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Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Hamilton Health Sciences Corporation
Sponsor:
Collaborators:
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Grand Challenges Canada
Global Alliance for Chronic Diseases
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01826019
First received: March 31, 2013
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Hypertension
Cardiovascular Disease
Other: Intervention
Other: Usual Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change in HDL, LDL, total cholesterol, triglycerides, and glucose levels at 12 months [ Time Frame: Baseline to 1 year (HT Phase) ] [ Designated as safety issue: No ]
  • Change in smoking status at 6 and 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ] [ Designated as safety issue: No ]
  • Change in IHRS at 6 and 12 months and ChRS at 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Medication adherence measures at 6 and 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ] [ Designated as safety issue: No ]
  • Clinical events (e.g. death, CVD development, hospitalizations) at 6 and 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ] [ Designated as safety issue: No ]
  • Country-specific process outcomes at 6 and 12 months [ Time Frame: Baseline to 6 months and 12 months (HT Phase) ] [ Designated as safety issue: No ]
  • Change in individual components of the primary outcomes in the HT Phase [ Time Frame: Baseline to 6 years (CVD Phase) ] [ Designated as safety issue: No ]
  • Secondary outcomes from the HT Phase [ Time Frame: Baseline to 6 years (CVD Phase) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • A descriptive analysis of the processes involved in the intervention [ Time Frame: Baseline to 6 years ] [ Designated as safety issue: No ]
  • Qualitative feedback from participants, NPHWs, and supervising physicians [ Time Frame: Baseline to 6 years ] [ Designated as safety issue: No ]
  • Health economic and quality of life evaluations (as available and appropriate). [ Time Frame: Baseline to 6 years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 9500
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)
Arms Assigned Interventions
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.
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.
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.

Detailed Description:

Study design: open-label, parallel cluster randomized controlled trial design.

HT Phase: at least 50 urban and rural communities in Canada, Colombia and Malaysia will be randomized 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826019

Contacts
Contact: Tara L McCready, PhD, MBA 905-527-4322 ext 40439 tara.mccready@phri.ca

Locations
Canada, British Columbia
Simon Fraser University Recruiting
Burnaby, British Columbia, Canada, V5A 1S6
Principal Investigator: Scott Lear, PhD         
Canada, Ontario
Population Health Research Institute Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Jon-David Schwalm, MD, MSc         
Colombia
FOSCAL Recruiting
Floridablanca, Santander, Colombia
Contact: Patricio Lopez-Jaramillo, MD       jplopezj@gmail.com   
Contact: Paul Camacho-Lopez, MD       camacholopez.paul@gmail.com   
Malaysia
UniversitiTeknologi MARA (UiTM) Recruiting
Sungai Buloh, Selangor, Malaysia, 47000
Contact: Khalid Yusoff, MD       VC@ucsiuniversity.edu.my   
Contact: Fadhlina Ab Majid, MSc       fadhlina.majid@gmail.com   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Grand Challenges Canada
Global Alliance for Chronic Diseases
Investigators
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.
  More Information

Additional Information:
Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01826019     History of Changes
Other Study ID Numbers: HOPE-4 
Study First Received: March 31, 2013
Last Updated: April 12, 2016
Health Authority: Colombia: Ministry of Health and Social Protection
Malaysia: Ministry of Health

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016