A Phase 4 interventional study of Intervention and Usual Care in Hypertension and Cardiovascular Disease, sponsored by Hamilton Health Sciences Corporation. Completed at 4 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Hamilton Health Sciences Corporation · Phase 4, Interventional, and Health services research
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 1,438 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals (≥ 50 years) with at least ONE of the following criteria:
Exclusion Criteria:
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
Participants in control communities will be referred to usual care.
Other: Usual Care
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.
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.
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: Undetermined - currently not initiated and is dependent on funding (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: Undetermined - currently not initiated and is dependent on funding (CVD Phase)
Secondary outcomes from the HT Phase
Time frame: Undetermined - currently not initiated and is dependent on funding (CVD Phase)
A descriptive analysis of the processes involved in the intervention
Time frame: Baseline to 1 year
Qualitative feedback from participants, NPHWs, and supervising physicians
Time frame: Baseline to 1 year
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).
Time frame: Baseline to 1 year
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hamilton Health Sciences Corporation