Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial
BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6070 (Published 17 October 2013) Cite this as: BMJ 2013;347:f6070
- Hilary Pinnock, reader1,
- Janet Hanley, principal research fellow2,
- Lucy McCloughan, programme manager3,
- Allison Todd, research nurse3,
- Ashma Krishan, statistician4,
- Stephanie Lewis, reader in medical statistics5,
- Andrew Stoddart, health economist6,
- Marjon van der Pol, professor of health economics7,
- William MacNee, professor of respiratory and environmental medicine8,
- Aziz Sheikh, professor of primary care research and development and directorHarkness fellow in healthcare policy and practice19,
- Claudia Pagliari, senior lecturer in primary care and health informatics3,
- Brian McKinstry, professor of primary care ehealth3
- 1Allergy and Respiratory Research Group, Centre for Population Health Sciences, University of Edinburgh, Edinburgh EH8 9AG, UK
- 2School of Nursing, Midwifery and Social Care, Edinburgh Napier University, Edinburgh, UK
- 3eHealth Research Group, Centre for Population Health Sciences, Edinburgh, UK
- 4Edinburgh Clinical Trials Unit, University of Edinburgh, UK
- 5Centre for Population Health Sciences, Edinburgh, UK
- 6Health Services Research Unit, University of Edinburgh, UK
- 7Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
- 8Centre for Inflammation Research, University of Edinburgh, UK
- 9Division of General Internal Medicine and Primary Care, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
- Correspondence to: H Pinnock hilary.pinnock{at}ed.ac.uk
- Accepted 3 September 2013
Abstract
Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care.
Design Researcher blind, multicentre, randomised controlled trial.
Setting UK primary care (Lothian, Scotland).
Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems.
Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services.
Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat.
Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person (standard deviation 1.9) v control 1.1 (1.6); P=0.59). Mean duration of COPD admissions over one year was also similar between groups (9.5 days per person (standard deviation 19.1) v 8.8 days (15.9); P=0.88). The intervention had no significant effect on SGRQ scores between groups (68.2 (standard deviation 16.3) v 67.3 (17.3); adjusted mean difference 1.39 (95% confidence interval −1.57 to 4.35)), or on other questionnaire outcomes.
Conclusions In participants with a history of admission for exacerbations of COPD, telemonitoring was not effective in postponing admissions and did not improve quality of life. The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication.
Trial registration ISRCTN96634935.
Funding: The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government (ARPG/07/03). The funder had no role in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. NHS Lothian supported the telemonitoring service and the clinical services.
Footnotes
We thank Lewis Ritchie, Anne-Louise Kinmonth, and Chris Griffiths for serving on the independent trial steering committee; Wisia Wedzicha and Josep Roca for their advice as collaborators; all the professionals in Lothian who provided the clinical service, especially Angela Lindsay (long term conditions and telehealthcare lead) and Clair Sparrius from the community respiratory team; Erinn Hade and Gordon Murray for providing additional statistical support; the Wellcome Trust Clinical Research Facility for providing community research nursing; the Scottish Primary Care Research Network for assistance with participant identification; the Edinburgh Clinical Trials Unit for designing the trial database and providing the randomisation service; Susan Buckingham for undertaking quality assurance checks; and Jennifer Holmes for providing administrative support.
TELESCOT programme group: Brian McKinstry, Hilary Pinnock, Janet Hanley, Stephanie Lewis, Aziz Sheikh, William MacNee, Claudia Pagliari, Christine McClusky, Jim Forrest, John McKnight, Paul Padfield, Cathie Sudlow, and Sarah Wild.
Contributors: BM initiated the idea for the study, and with HP, led the development of the protocol, securing of funding, study administration, data analysis, interpretation of results, and writing of the paper. JH, SL, ASh, WM, and CP were grant holders who contributed to development of the protocol, securing of funding, study administration, data analysis, interpretation of results, and writing of the paper. AT undertook the data collection. LM provided liaison between the research and clinical teams, and provided the regulatory oversight for the trial. SL and AK were the trial statisticians. MvdP and ASt undertook the health economic analysis. All authors had full access to all the data, and were involved in interpretation of the data. HP and BM wrote the initial draft of the paper, to which all the authors contributed. HP and BM are study guarantors.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: support from the Chief Scientist Office of the Scottish government and NHS Lothian for the submitted work; HP is supported by a primary care research career award from the Chief Scientist’s Office of the Scottish government; BM and JH are supported via NHS Lothian through the Edinburgh Health Services Research Unit; AS is supported by the Commonwealth Fund, a private independent foundation based in New York City; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Ethical approval was granted by the Lothian research ethics committee (reference 08/S1101/60), and NHS management approval was provided by NHS Lothian, Scotland.
Data sharing: No additional data available.
HP and BM are study guarantors and affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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