Technology-Enabled Self-Management of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Randomized Controlled Trial

Vess Stamenova, Kyle Liang, Rebecca Yang, Katrina Engel, Florence van Lieshout, Elizabeth Lalingo, Angelica Cheung, Adam Erwood, Maria Radina, Allen Greenwald, Payal Agarwal, Aman Sidhu, R Sacha Bhatia, James Shaw, Roshan Shafai, Onil Bhattacharyya, Vess Stamenova, Kyle Liang, Rebecca Yang, Katrina Engel, Florence van Lieshout, Elizabeth Lalingo, Angelica Cheung, Adam Erwood, Maria Radina, Allen Greenwald, Payal Agarwal, Aman Sidhu, R Sacha Bhatia, James Shaw, Roshan Shafai, Onil Bhattacharyya

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and leads to frequent hospital admissions and emergency department (ED) visits. COPD exacerbations are an important patient outcome, and reducing their frequency would result in significant cost savings. Remote monitoring and self-monitoring could both help patients manage their symptoms and reduce the frequency of exacerbations, but they have different resource implications and have not been directly compared.

Objective: This study aims to compare the effectiveness of implementing a technology-enabled self-monitoring program versus a technology-enabled remote monitoring program in patients with COPD compared with a standard care group.

Methods: We conducted a 3-arm randomized controlled trial evaluating the effectiveness of a remote monitoring and a self-monitoring program relative to standard care. Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program. Patients in both interventions used a Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms, but only patients in the remote monitoring group were monitored by a respiratory therapist. All patients were assessed at baseline and at 3 and 6 months after program initiation. Outcomes included self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ). Patients were also asked to self-report on health system use, and data on health use were collected from the hospital.

Results: A total of 122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups. Although all 3 groups improved in PIH scores, BCKQ scores, and SGRQ impact scores, there were no significant differences among any of the groups. No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.

Conclusions: Despite regular use of the technology, patients with COPD assigned to remote monitoring or self-monitoring did not have any improvement in patient outcomes such as self-management skills, knowledge, or symptoms, or in health care use compared with each other or with a standard care group. This may be owing to low health care use at baseline, the lack of structured educational components in the intervention groups, and the lack of integration of the action plan with the technology.

Trial registration: ClinicalTrials.gov NCT03741855; https://ichgcp.net/clinical-trials-registry/NCT03741855" title="See in ClinicalTrials.gov">NCT03741855.

Keywords: COPD; eHealth; remote consultation; self-care; telemedicine.

Conflict of interest statement

Conflicts of Interest: None declared.

©Vess Stamenova, Kyle Liang, Rebecca Yang, Katrina Engel, Florence van Lieshout, Elizabeth Lalingo, Angelica Cheung, Adam Erwood, Maria Radina, Allen Greenwald, Payal Agarwal, Aman Sidhu, R Sacha Bhatia, James Shaw, Roshan Shafai, Onil Bhattacharyya. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 30.07.2020.

Figures

Figure 1
Figure 1
Patient flow through the study. Patient flow through each arm of the study. A total of approximately 800 patients were screened for eligibility in order to obtain the final sample of 122 participants.
Figure 2
Figure 2
PIH at baseline and 3 months and baseline and 6 months for each group. Significant improvement in PIH scores from baseline to 3 months (P=.001) and from baseline to 6 months (P=.008) were observed, but no group effects or interactions, suggesting no differential effect among the groups. PIH: Partners in Health; RM: remote monitoring SC: standard care; SM: self-monitoring.

References

    1. Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent ehealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112–8. doi: 10.1016/j.amepre.2007.01.022.
    1. Chronic Respiratory Diseases: Burden of COPD. World Health Organization. [2020-02-10].
    1. All-Cause Readmission to Acute Care and Return to the Emergency Department. CIHI: Canadian Institute for Health Information. 2012. [2018-10-18]. .
    1. MacNab M, Lee SH, McCloughan L, Hanley J, McKinstry B, Pinnock H. Oximetry-supported self-management for chronic obstructive pulmonary disease: mixed method feasibility pilot project. BMC Health Serv Res. 2015 Oct 26;15:485. doi: 10.1186/s12913-015-1135-2.
    1. Vitacca M, Paneroni M, Grossetti F, Ambrosino N. Is there any additional effect of tele-assistance on long-term care programmes in hypercapnic copd patients? A retrospective study. COPD. 2016 Oct;13(5):576–82. doi: 10.3109/15412555.2016.1147542.
    1. Sorknaes AD, Madsen H, Hallas J, Jest P, Hansen-Nord M. Nurse tele-consultations with discharged COPD patients reduce early readmissions--an interventional study. Clin Respir J. 2011 Jan;5(1):26–34. doi: 10.1111/j.1752-699X.2010.00187.x.
    1. de san Miguel K, Smith J, Lewin G. Telehealth remote monitoring for community-dwelling older adults with chronic obstructive pulmonary disease. Telemed J E Health. 2013 Sep;19(9):652–7. doi: 10.1089/tmj.2012.0244.
    1. Lilholt PH, Udsen FW, Ehlers L, Hejlesen OK. Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish 'TeleCare North' cluster-randomised trial. BMJ Open. 2017 May 9;7(5):e014587. doi: 10.1136/bmjopen-2016-014587.
    1. Tupper O, Gregersen T, Ringbaek T, Brøndum E, Frausing E, Green A, Ulrik C. Effect of tele-health care on quality of life in patients with severe COPD: a randomized clinical trial. Int J Chron Obstruct Pulmon Dis. 2018;13:2657–62. doi: 10.2147/COPD.S164121. doi: 10.2147/COPD.S164121.
    1. Farmer A, Williams V, Velardo C, Shah SA, Yu L, Rutter H, Jones L, Williams N, Heneghan C, Price J, Hardinge M, Tarassenko L. Self-management support using a digital health system compared with usual care for chronic obstructive pulmonary disease: randomized controlled trial. J Med Internet Res. 2017 May 3;19(5):e144. doi: 10.2196/jmir.7116.
    1. Farias R, Sedeno M, Beaucage D, Drouin I, Ouellet I, Joubert A, Abimaroun R, Patel M, Rjeili MA, Bourbeau J. Innovating the treatment of COPD exacerbations: a phone interactive telesystem to increase COPD action plan adherence. BMJ Open Respir Res. 2019;6(1):e000379. doi: 10.1136/bmjresp-2018-000379.
    1. Mudiyanselage SB, Stevens J, Watts J, Toscano J, Kotowicz M, Steinfort C, Bell J, Byrnes J, Bruce S, Carter S, Hunter C, Barrand C, Hayles R. Personalised telehealth intervention for chronic disease management: a pilot randomised controlled trial. J Telemed Telecare. 2019 Jul;25(6):343–52. doi: 10.1177/1357633X18775850.
    1. Yadav UN, Hosseinzadeh H, Baral KP. Self-management and patient activation in COPD patients: an evidence summary of randomized controlled trials. Clin Epidemiol Glob Health. 2018 Sep;6(3):148–54. doi: 10.1016/j.cegh.2017.10.004.
    1. Wang T, Tan J, Xiao LD, Deng R. Effectiveness of disease-specific self-management education on health outcomes in patients with chronic obstructive pulmonary disease: an updated systematic review and meta-analysis. Patient Educ Couns. 2017 Aug;100(8):1432–46. doi: 10.1016/j.pec.2017.02.026.
    1. Jolly K, Sidhu M, Bates E, Majothi S, Sitch A, Bayliss S, Kim H, Jordan R. Systematic review of the effectiveness of community-based self-management interventions among primary care COPD patients. NPJ Prim Care Respir Med. 2018 Nov 23;28(1):44. doi: 10.1038/s41533-018-0111-9.
