Condition category
Circulatory System
Date applied
04/09/2015
Date assigned
07/10/2015
Last edited
07/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
denise.fleming-brown@dph.ox.ac.uk

Trial website

http://supportcvd.com/

Contact information

Type

Public

Primary contact

Mrs Denise Fleming-Brown

ORCID ID

http://orcid.org/0000-0003-1534-9718

Contact details

The George Institute for Global Health
Nuffield Department of Population Health
University of Oxford
34 Broad Street
Oxford
OX1 3BD
United Kingdom
+44 1865 617211
denise.fleming-brown@dph.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15-15

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

Acronym

SUPPORT-CVD

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

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Cardiovascular disease

Intervention

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

Other

Phase

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

01/11/2014

Overall trial end date

30/06/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 45 years or above
2. Rural dwellers

Participant type

Mixed

Age group

Adult

Gender

Both

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

01/10/2015

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Iran

Trial participating centre

Non-Communicable Diseases Research Center
Endocrinology and Metabolism Research Institute (NCDRC) Tehran University of Medical Sciences
Tehran
1599666615
Iran

Sponsor information

Organisation

University of Oxford

Sponsor details

Medical Research Services
University of Oxford
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Iranian Ministry of Health and Medical Education

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

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

Location

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

31/12/2021

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes