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Completed

NCT Number: NCT01826019

Heart Outcomes Prevention and Evaluation 4

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.

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Key information

Conditions

Hypertension Cardiovascular Disease Cardiovascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Simon Fraser University, Burnaby, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 hours apart

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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).

Secondary outcomes

  1. 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)

  2. 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)

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

    Time frame: Baseline to 1 year (HT Phase)

  4. Change in smoking status at 6 and 12 months

    Time frame: Baseline to 6 months and 12 months (HT Phase)

  5. Change in IHRS at 6 and 12 months and ChRS at 12 months

    Time frame: Baseline to 6 months and 12 months (HT Phase)

  6. 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)

  7. Medication adherence measures at 6 and 12 months

    Time frame: Baseline to 6 months and 12 months (HT Phase)

  8. Clinical events (e.g. death, CVD development, hospitalizations) at 6 and 12 months

    Time frame: Baseline to 6 months and 12 months (HT Phase)

  9. Country-specific process outcomes at 6 and 12 months

    Time frame: Baseline to 6 months and 12 months (HT Phase)

  10. 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)

  11. Secondary outcomes from the HT Phase

    Time frame: Undetermined - currently not initiated and is dependent on funding (CVD Phase)

Other outcomes

  1. A descriptive analysis of the processes involved in the intervention

    Time frame: Baseline to 1 year

  2. Qualitative feedback from participants, NPHWs, and supervising physicians

    Time frame: Baseline to 1 year

  3. 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).

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Global Alliance for Chronic Diseases (GACD)
  • Grand Challenges Canada
  • Population Health Research Institute

Registry information

Official study title

Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

Acronym: HOPE-4

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2013
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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