    1. Kruse C, Pesek B, Anderson M, Brennan K, Comfort H. Telemonitoring to manage chronic obstructive pulmonary disease: systematic literature review. JMIR Med Inform. 2019 Mar 20;7(1):e11496. doi: 10.2196/11496.
    1. Hong Y, Lee SH. Effectiveness of tele-monitoring by patient severity and intervention type in chronic obstructive pulmonary disease patients: a systematic review and meta-analysis. Int J Nurs Stud. 2019 Apr;92:1–15. doi: 10.1016/j.ijnurstu.2018.12.006.
    1. Yang F, Wang Y, Yang C, Hu H, Xiong Z. Mobile health applications in self-management of patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis of their efficacy. BMC Pulm Med. 2018 Sep 4;18(1):147. doi: 10.1186/s12890-018-0671-z.
    1. Bourbeau J, Collet J, Schwartzman K, Ducruet T, Nault D, Bradley C. Economic benefits of self-management education in COPD. Chest. 2006 Dec;130(6):1704–11. doi: 10.1378/chest.130.6.1704.
    1. Tabak M, Brusse-Keizer M, van der Valk P, Hermens H, Vollenbroek-Hutten M. A telehealth program for self-management of COPD exacerbations and promotion of an active lifestyle: a pilot randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2014;9:935–44. doi: 10.2147/COPD.S60179. doi: 10.2147/COPD.S60179.
    1. Stamenova V, Yang R, Engel K, Liang K, van Lieshout F, Lalingo E, Cheung A, Erwood A, Radina M, Greenwald A, Agarwal P, Sidhu A, Bhatia RS, Shaw J, Shafai R, Bhattacharyya O. Technology-enabled self-monitoring of chronic obstructive pulmonary disease with or without asynchronous remote monitoring: protocol for a randomized controlled trial. JMIR Res Protoc. 2019 Aug 19;8(8):e13920. doi: 10.2196/13920.
    1. van Lieshout F, Yang R, Stamenova V, Agarwal P, Cornejo D, Sidhu A, Engel K, Erwood A, Bhatia SR, Bhattacharya O, Shaw J. Evaluating the implementation of a remote monitoring program for chronic obstructive pulmonary disease using qualitative methods: a service design perspective (Preprint) J Med Interent Res. 2020:-. doi: 10.2196/preprints.18148. (forthcoming)
    1. Dewar M, Curry RW. Chronic obstructive pulmonary disease: diagnostic considerations. Am Fam Physician. 2006 Feb 15;73(4):669–76.
    1. Urbaniak G, Plous S. Research Randomizer. 2019. [2019-09-26].
    1. Connected Health Monitoring Kit. Cloud DX. [2019-04-04]. .
    1. Jones PW, Harding G, Berry P, Wiklund I, Chen W, Kline Leidy N. Development and first validation of the COPD assessment test. Eur Respir J. 2009 Sep;34(3):648–54. doi: 10.1183/09031936.00102509.
    1. Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580–6. doi: 10.1378/chest.93.3.580.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377–81. doi: 10.1016/j.jbi.2008.08.010.
    1. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN, REDCap Consortium The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208.
    1. Petkov J, Harvey P, Battersby M. The internal consistency and construct validity of the partners in health scale: validation of a patient rated chronic condition self-management measure. Qual Life Res. 2010 Sep;19(7):1079–85. doi: 10.1007/s11136-010-9661-1.
    1. Jones P, Quirk F, Baveystock C. The St George's respiratory questionnaire. Resp Med. 1991 Sep;85:25–31. doi: 10.1016/s0954-6111(06)80166-6.
    1. White R, Walker P, Roberts S, Kalisky S, White P. Bristol COPD knowledge questionnaire (BCKQ): testing what we teach patients about COPD. Chron Respir Dis. 2006;3(3):123–31. doi: 10.1191/1479972306cd117oa.
    1. Esteban C, Moraza J, Iriberri M, Aguirre U, Goiria B, Quintana JM, Aburto M, Capelastegui A. Outcomes of a telemonitoring-based program (telEPOC) in frequently hospitalized COPD patients. Int J Chron Obstruct Pulmon Dis. 2016;11:2919–30. doi: 10.2147/COPD.S115350. doi: 10.2147/COPD.S115350.
