Self-Management Support Using a Digital Health System Compared With Usual Care for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial

Journal of Medical Internet Research

Volumn 19, Issue 5, 2017, Pages

  Farmer, Andrew ^a   Williams, Veronika ^a   Velardo, Carmelo ^b   Shah, Syed Ahmar ^b   Yu, Ly Mee ^a   Rutter, Heather ^a   Jones, Louise ^a   Williams, Nicola ^a   Heneghan, Carl ^a   Price, Jonathan ^a   Hardinge, Maxine ^c   Tarassenko, Lionel ^b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

Chronic obstructive; Pulmonary disease; Randomized controlled trial; Self care; Telehealth

Indexed keywords

AGED; COMPARATIVE STUDY; CONTROLLED STUDY; FEMALE; HEALTH STATUS; HUMAN; MALE; PROCEDURES; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SELF CARE;

AGED; FEMALE; HEALTH STATUS; HUMANS; MALE; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUALITY OF LIFE; SELF CARE; SURVEYS AND QUESTIONNAIRES;

EID: 85019837772     PISSN: None     EISSN: 14388871     Source Type: Journal    
DOI: 10.2196/jmir.7116     Document Type: Article

References (52)

1. World Health Organization. The global burden of disease update. In: The Global Burden of Disease: 2004 Update. Geneva: World Health Organization; 2004:1-133.
2. National Clinical Guideline Centre. Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care. London: NICE; 2010.
3. Okubadejo AA, O'Shea L, Jones P. Home assessment of activities of daily living in patients with severe chronic obstructive pulmonary disease on long-Term oxygen therapy. Eur Respir J 1997;10:1572-1575. [doi:10.1183/09031936.97.10071572].
4. Ståhl E, Lindberg A, Jansson S, Rönmark E, Svensson K, Andersson F, et al. Health-related quality of life is related to COPD disease severity. Health Qual Life Outcomes 2005 Sep 09;3:56 [FREE Full text] [doi:10.1186/1477-7525-3-56] [Medline: 16153294].
5. Wedzicha JA, Seemungal T. COPD exacerbations: defining their cause and prevention. The Lancet 2007;370:786-796.
6. Wilkinson TMA, Donaldson GC, Hurst JR, Seemungal TAR, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004 Jun 15;169(12):1298-1303. [doi:10.1164/rccm.200310-1443OC] [Medline: 14990395].
7. Seymour JM, Moore L, Jolley CJ, Ward K, Creasey J, Steier JS, et al. Outpatient pulmonary rehabilitation following acute exacerbations of COPD. Thorax 2010 May;65(5):423-428. [doi:10.1136/thx.2009.124164] [Medline: 20435864].
8. Bourbeau J, Julien M, Maltais F. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: A disease-specific self-management intervention. Arch Intern Med 2003;163:585-591.
9. Rea H, McAuley S, Stewart A, Lamont C, Roseman P, Didsbury P. A chronic disease management programme can reduce days in hospital for patients with chronic obstructive pulmonary disease. Intern Med J 2004 Nov;34(11):608-614. [doi:10.1111/j.1445-5994.2004.00672.x] [Medline: 15546454].
10. Effing T, Monninkhof EM, van der Valk PD, van der Palen J, van Herwaarden CL, Partidge MR, et al. Self-management education for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007 Oct 17(4):CD002990. [doi:10.1002/14651858.CD002990.pub2] [Medline: 17943778].
11. Baraniak A, Sheffield D. The efficacy of psychologically based interventions to improve anxiety, depression and quality of life in COPD: A systematic review and meta-Analysis. Patient Educ Couns 2011 Apr;83(1):29-36. [doi:10.1016/j.pec.2010.04.010] [Medline: 20447795].
12. Bischoff EW, Hamd DH, Sedeno M. Effects of written action plan adherence on COPD exacerbation recovery. Thorax 2011;66:26-31. [doi:10.1136/thx.2009.127621].
13. Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, et al. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: A randomized, controlled trial. Ann Intern Med 2012 May 15;156(10):673-683. [doi:10.7326/0003-4819-156-10-201205150-00003] [Medline: 22586006].
14. Whitehead L, Seaton P. The effectiveness of self-management mobile phone and tablet apps in long-Term condition management: A systematic review. J Med Internet Res 2016 May;18(5):e97 [FREE Full text] [doi:10.2196/jmir.4883] [Medline: 27185295].
