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  3. Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial
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Research

Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f653 (Published 26 February 2013) Cite this as: BMJ 2013;346:f653
  1. Martin Cartwright, research associate in health services research1,
  2. Shashivadan P Hirani, senior lecturer in health services research1,
  3. Lorna Rixon, research associate in health services research1,
  4. Michelle Beynon, research assistant in health services research1,
  5. Helen Doll, senior research associate2,
  6. Peter Bower, professor of health services research6,
  7. Martin Bardsley, head of research3,
  8. Adam Steventon, senior research analyst3,
  9. Martin Knapp, professor of social policy 4,
  10. Catherine Henderson, research officer4,
  11. Anne Rogers, professor of health systems implementation5,
  12. Caroline Sanders, lecturer in medical sociology6,
  13. Ray Fitzpatrick, professor of public health and primary care7,
  14. James Barlow, professor of technology and innovation management (healthcare)8,
  15. Stanton P Newman, principal investigator, professor, dean1
  16. for the Whole Systems Demonstrator evaluation team
  1. 1School of Health Sciences, City University London, London EC1A 7QN, UK
  2. 2University of East Anglia, Norwich, UK
  3. 3The Nuffield Trust, London, UK
  4. 4London School of Economics and Political Science, London, UK
  5. 5University of Southampton, Southampton, UK
  6. 6University of Manchester, Manchester, UK
  7. 7University of Oxford, Oxford, UK
  8. 8Imperial College Business School, London, UK
  1. Correspondence to: S P Newman stanton.newman.1{at}city.ac.uk
  • Accepted 16 January 2013

Abstract

Objective To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions.

Design A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care. Data were collected at baseline, four months (short term), and 12 months (long term). Primary intention to treat analyses tested treatment effectiveness; multilevel models controlled for clustering by general practice and a range of covariates. Analyses were conducted for 759 participants who completed questionnaire measures at all three time points (complete case cohort) and 1201 who completed the baseline assessment plus at least one other assessment (available case cohort). Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts, respectively.

Setting Provision of primary and secondary care via general practices, specialist nurses, and hospital clinics in three diverse regions of England (Cornwall, Kent, and Newham), with established integrated health and social care systems.

Participants Patients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009.

Main outcome measures Generic, health related quality of life (assessed by physical and mental health component scores of the SF-12, and the EQ-5D), anxiety (assessed by the six item Brief State-Trait Anxiety Inventory), and depressive symptoms (assessed by the 10 item Centre for Epidemiological Studies Depression Scale).

Results In the intention to treat analyses, differences between treatment groups were small and non-significant for all outcomes in the complete case (0.480≤P≤0.904) or available case (0.181≤P≤0.905) cohorts. The magnitude of differences between trial arms did not reach the trial defined, minimal clinically important difference (0.3 standardised mean difference) for any outcome in either cohort at four or 12 months. Per protocol analyses replicated the primary analyses; the main effect of trial arm (telehealth v usual care) was non-significant for any outcome (complete case cohort 0.273≤P≤0.761; available case cohort 0.145≤P≤0.696).

Conclusions Second generation, home based telehealth as implemented in the Whole Systems Demonstrator Evaluation was not effective or efficacious compared with usual care only. Telehealth did not improve quality of life or psychological outcomes for patients with chronic obstructive pulmonary disease, diabetes, or heart failure over 12 months. The findings suggest that concerns about potentially deleterious effect of telehealth are unfounded for most patients.

Trial Registration ISRCTN43002091.

Footnotes

  • We thank Alan Glanz (Department of Health) and Chris Ham (The King’s Fund) for their support throughout the study; all the individual participants for their time and interest in the study; and all the managers and professionals in Cornwall, Kent, and Newham in the health and social services and in the participating case study organisations for their help.

  • Whole System Demonstrator evaluation team members: Stanton P Newman (principal investigator), Martin Bardsley (The Nuffield Trust), James Barlow (Imperial College London), Jennifer Beecham (London School of Economics), Michelle Beynon (City University London/University College London), John Billings (The Nuffield Trust), Andy Bowen (University of Manchester), Pete Bower (University of Manchester), Martin Cartwright (City University London/University College London), Theopisti Chrysanthaki (Imperial College London), Jennifer Dixon (The Nuffield Trust), Helen Doll (University of East Anglia), Jose-Luis Fernandez (London School of Economics), Ray Fitzpatrick (Oxford University), Catherine Henderson (London School of Economics), Jane Hendy (Imperial College London), Shashivadan P Hirani (City University London/University College London), Martin Knapp (London School of Economics), Virginia MacNeill (Oxford University), Lorna Rixon (City University London/University College London), Anne Rogers (University of Southampton), Caroline Sanders (University of Manchester), Luis A Silva (City University London/University College London), Adam Steventon (The Nuffield Trust).

  • Contributors: MC and SPH are joint first authors. MC, SH, LR, and MBe conducted preliminary analyses under HD’s supervision. MC conducted the final analyses and drafted the manuscript. HD, PB, MBa, MK, CH, AR, CS, RF, JB, SH, and SN contributed to development of the overall WSD study protocol. SN is the principal investigator for the WSD Evaluation. HD is the trial statistician and guarantor of statistical quality for the WSD Evaluation. MC, SH, LR, MBe, and SN contributed to the planning of the questionnaire data collection; MC, SH, LR, and MBe coordinated the daily implementation of the questionnaire assessment protocol and maintained trial data. HD, SH, MC, LR, MBe, AS, and CH contributed to planning of the analyses. All the authors reviewed the manuscript. The evaluation team met regularly during the trial period, reviewed interim documents and preliminary analyses, and contributed as a whole to discussions of the analytical strategy.

  • Funding: This is an independent report commissioned and funded by the Policy Research Programme in the UK Department of Health.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the Department of Health and the University College London Hospitals and University College London; several authors have undertaken evaluative work funded by government or public agencies but these have not created competing interests; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: The study was approved by Liverpool research ethics committee (ref 08/H1005/4).

  • Data sharing: No additional data available.

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