Condition category
Circulatory System
Date applied
05/09/2014
Date assigned
05/09/2014
Last edited
01/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In this study the aim is 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?
It is hoped that everyone taking part will improve their knowledge and understanding of managing heart failure. In addition, it is hoped that the intervention will improve partcipants' medication management and quality of life. However, this cannot be guaranteed. The information gained from this study may help to treat patients with heart failure better in the future. There are no expected harms from participating in 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?
September 2014 to September 2017

Who is funding the study?
1. National Institute for Health Research (NIHR) Oxford Biomedical Research Centre
2. National Institute for Health Research (NIHR) Career Development Fellowship

Who is the main contact?
Prof. Kazem Rahimi
kazem.rahimi@georgeinstitute.ox.ac.uk

Trial website

http://supporthf.org/

Contact information

Type

Scientific

Primary contact

Prof Kazem Rahimi

ORCID ID

http://orcid.org/0000-0002-4807-4610

Contact details

Le Gros Clark Building
University of Oxford
South Parks Road
Oxford
OX1 3QX
United Kingdom
-
kazem.rahimi@georgeinstitute.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17276

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

Acronym

SUPPORT-HF 2

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

First MREC approval date 28/08/2014, ref: 14/SS/1025

Study design

Randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

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

Condition

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

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/09/2014

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

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

01/09/2014

Recruitment end date

30/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Frimley Health NHS Foundation Trust
Camberley
GU16 7UJ
United Kingdom

Trial participating centre

Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Leicestershire Partnership NHS Trust
Leicester
LE4 8PQ
United Kingdom

Trial participating centre

Royal Devon and Exeter NHS Foundation Trust
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Central Manchester University Hospitals NHS Foundation Trust
Manchester
M13 9WL
United Kingdom

Trial participating centre

South Eastern Health and Social Care Trust
Dundonald
BT16 1RH
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials & Research Governance Research Services
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR Oxford Biomedical Research Centre (BRC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists intend to publish the baseline findings before the completion of the trial and then the final results, both in speciality cardiology journals.

IPD sharing plan
The datasets generated during and/or analysed during the current study may be available upon request from supporthf@georgeinstitute.ox.ac.uk

Intention to publish date

30/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/08/2017: Updated trial participating centres. 26/01/2017: The following changes were made to the trial record: 1. The overall trial end date was changed from 01/09/2015 to 30/09/2017. 2. The target number of participants was changed from 250 to 200. 3. NIHR Oxford Biomedical Research Centre (BRC) was added as a funder.