15. Lundell S, Holmner Å, Rehn B, Nyberg A, Wadell K. Telehealthcare in COPD: A systematic review and meta-Analysis on physical outcomes and dyspnea. Respir Med 2015 Jan;109(1):11-26 [FREE Full text] [doi:10.1016/j.rmed.2014.10.008] [Medline: 25464906].
16. McLean S, Nurmatov U, Liu JLY, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease: Cochrane Review and meta-Analysis. Br J Gen Pract 2012 Nov;62(604):739-749 [FREE Full text] [doi:10.3399/bjgp12X658269] [Medline: 23211177].
17. Aaron SD, Donaldson G, Whitmore G. Time course and pattern of COPD exacerbation onset. Thorax 2011;67:238-243.
18. Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, et al. Home telehealth for chronic obstructive pulmonary disease: A systematic review and meta-Analysis. J Telemed Telecare 2010;16(3):120-127. [doi:10.1258/jtt.2009.090812] [Medline: 20197355].
19. Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, et al. Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. BMJ 2012 Jun 21;344:e3874. [doi:10.1136/bmj.e3874].
20. Fairbrother P, Pinnock H, Hanley J, McCloughan L, Sheikh A, Pagliari C, et al. Continuity, but at what cost? the impact of telemonitoring COPD on continuities of care: A qualitative study. Prim Care Respir J 2012 Sep;21(3):322-328 [FREE Full text] [doi:10.4104/pcrj.2012.00068] [Medline: 22875143].
21. Takahashi PY, Pecina JL, Upatising B, Chaudhry R, Shah ND, Van HH, et al. A randomized controlled trial of telemonitoring in older adults with multiple health issues to prevent hospitalizations and emergency department visits. Arch Intern Med 2012 May 28;172(10):773-779 [FREE Full text] [doi:10.1001/archinternmed.2012.256] [Medline: 22507696].
22. Pinnock H, Hanley J, McCloughan L, Todd A, Krishan A, Lewis S, et al. 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 Oct 17;347:6070. [doi:10.1136/bmj.f6070].
23. Williams V, Price J, Hardinge M, Tarassenko L, Farmer A. Using a mobile health application to support self-management in COPD: A qualitative study. Br J Gen Pract 2014 Jul;64(624):e392-e400 [FREE Full text] [doi:10.3399/bjgp14X680473] [Medline: 24982491].
24. Shah SA, Velardo C, Gibson OJ, Rutter H, Farmer A, Tarassenko L. Personalized alerts for patients with COPD using pulse oximetry and symptom scores. In: Conf Proc IEEE Eng Med Biol Soc. 2014 Presented at: Conf Proc IEEE Eng Med Biol Soc; 2014; Chicago p. 3164-3167 URL: http://ieeexplore.ieee.org/document/6944294/[doi:10.1109/EMBC.2014.6944294].
25. Hardinge M, Rutter H, Velardo C. Using a mobile health application to support self-management in COPD-development of alert thresholds derived from variability in self-reported and measured clinical variables. Am J Respir Crit Care Med 2014;189:A1396.
26. Greenhalgh T, Procter R, Wherton J, Sugarhood P, Shaw S. The organising vision for telehealth and telecare: discourse analysis. BMJ Open 2012 Jul;2(4):e001574 [FREE Full text] [doi:10.1136/bmjopen-2012-001574] [Medline: 22815469].
27. Hardinge M, Rutter H, Velardo C, Shah SA, Williams V, Tarassenko L, et al. Using a mobile health application to support self-management in chronic obstructive pulmonary disease: A six-month cohort study. BMC Med Inform Decis Mak 2015 Jun 18;15:1-10 [FREE Full text] [doi:10.1186/s12911-015-0171-5] [Medline: 26084626].
28. Farmer A, Toms C, Hardinge M, Williams V, Rutter H, Tarassenko L. Self-management support using an internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial. BMJ Open 2014 Jan;4(1):e004437 [FREE Full text] [doi:10.1136/bmjopen-2013-004437] [Medline: 24401729].
29. Dumville JC, Hahn S, Miles JNV, Torgerson DJ. The use of unequal randomisation ratios in clinical trials: A review. Contemp Clin Trials 2006 Feb;27(1):1-12. [doi:10.1016/j.cct.2005.08.003] [Medline: 16236557].
30. Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandström T, Taylor AF, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): A randomised, double-blind, parallel-group study. Lancet Respir Med 2013 May;1(3):199-209. [doi:10.1016/S2213-2600(13)70052-3].
31. Bucknall CE, Miller G, Lloyd SM, Cleland J, McCluskey S, Cotton M, et al. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: Randomised controlled trial. BMJ 2012 Mar 06;344(1):e1060. [doi:10.1136/bmj.e1060].
