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Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

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ClinicalTrials.gov Identifier: NCT01826019
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Grand Challenges Canada
Global Alliance for Chronic Diseases (GACD)
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Tracking Information
First Submitted Date  ICMJE March 31, 2013
First Posted Date  ICMJE April 8, 2013
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • 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). ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
  • The mean difference in change in systolic blood pressure (BP) between the intervention and control communities from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT phase) ]
  • Difference in number of a composite of major CV events (CV death, myocardial infarction (MI), stroke, congestive heart failure (CHF) and CV hospitalizations (unstable or new onset angina, CHF, or coronary revascularization) from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ]
Change History Complete list of historical versions of study NCT01826019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
  • The mean differences in calculated INTERHEART risk score from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT Phase) ]
  • The difference in the proportion of participants on antihypertensive treatment and well-controlled from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT Phase) ]
  • Difference in number of initiations, discontinuations, and up/down titrations of PolyCap formulations, as well as number of hospitalizations and CVD events from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT Phase) ]
  • Difference in the number of individual components of the primary outcome (CV death, MI, stroke, CHF and CV hospitalizations, unstable or new onset angina, CHF, or coronary revascularization) from baseline to 6 years. [ Time Frame: Baseline to 6 years (CVD Phase) ]
  • Mean difference in change in systolic BP from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ]
  • Mean difference in calculated lab and non-lab based INTERHEART Risk Score from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ]
  • Difference in number of initiations, discontinuations, and up/down titrations of PolyCap formulations from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ]
Current Other Pre-specified Outcome Measures
 (submitted: January 26, 2018)
  • 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). [ Time Frame: Baseline to 1 year ]
    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).
Original Other Pre-specified Outcome Measures
 (submitted: April 5, 2013)
Health economic evaluations - measure/calculate the unit costs and the quantity used of each of the components of the intervention and in usual care in the participating countries. [ 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).
 
Descriptive Information
Brief Title  ICMJE Heart Outcomes Prevention and Evaluation 4
Official Title  ICMJE Heart Outcomes Prevention and Evaluation 4 (HOPE-4)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Hypertension
  • Cardiovascular Disease
Intervention  ICMJE
  • Other: Intervention
    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.
  • 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 Arms  ICMJE
  • Experimental: Intervention
    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.
    Intervention: Other: Intervention
  • Control - Usual Care
    Participants in control communities will be referred to usual care.
    Intervention: Other: Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2018)
1438
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2013)
9500
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Individuals (≥ 50 years) with at least ONE of the following criteria:

  1. SBP ≥160 mmHg in one visit
  2. SBP 140-159 mmHg in one visit AND participant-reported medical diagnosis of hypertension
  3. SBP 140-159 mmHg in one visit AND participant taking anti-HT medication
  4. SBP ≥130 mmHg in one visit AND participant-reported medical diagnosis of diabetes
  5. SBP ≥130 mmHg in one visit AND participant taking medication for diabetes
  6. 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:

  1. Refusal to Consent
  2. Actively involved in any study or heart health program that would compromise the protocol of HOPE-4
  3. Severe co-morbid condition with life expectancy < 1 year
  4. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Colombia,   Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01826019
Other Study ID Numbers  ICMJE HOPE-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hamilton Health Sciences Corporation
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE
  • Population Health Research Institute
  • Canadian Institutes of Health Research (CIHR)
  • Grand Challenges Canada
  • Global Alliance for Chronic Diseases (GACD)
Investigators  ICMJE
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.
PRS Account Hamilton Health Sciences Corporation
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP