Home monitoring with integrated risk-stratified disease management support versus home monitoring alone in patients with heart failure
| ISRCTN | ISRCTN86212709 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86212709 |
| Secondary identifying numbers | 17276 |
- Submission date
- 05/09/2014
- Registration date
- 05/09/2014
- Last edited
- 16/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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@wrh.ox.ac.uk
Contact information
Scientific
Hayes House
University of Oxford
75 George Street
Oxford
OX1 2BQ
United Kingdom
 ORCID ID |
0000-0002-4807-4610 |
|---|---|
| kazem.rahimi@wrh.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Home monitoring with integrated risk-stratified disease management support versus home monitoring alone in patients with heart failure: a randomised controlled trial |
| Study acronym | SUPPORT-HF 2 |
| Study objectives | 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(s) | First MREC approval date 28/08/2014, ref: 14/SS/1025 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2014 |
| Completion date | 30/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 200; UK Sample Size: 200 |
| Total final enrolment | 202 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2014 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- England
- Northern Ireland
- United Kingdom
Study participating centres
OX3 9DU
United Kingdom
GU16 7UJ
United Kingdom
MK6 5LD
United Kingdom
LE4 8PQ
United Kingdom
EX2 5DW
United Kingdom
M13 9WL
United Kingdom
BT16 1RH
United Kingdom
Sponsor information
University/education
Clinical Trials & Research Governance Research Services
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 31/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | design and baseline results | 01/02/2019 | Yes | No | |
| Results article | results | 01/10/2020 | 08/07/2020 | Yes | No |
| Other publications | report | 27/10/2020 | 29/10/2020 | Yes | No |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
16/06/2021: The scientific contact has been updated and the plain English summary has been updated accordingly.
29/10/2020: Publication reference added.
08/07/2020: Publication reference added.
30/10/2019: The intention to publish date was changed from 31/10/2019 to 31/01/2020.
25/04/2019: The following changes were made to the trial record:
1. Publication reference and total final enrolment added.
2. The intention to publish date was changed from 30/09/2018 to 31/10/2019.
3. Contact details updated.
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.