32. Löwe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, et al. A 4-item measure of depression and anxiety: validation and standardization of the patient health questionnaire-4 (PHQ-4) in the general population. J Affect Disord 2010 Apr;122:86-95. [doi:10.1016/j.jad.2009.06.019] [Medline: 19616305].
33. Kroenke K, Strine TW, Spitzer RL, Williams JBW, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord 2009 Apr;114:163-173. [doi:10.1016/j.jad.2008.06.026] [Medline: 18752852].
34. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: The GAD-7. Arch Intern Med 2006 May 22;166(10):1092-1097. [doi:10.1001/archinte.166.10.1092] [Medline: 16717171].
35. McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2015:CD003793. [doi:10.1002/14651858.CD003793.pub3/full].
36. Hey SP, Kimmelman J. The risk-escalation model: A principled design strategy for early-phase trials. Kennedy Inst Ethics J 2014;24:121-139.
37. Meguro M, Barley EA, Spencer S, Jones PW. Development and validation of an improved, COPD-specific version of the St. George respiratory questionnaire. Chest 2007 Aug;132(2):456-463. [doi:10.1378/chest.06-0702] [Medline: 17646240].
38. Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health 1999 Jan;14(1):1-24. [doi:10.1080/08870449908407311].
39. Derogatis LRL, Lipman R, Covi L. SCL-90: An outpatient psychiatric rating scale-preliminary report. Psychopharmacol Bull 1973;9:13-28.
40. Derogatis LR, Lipman R, Rickels K. The Hopkins Symptom Checklist (HSCL): A self-report symptom inventory. Behavioral Science 1974;19:1-15.
41. EuroQol Group. Euro Qol: A new facility for the measurement of health related quality of life. Health Pol 2001;16:199-208.
42. Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2009 Oct 15;180(8):741-750. [doi:10.1164/rccm.200904-0492OC] [Medline: 19644045].
43. McLean S, Nurmatov U, Liu JL, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2011(7):CD007718. [doi:10.1002/14651858.CD007718.pub2] [Medline: 21735417].
44. Curtis L, Burns A. Unit Costs of Health & Social Care 2016. Canterbury, UK: PSSRU; 2016.
45. Velardo C, Shah SA, Gibson O, Clifford G, Heneghan C, Rutter H, et al. Digital health system for personalised COPD long-Term management. BMC Med Inform Decis Mak 2017 Feb 20;17(1):1-13 [FREE Full text] [doi:10.1186/s12911-017-0414-8] [Medline: 28219430].
46. Goldstein RS, O'Hoski S. Telemedicine in COPD: Time to pause. Chest 2014 May;145(5):945-949. [doi:10.1378/chest.13-1656] [Medline: 24798834].
47. Steventon A, Bardsley M, Doll H, Tuckey E, Newman SP. Effect of telehealth on glycaemic control: Analysis of patients with type 2 diabetes in the whole systems demonstrator cluster randomised trial. BMC Health Serv Res 2014 Aug 06;14:1-12 [FREE Full text] [doi:10.1186/1472-6963-14-334] [Medline: 25100190].
48. Schou L, Ostergaard B, Rydahl-Hansen S, Rasmussen LS, Emme C, Jakobsen AS, et al. A randomised trial of telemedicine-based treatment versus conventional hospitalisation in patients with severe COPD and exacerbation - effect on self-reported outcome. J Telemed Telecare 2013 Apr 23;19:160-165. [doi:10.1177/1357633X13483255] [Medline: 23612519].
49. Gregersen TL, Green A, Frausing E, Ringbæk T, Brøndum E, Suppli UC. Do telemedical interventions improve quality of life in patients with COPD? a systematic review. Int J Chron Obstruct Pulmon Dis 2016 Apr;11:809-822 [FREE Full text] [doi:10.2147/COPD.S96079] [Medline: 27143872].
50. Zwerink M, Brusse-Keizer M, van der Valk PD, Zielhuis GA, Monninkhof EM, van der Palen J, et al. Self management for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2014 Mar 19(3):CD002990. [doi:10.1002/14651858.CD002990.pub3] [Medline: 24665053].
51. Shah SA, Velardo C, Farmer A, Tarassenko L. Exacerbations in chronic obstructive pulmonary disease: identification and prediction using a digital health system. J Med Internet Res 2017 Mar 07;19(3):e69 [FREE Full text] [doi:10.2196/jmir.7207] [Medline: 28270380].
52. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al. Designing and evaluating complex interventions to improve health care. BMJ 2007 Mar 03;334(7591):455-459 [FREE Full text] [doi:10.1136/bmj.39108.379965.BE] [Medline: 17332585].