    1. McDowell JE, McClean S, FitzGibbon F, Tate S. A randomised clinical trial of the effectiveness of home-based health care with telemonitoring in patients with COPD. J Telemed Telecare. 2015 Mar;21(2):80–7. doi: 10.1177/1357633X14566575.
    1. Davis C, Bender M, Smith T, Broad J. Feasibility and acute care utilization outcomes of a post-acute transitional telemonitoring program for underserved chronic disease patients. Telemed J E Health. 2015 Sep;21(9):705–13. doi: 10.1089/tmj.2014.0181.
    1. Soriano JB, García-Río F, Vázquez-Espinosa E, Conforto JI, Hernando-Sanz A, López-Yepes L, Galera-Martínez R, Peces-Barba G, Gotera-Rivera CM, Pérez-Warnisher MT, Segrelles-Calvo G, Zamarro C, González-Ponce P, Ramos MI, Jafri S, Ancochea J. A multicentre, randomized controlled trial of telehealth for the management of COPD. Respir Med. 2018 Nov;144:74–81. doi: 10.1016/j.rmed.2018.10.008.
    1. Walker PP, Pompilio PP, Zanaboni P, Bergmo TS, Prikk K, Malinovschi A, Montserrat JM, Middlemass J, Šonc S, Munaro G, Marušič D, Sepper R, Rosso R, Siriwardena AN, Janson C, Farré R, Calverley PM, Dellaca' RL. Telemonitoring in chronic obstructive pulmonary disease (CHROMED). A randomized clinical trial. Am J Respir Crit Care Med. 2018 Sep 1;198(5):620–8. doi: 10.1164/rccm.201712-2404OC.
    1. Boer L, Bischoff E, van der Heijden M, Lucas P, Akkermans R, Vercoulen J, Heijdra Y, Assendelft W, Schermer T. A smart mobile health tool versus a paper action plan to support self-management of chronic obstructive pulmonary disease exacerbations: randomized controlled trial. JMIR Mhealth Uhealth. 2019 Oct 9;7(10):e14408. doi: 10.2196/14408.
    1. Pinnock H, Hanley J, McCloughan L, Todd A, Krishan A, Lewis S, Stoddart A, van der Pol M, MacNee W, Sheikh A, Pagliari C, McKinstry B. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial. Br Med J. 2013 Oct 17;347:f6070. doi: 10.1136/bmj.f6070.
    1. Achelrod D, Schreyögg J, Stargardt T. Health-economic evaluation of home telemonitoring for COPD in Germany: evidence from a large population-based cohort. Eur J Health Econ. 2017 Sep;18(7):869–82. doi: 10.1007/s10198-016-0834-x.
    1. Pedone C, Chiurco D, Scarlata S, Incalzi RA. Efficacy of multiparametric telemonitoring on respiratory outcomes in elderly people with COPD: a randomized controlled trial. BMC Health Serv Res. 2013 Mar 6;13:82. doi: 10.1186/1472-6963-13-82.
    1. Lyth J, Lind L, Persson HL, Wiréhn AB. Can a telemonitoring system lead to decreased hospitalization in elderly patients? J Telemed Telecare. 2019 Jul 10;:1357633X19858178. doi: 10.1177/1357633X19858178. epub ahead of print.
    1. Shany T, Hession M, Pryce D, Roberts M, Basilakis J, Redmond S, Lovell N, Schreier G. A small-scale randomised controlled trial of home telemonitoring in patients with severe chronic obstructive pulmonary disease. J Telemed Telecare. 2017 Aug;23(7):650–6. doi: 10.1177/1357633X16659410.
    1. McLean S, Nurmatov U, Liu JL, 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):e739–49. doi: 10.3399/bjgp12X658269.
    1. Bischoff EW, Hamd DH, Sedeno M, Benedetti A, Schermer TR, Bernard S, Maltais F, Bourbeau J. Effects of written action plan adherence on COPD exacerbation recovery. Thorax. 2011 Jan;66(1):26–31. doi: 10.1136/thx.2009.127621.
    1. Riis HC, Jensen MH, Cichosz SL, Hejlesen OK. Prediction of exacerbation onset in chronic obstructive pulmonary disease patients. J Med Eng Technol. 2016;40(1):1–7. doi: 10.3109/03091902.2015.1105317.
    1. Udsen FW, Lilholt PH, Hejlesen O, Ehlers L. Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish 'TeleCare North' cluster-randomised trial. BMJ Open. 2017 May 17;7(5):e014616. doi: 10.1136/bmjopen-2016-014616.

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