Objectives We aimed to investigate whether digital home monitoring with centralised specialist support for remote management of heart failure (HF) is more effective in improving medical therapy and patients’ quality of life than digital home monitoring alone.
Methods In a two-armed partially blinded parallel randomised controlled trial, seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years SD 11.1; left ventricular ejection fraction 32.9% SD 15.4). Participants in both study arms were given a tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring. Participants randomised to intervention received additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment. The primary outcome was the use of guideline-recommended medical therapy for chronic HF and major comorbidities, measured as a composite opportunity score (total number of recommended treatment given divided by the total number of opportunities the treatment should have been given, with a score 1 indicating 100% adherence to recommendations). Co-primary outcome was change in physical score of Minnesota Living with Heart Failure questionnaire.
Results 101 patients were randomised to ‘enhanced self-management’ and 101 to ‘supported medical management’. At the end of follow-up, the opportunity score was 0.54 (95% CI 0.46 to 0.62) in the control arm and 0.61 (95% CI 0.52 to 0.70) in the intervention arm (p=0.25). Physical well-being of participants also did not differ significantly between the groups (17.4 (12.4) mean (SD) for control arm vs 16.5 (12.1) in treatment arm; p for change=0.84).
Conclusions Central provision of tailored specialist management in a multi-morbid HF population was feasible. However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
Trial registration number ISRCTN86212709
- heart failure
- quality and outcomes of care
- health care delivery
- eHealth/telemedicine/mobile health
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Twitter @kazemr, @MiladNazarzadeh
Collaborators Investigators: Kazem Rahimi (Chief Investigator, George Institute for Global Health, University of Oxford, Oxford), Sudip Ghosh, Lynne Hartwell (Leicestershire Partnership NHS Trust, Leicester), Andrew Ludman, Lisa Adams, Clare Hardman, Anna Hunt, Sam Keenan (Royal Devon and Exeter NHS Foundation Trust, Exeter), Patrick Donnelly, Stephanie Kelly, Susan Regan, Dawn Turnbull (South Eastern Health and Social Care Trust, Belfast), Fozia Ahmed, Hannah Phillips (Central Manchester University Hospitals NHS Foundation Trust, Manchester), Attila Kardos, Lynn Wren (Milton Keynes University Hospital NHS Foundation Trust, Milton Keynes), Jeremy Dwight, Rebecca Bone, Helen Jackson, Helen Nolte, Kirstine Warhurst (Oxford University Hospitals NHS Foundation Trust, Oxford), Constantinos Missouris, Stephanie Murray, Mark Stephens (Frimley Health NHS Foundation Trust, Camberley). Trial Steering Committee: Kazem Rahimi, Mark Woodward, Reza Khorshidi (George Institute for Global Health, University of Oxford, Oxford), Raymond Fitzpatrick (Nuffield Department of Population Health, University of Oxford, Oxford), Lionel Tarassenko (Institute of Biomedical Engineering, University of Oxford, Oxford), Mike Denis (Oxford Academic Health Science Network, Oxford), John Cleland (National Heart and Lung Institute, Imperial College, London). IT and Engineering Committee: Abel Perez, Cristian Fernandez, Manuel Martin, Hamid Mohseni, Raquel Rodriguez (George Institute for Global Health, University of Oxford, Oxford), Carmelo Velardo, Johanna Ernst, Andreas Triantafyllidis, Johanna O’Donnell, Lionel Tarassenko (Institute of Biomedical Engineering, University of Oxford, Oxford). Trial Management Committee: Moira Allison, Nathalie Conrad, Denise Fleming-Brown, Deborah Hedgecott, Abel Perez, Deborah Cross (George Institute for Global Health, University of Oxford, Oxford). Statistical analysis: Milad Nazarzadeh, Mark Woodward (The George Institute for Global Health, University of Oxford, Oxford), Toshiaki Ohkuma (The George Institute for Global Health, UNSW Sydney, Australia).
Contributors KR is the guarantor. KR, MW, GS-K, RF, LT, MD, JGC: planning, conduct and reporting. MN: statistical analysis and drafting. ACP-G: drafting and editing. TO: statistical analysis. The details of SUPPORT-HF 2 committees and investigators are described below.
Funding This work was supported by the National Institute for Health Research (NIHR) Health Services Research and Delivery (grant no. 13/114/102), NIHR Career Development Fellowship (grant no. CDF-2013-06-012), British Heart Foundation (grant no. PG/18/65/33872), as well as the NIHR Oxford Biomedical Research Centre and the Oxford Martin School.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Ethics approval Ethics approval was obtained from the medical research and ethics committee (approval date 28/08/2014, reference 14/SS/1025).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data (deidentified participant data) are available on reasonable request from the corresponding author.
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