Heart Outcomes Prevention and Evaluation 4

NCT01826019 | Completed Phase 4 DMC

• 1 other identifier: HOPE-4
• Study Type: interventional
• Target: 1,438
• Locations: 3 countries
• Sites: 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.

Conditions

Hypertension; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• The mean difference in change in Framingham Risk Score (FRS) between the intervention and control communities from baseline to 1 year.

  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.

  Undetermined - currently not initiated and is dependent on funding (CVD Phase).

Secondary Outcomes (11)

• Change in systolic BP (SBP) between the intervention and control communities at 6 and 12 months

  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

  Baseline to 6 months and 12 months (HT Phase)

• Change in HDL, LDL, total cholesterol, triglycerides, and glucose levels at 12 months

  Baseline to 1 year (HT Phase)

• Change in smoking status at 6 and 12 months

  Baseline to 6 months and 12 months (HT Phase)

• Change in IHRS at 6 and 12 months and ChRS at 12 months

  Baseline to 6 months and 12 months (HT Phase)

Other Outcomes (3)

• A descriptive analysis of the processes involved in the intervention

  Baseline to 1 year

• Qualitative feedback from participants, NPHWs, and supervising physicians

  Baseline to 1 year

• Health economic and quality of life evaluations (as available and appropriate).

  Baseline to 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control - Usual Care

OTHER

Participants in control communities will be referred to usual care.

Other: Usual Care

Interventions

Intervention OTHER

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.

Intervention

Usual Care OTHER

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.

Control - Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 hours apart

You may not qualify if:

• Refusal to Consent
• Actively involved in any study or heart health program that would compromise the protocol of HOPE-4
• Severe co-morbid condition with life expectancy \< 1 year
• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Population Health Research Institute: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Grand Challenges Canada: collaborator
• Global Alliance for Chronic Diseases (GACD): collaborator

Study Sites (4)

Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

Location

Population Health Research Institute

Hamilton, Ontario, L8L 2X2, Canada

Location

FOSCAL

Floridablanca, Santander Department, Colombia

Location

UniversitiTeknologi MARA (UiTM)

Sungai Buloh, Selangor, 47000, Malaysia

Location

Related Publications (3)

• Drakos A, McCready T, Lopez-Jaramillo P, Islam S, McKee M, Yusuf S, Schwalm JD. Relationship Between Social Support and Clinical Outcomes: An Evaluation of Participant-Nominated Treatment Supporters in the HOPE 4 Intervention. Circ Cardiovasc Qual Outcomes. 2024 Apr;17(4):e009342. doi: 10.1161/CIRCOUTCOMES.122.009342. Epub 2024 Mar 5.

  PMID: 38440889 DERIVED

• Schwalm JD, McCready T, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas P, Camacho PA, Majid F, Bangdiwala SI, Thabane L, Islam S, McKee M, Yusuf S. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2019 Oct 5;394(10205):1231-1242. doi: 10.1016/S0140-6736(19)31949-X. Epub 2019 Sep 2.

  PMID: 31488369 DERIVED

• Schwalm JR, McCready T, Lamelas P, Musa H, Lopez-Jaramillo P, Yusoff K, McKee M, Camacho PA, Lopez-Lopez J, Majid F, Thabane L, Islam S, Yusuf S. Rationale and design of a cluster randomized trial of a multifaceted intervention in people with hypertension: The Heart Outcomes Prevention and Evaluation 4 (HOPE-4) Study. Am Heart J. 2018 Sep;203:57-66. doi: 10.1016/j.ahj.2018.06.004. Epub 2018 Jun 22.

  PMID: 30015069 DERIVED

Related Links

• Population Health Research Institute

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2013
• First Posted: April 8, 2013
• Study Start: August 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

CA (2); CO (1); MY (1)