities in Canada, Colombia and Malaysia will be randomised to participate in an intensive CV risk detection and control program by NPHW or to care as usual for 12 months
CVD Phase: continuation and expansion of HT Phase to include at least 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
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 h apart
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| Interventions |
Intensive CV risk detection, counselling and follow‐up programme 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.
Comparator: usual care. Participants in control communities will be referred to usual care |
| Outcomes |
Primary outcomes
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, hospitalisations) 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))
Secondary outcomes
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 the costs of the suggested programmes (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)
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| Starting date |
August 2014 |
| Contact information |
Contact: Patricio Lopez‐Jaramillo, MD
jplopezj@gmail.com |
| Notes |
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