Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In this study we aim to test whether a mobile health home monitoring system, which is linked to patients’ health records and able to provide specialist alert and advice to patients and predictive clinical decision support tools to healthcare practitioners, can improve heart failure patients’ management.

Who can participate?
Adult men and women diagnosed with heart failure.

What does the study involve?
Participants are randomly allocated to either receive personalised feedback on their health or not. Participants are given and taught how to use a tablet PC to answer a short series of questions about their health and wellbeing and record their blood pressure, weight and heart rate. They are asked to complete these questions and measurements on a daily or regular basis for a period of about 6 months. Some participants may also be asked to carry a small monitor (FitBit) to record information about their level of physical activity and sleeping pattern. All of this data is captured and stored securely on the tablet PC and then wirelessly transferred in real-time to secure central servers at the University of Oxford where it is reviewed by researchers. Depending on treatment allocation and participant’s health monitoring data, they may receive more or less intensive feedback to support themselves in managing their condition better at home.

What are the possible benefits and risks of participating?
We hope that everyone taking part will improve their knowledge and understanding of managing heart failure. In addition, we hope that the intervention will improve partcipants' medication management and quality of life. However, we cannot guarantee this. The information we gain from this study may help us to treat patients with heart failure better in the future. There are no expected harms from participating into this study.

Where is the study run from?
The study is run from the participants’ homes.

When is the study starting and how long is it expected to run for?
The study starts in September 2014 and will run for a year.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Dr Kazem Rahimi

Trial website

Contact information



Primary contact

Dr Kazem Rahimi


Contact details

Old Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Home monitoring with integrated risk-stratified disease management support versus home monitoring alone in patients with heart failure: a randomised controlled trial


SUPPORT-HF 2 study, v1.0

Study hypothesis

In patients with heart failure, home monitoring coupled with an integrated data analysis and risk prediction service, providing real-time alerts and advice to patients and predictive clinical decision support tools to healthcare practitioners, is more effective in optimising medical therapy than home monitoring with the same monitoring equipment but without the use of the integrated data analysis and decision support service and the tailored self-management tools.

Ethics approval

14/SS/1025; First MREC approval date 28/08/2014

Study design

Randomised; Interventional; Design type: Prevention

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Heart Failure


Intervention: Collection of symptoms, physiological and system usage information from commercially available home monitoring devices and their integration with electronic health records (EHRs) for estimation of fluid status and risk. Risk-based algorithmic management supported by a specialist medical team and computer algorithms.

Control: Collection of symptoms, physiological and system usage information from commercially available home monitoring devices, as well as biochemical data from EHRs, but the data collected will not processed to provide personalised feedback to patients for self-management or to their doctors for risk-based monitoring or drug management. Participants’ pharmacological care will not be supported by the system.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Optimal medical therapy: Optimal medical therapy is defined as treatment consistent with the NICE guidelines for management of patients with chronic heart failure and will be measured as a composite opportunity score.

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the trial
2. Male or female, aged 18 years or above
3. Diagnosed with heart failure, defined as presence of typical symptoms (e.g. breathlessness, ankle swelling, and fatigue) and signs (e.g. elevated jugular venous pressure, pulmonary crackles, and displaced apex beat) resulting from an abnormality of cardiac structure or function
4. Potential to benefit from home monitoring and management defined as:
4.1. Self-assessed NYHA class II to IV; or
4.2. BNP >100 pg/L or NT-pro-BNP >360 pg/L in the last 30 days (excluding in-hospital measures)
AND either
4.3. Not on optimal therapy (in view of the Investigator), or
4.4. Probability of death within one year >10% (MAGGIC integer score 20 or more)
4.5. At least one hospital admission related to heart failure in the previous 12 months

Participant type


Age group




Target number of participants

Planned Sample Size: 250; UK Sample Size: 250

Participant exclusion criteria

1. No reliable 3G mobile or Wi-Fi network connectivity at home
2. Unable to read or speak English
3. Any other significant disease, including critical unstable or end-stage heart failure, which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Old Road , Headington
United Kingdom

Sponsor information


University of Oxford (UK)

Sponsor details

Wellcome Trust Centre for Human Genetics
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Career Development Fellowship (UK); Grant Codes: CDF-2013-06-012

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes