Clinical trial NCT01826019: Heart Outcomes Prevention and Evaluation 4
Official title: Heart Outcomes Prevention and Evaluation 4 (HOPE-4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Cardiovascular Disease
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
name: Canadian Institutes of Health Research (CIHR)
name: Grand Challenges Canada
name: Global Alliance for Chronic Diseases (GACD)
First posted: 2013-04-08
Enrollment: 1438
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: The mean difference in change in Framingham Risk Score (FRS) between the intervention and control communities from baseline to 1 year.
timeFrame: Baseline to 1 year (HT phase)
measure: 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.
timeFrame: Undetermined - currently not initiated and is dependent on funding (CVD Phase).
Secondary outcomes:
measure: Change in systolic BP (SBP) between the intervention and control communities at 6 and 12 months
timeFrame: Baseline to 6 months and 12 months (HT Phase)
measure: 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
timeFrame: Baseline to 6 months and 12 months (HT Phase)
measure: Change in HDL, LDL, total cholesterol, triglycerides, and glucose levels at 12 months
timeFrame: Baseline to 1 year (HT Phase)
measure: Change in smoking status at 6 and 12 months
timeFrame: Baseline to 6 months and 12 months (HT Phase)
measure: Change in IHRS at 6 and 12 months and ChRS at 12 months
timeFrame: Baseline to 6 months and 12 months (HT Phase)
measure: 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
timeFrame: Baseline to 6 months and 12 months (HT Phase)
measure: Medication adherence measures at 6 and 12 months
timeFrame: Baseline to 6 months and 12 months (HT Phase)
measure: Clinical events (e.g. death, CVD development, hospitalizations) at 6 and 12 months
timeFrame: Baseline to 6 months and 12 months (HT Phase)
measure: Country-specific process outcomes at 6 and 12 months
timeFrame: Baseline to 6 months and 12 months (HT Phase)
measure: Change in individual components of the primary outcomes in the HT Phase
timeFrame: Undetermined - currently not initiated and is dependent on funding (CVD Phase)
measure: Secondary outcomes from the HT Phase
timeFrame: Undetermined - currently not initiated and is dependent on funding (CVD Phase)
Other outcomes:
measure: A descriptive analysis of the processes involved in the intervention
timeFrame: Baseline to 1 year
measure: Qualitative feedback from participants, NPHWs, and supervising physicians
timeFrame: Baseline to 1 year
measure: Health economic and quality of life evaluations (as available and appropriate).
timeFrame: Baseline to 1 year
Locations:
city: Burnaby
country: Canada
facility: Simon Fraser University
state: British Columbia
city: Hamilton
country: Canada
facility: Population Health Research Institute
state: Ontario
city: Floridablanca
country: Colombia
facility: FOSCAL
state: Santander
city: Sungai Buloh
country: Malaysia
facility: UniversitiTeknologi MARA (UiTM)
state: Selangor
Study officials:
affiliation: McMaster University and Hamilton Health Sciences Corp.
name: Jon-David Schwalm, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University and Hamilton Health Sciences Corp.
name: Salim Yusuf, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.