Heart Outcomes Prevention and Evaluation 4

Hypertension Clinical Trial

— HOPE-4  

Official title:

Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826019
• Other study ID #: HOPE-4
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: February 2019

Study information

• Verified date: February 2019
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1438
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Simon Fraser University	Burnaby	British Columbia
Canada	Population Health Research Institute	Hamilton	Ontario
Colombia	FOSCAL	Floridablanca	Santander
Malaysia	UniversitiTeknologi MARA (UiTM)	Sungai Buloh	Selangor

Sponsors (5)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Canadian Institutes of Health Research (CIHR), Global Alliance for Chronic Diseases (GACD), Grand Challenges Canada, Population Health Research Institute

Countries where clinical trial is conducted

Canada,  Colombia,  Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	A descriptive analysis of the processes involved in the intervention		Baseline to 1 year
Other	Qualitative feedback from participants, NPHWs, and supervising physicians		Baseline to 1 year
Other	Health economic and quality of life evaluations (as available and appropriate).	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).	Baseline to 1 year
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Change in HDL, LDL, total cholesterol, triglycerides, and glucose levels at 12 months		Baseline to 1 year (HT Phase)
Secondary	Change in smoking status at 6 and 12 months		Baseline to 6 months and 12 months (HT Phase)
Secondary	Change in IHRS at 6 and 12 months and ChRS at 12 months		Baseline to 6 months and 12 months (HT Phase)
Secondary	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		Baseline to 6 months and 12 months (HT Phase)
Secondary	Medication adherence measures at 6 and 12 months		Baseline to 6 months and 12 months (HT Phase)
Secondary	Clinical events (e.g. death, CVD development, hospitalizations) at 6 and 12 months		Baseline to 6 months and 12 months (HT Phase)
Secondary	Country-specific process outcomes at 6 and 12 months		Baseline to 6 months and 12 months (HT Phase)
Secondary	Change in individual components of the primary outcomes in the HT Phase		Undetermined - currently not initiated and is dependent on funding (CVD Phase)
Secondary	Secondary outcomes from the HT Phase		Undetermined - currently not initiated and is dependent on funding (CVD Phase)

External Links

•   Population Health Research Institute