Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Health workers in the community play an important part in providing healthcare to people in rural areas. In 1979, Iran introduced a new heath system to help disadvantaged groups receive adequate healthcare. Trained community health workers known as “Behvarzes” typically work in rural health centres in pairs or threes, and provide basic healthcare and support to people in rural and disadvantaged areas. In recent years, the Behvarzes have taken part in screening for diseases that could cause serious cardiovascular problems (heart attacks and strokes), such as diabetes or high blood pressure (hypertension). At present however, they are not well enough equipped to take preventative action against these conditions and so many patients have to seek help from doctors. A new system (SUPPORT-CVD) has been developed which uses a touch-screen computer tablet to provide cardiovascular healthcare information, as well as supporting communication between the Behavarze and doctors. The aim of this study is to find out whether the SUPPORT-CVD technology can help to better prevent and manage heart and circulatory problems among in rural communities.

Who can participate?
Adults over 45 years of age, who live in rural areas of Iran and attend the participating rural health centres.

What does the study involve?
Participating health centres are randomly allocated to one of two groups. Patients attending health centres in the first group (control group) are treated by Behvarzes who have been trained to use the PC tablet. The tablet provides the Behvarzes with the means to test patients to see if they are at risk of cardiovascular problems. The tablet then provides them with limited information about the health of patients over the next 6 months (follow up period). Patients in the second group are treated by Behvarzes who are trained to use the tablet but they are also able to treat patients, by providing medications to the patients who are at risk of heart disease or stroke. For the 6 month follow up period, the Behvarzes are able to access more complete information about their patients’ health. At the end of the follow up period, the amount of patients who have suffered from heart attacks and strokes is recorded for both groups.

What are the possible benefits and risks of participating?
Benefits of participating include the possibility of improving the way that heart disease is managed in rural areas. There are no notable risks of participating in this study.

Where is the study run from?
310 rural health centres in Iran.

When is the study starting and how long is it expected to run for?
November 2014 to June 2020

Who is funding the study?
1. Medical Research Council (UK)
2. Wellcome Trust (UK)
3. Department for International Development (UK)
4. Iranian Ministry of Health and Medical Education (Iran)

Who is the main contact?
Mrs Denise Fleming-Brown

Trial website

Contact information



Primary contact

Mrs Denise Fleming-Brown


Contact details

The George Institute for Global Health
Nuffield Department of Population Health
University of Oxford
34 Broad Street
United Kingdom
+44 1865 617211

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A study using advanced technologies to support Behvarzes in risk screening and management of serious heart and circulatory problems in people living in rural areas of Iran



Study hypothesis

A low-cost technology-assisted and community-based programme of evidence-based CVD management will reduce the risk of serious cardiovascular events by at least 20% in high-risk individuals.

Ethics approval

Oxford Tropical Research Ethics Committee (OxTREC), 23/06/2015, ref: 15-15

Study design

Multi-centre two-armed partially blinded cluster randomised trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet


Cardiovascular disease


The core of the complex intervention is a medical device (software) that provides decision support to non-physical healthcare workers. To reduce treatment contamination between intervention and control participants and to avoid selection bias, a concealed and computer-generated cluster randomized trial is used in this study in which rural health centres and one of their affiliated health houses are used as the unit of randomization and not the trial participant. Participants will only be enrolled and asked for their consent after cluster randomization. Randomization will be performed by the statistical team at the NCDRC.

Control Clusters: Non-physician healthcare workers will be trained in use of a tablet PC application and point-of-care diagnostics for measurement of cardiovascular risk factors and collection of limited information about participants’ health status during follow-up.

Intervention Clusters: Point-of-care diagnostics and a tablet PC application will be used to empower non-physician healthcare workers in risk measurement and communication with patients, drug prescription (including the use of four different types of polypill), and adherence management. The intervention includes continuous training and performance management of healthcare workers.

Follow-ups for both control and interventional clusters are every 6 months. In the intervention clusters, additional appointments will be booked for patients with abnormal clinical findings or those prescribed drugs to ensure tolerability, adherence and treatment modification.

Intervention type



Drug names

Primary outcome measures

1. Rate of major cardiac events (non-fatal myocardial infarction or cardiac death) determined at the end of the study period
2. Rate of stroke (fatal and non-fatal) determined at the end of the study period

Secondary outcome measures

Total number of vascular events are measured at the end of the study. These are defined as cardiovascular death, myocardial infarction, stroke, heart failure death or hospitalisation, end-stage renal disease (chronic renal dialysis, renal transplant, death from renal disease), and cardiovascular (CV) hospitalizations for atrial fibrillation or angina, or arterial revascularization.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged 45 years or above
2. Rural dwellers

Participant type


Age group




Target number of participants

55,000 participants of which 30,000 will be high-risk participants

Participant exclusion criteria

Any reason that may either put the participant at risk because of participation in the trial, or the participant’s ability to participate in the trial (e.g. dementia or end-stage cancer).

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Non-Communicable Diseases Research Center
Endocrinology and Metabolism Research Institute (NCDRC) Tehran University of Medical Sciences

Sponsor information


University of Oxford

Sponsor details

Medical Research Services
University of Oxford
Joint Research Office
Block 60
Churchill Hospital
Old Road
United Kingdom

Sponsor type




Funder type


Funder name

Iranian Ministry of Health and Medical Education

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Medical Research Council

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Funder name

Department for International Development

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

The Trial Management Group will aim to publish the trial findings in an open access journal.

Intention to publish date


Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes