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 participants 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
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
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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 measure
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 (if study stopped)
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 participants 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
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
Basic results (scientific)
Publication list