Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study

Patrick Ware, Amika Shah, Heather Joan Ross, Alexander Gordon Logan, Phillip Segal, Joseph Antony Cafazzo, Katarzyna Szacun-Shimizu, Myles Resnick, Tessy Vattaparambil, Emily Seto, Patrick Ware, Amika Shah, Heather Joan Ross, Alexander Gordon Logan, Phillip Segal, Joseph Antony Cafazzo, Katarzyna Szacun-Shimizu, Myles Resnick, Tessy Vattaparambil, Emily Seto

Abstract

Background: Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population.

Objective: This randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care.

Methods: A pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences.

Results: A total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF.

Conclusions: We recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care.

Trial registration: ClinicalTrials.gov NCT03127852; https://ichgcp.net/clinical-trials-registry/NCT03127852.

International registered report identifier (irrid): RR2-10.2196/resprot.8367.

Keywords: diabetes; heart failure; hypertension; mobile phone; multiple chronic conditions; telemedicine; telemonitoring; tertiary health care.

Conflict of interest statement

Conflicts of Interest: ES, HR, and JC are considered inventors of the Medly system under the intellectual property policies of the University Health Network and may benefit from future commercialization of the technology by University Health Network.

©Patrick Ware, Amika Shah, Heather Joan Ross, Alexander Gordon Logan, Phillip Segal, Joseph Antony Cafazzo, Katarzyna Szacun-Shimizu, Myles Resnick, Tessy Vattaparambil, Emily Seto. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 26.01.2022.

Figures

Figure 1
Figure 1
Screens of the Medly multiple chronic conditions app showing self-care feedback for (A) heart failure, (B) diabetes mellitus, and (C) hypertension.
Figure 2
Figure 2
Flow of patient participants through the trial.
Figure 3
Figure 3
Average combined and condition-specific adherence rates over time.

References

    1. Roberts KC, Rao DP, Bennett TL, Loukine L, Jayaraman GC. Prevalence and patterns of chronic disease multimorbidity and associated determinants in Canada. Health Promot Chronic Dis Prev Can. 2015 Aug;35(6):87–94. doi: 10.24095/hpcdp.35.6.01. doi: 10.24095/hpcdp.35.6.01.
    1. van Oostrom SH, Gijsen R, Stirbu I, Korevaar JC, Schellevis FG, Picavet HS, Hoeymans N. Time trends in prevalence of chronic diseases and multimorbidity not only due to aging: data from general practices and health surveys. PLoS One. 2016 Aug;11(8):e0160264. doi: 10.1371/journal.pone.0160264. PONE-D-15-13697
    1. Moffat K, Mercer SW. Challenges of managing people with multimorbidity in today's healthcare systems. BMC Fam Pract. 2015 Oct 14;16(1):129. doi: 10.1186/s12875-015-0344-4. 10.1186/s12875-015-0344-4
    1. Zulman DM, Chee CP, Wagner TH, Yoon J, Cohen DM, Holmes TH, Ritchie C, Asch SM. Multimorbidity and healthcare utilisation among high-cost patients in the US Veterans Affairs Health Care System. BMJ Open. 2015 Apr 16;5(4):e007771. doi: 10.1136/bmjopen-2015-007771. bmjopen-2015-007771
    1. Wodchis WP, Austin PC, Henry DA. A 3-year study of high-cost users of health care. Can Med Asso J. 2016 Feb 16;188(3):182–8. doi: 10.1503/cmaj.150064. cmaj.150064
    1. Siminerio LM. The role of technology and the chronic care model. J Diabetes Sci Technol. 2010 Mar 01;4(2):470–5. doi: 10.1177/193229681000400229.
    1. Noël PH, Parchman ML, Williams JW, Cornell JE, Shuko L, Zeber JE, Kazis LE, Lee AF, Pugh JA. The challenges of multimorbidity from the patient perspective. J Gen Intern Med. 2007 Dec;22 Suppl 3:419–24. doi: 10.1007/s11606-007-0308-z.
    1. Liddy C, Blazkho V, Mill K. Challenges of self-management when living with multiple chronic conditions: systematic review of the qualitative literature. Can Fam Physician. 2014 Dec;60(12):1123–33.
    1. Vassilev I, Rowsell A, Pope C, Kennedy A, O'Cathain A, Salisbury C, Rogers A. Assessing the implementability of telehealth interventions for self-management support: a realist review. Implement Sci. 2015;10:59. doi: 10.1186/s13012-015-0238-9. 10.1186/s13012-015-0238-9
    1. Seto E, Morita PP, Tomkun J, Lee TM, Ross H, Reid-Haughian C, Kaboff A, Mulholland D, Cafazzo JA. Implementation of a heart failure telemonitoring system in home care nursing: feasibility study. JMIR Med Inform. 2019 Jul 26;7(3):e11722. doi: 10.2196/11722. v7i3e11722
    1. Meystre S. The current state of telemonitoring: a comment on the literature. Telemed J E Health. 2005 Feb;11(1):63–9. doi: 10.1089/tmj.2005.11.63.
    1. Logan AG, Irvine MJ, McIsaac WJ, Tisler A, Rossos PG, Easty A, Feig DS, Cafazzo JA. Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics. Hypertension. 2012 Jul;60(1):51–7. doi: 10.1161/HYPERTENSIONAHA.111.188409. HYPERTENSIONAHA.111.188409
    1. Istepanian RS, Zitouni K, Harry D, Moutosammy N, Sungoor A, Tang B, Earle KA. Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes. J Telemed Telecare. 2009;15(3):125–8. doi: 10.1258/jtt.2009.003006.15/3/125
    1. Goldberg LR, Piette JD, Walsh MN, Frank TA, Jaski BE, Smith AL, Rodriguez R, Mancini DM, Hopton LA, Orav EJ, Loh E. Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial. Am Heart J. 2003 Oct;146(4):705–12. doi: 10.1016/S0002-8703(03)00393-4.S0002870303003934
    1. Liang HY, Lin LH, Chang CY, Wu FM, Yu S. Effectiveness of a nurse-led tele-homecare program for patients with multiple chronic illnesses and a high risk for readmission: a randomized controlled trial. J Nurs Scholarsh. 2021 Mar;53(2):161–70. doi: 10.1111/jnu.12622.
    1. Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.
    1. Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. Br Med J. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. bmj.39156.536968.55
    1. Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telemonitoring for congestive heart failure: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(2):68–76. doi: 10.1258/jtt.2009.090406.jtt.2009.090406
    1. Paré G, Moqadem K, Pineau G, St-Hilaire C. Clinical effects of home telemonitoring in the context of diabetes, asthma, heart failure and hypertension: a systematic review. J Med Internet Res. 2010;12(2):e21. doi: 10.2196/jmir.1357. v12i2e21
    1. Bowles KH, Holland DE, Horowitz DA. A comparison of in-person home care, home care with telephone contact and home care with telemonitoring for disease management. J Telemed Telecare. 2009;15(7):344–50. doi: 10.1258/jtt.2009.090118. 15/7/344
    1. Hamadi HY, Martinez D, Xu J, Silvera GA, Mallea JM, Hamadi W, Li X, Li Y, Zhao M. Effects of post-discharge telemonitoring on 30-day chronic obstructive pulmonary disease readmissions and mortality. J Telemed Telecare. 2020 Nov 11;:1357633X20970402. doi: 10.1177/1357633X20970402.
    1. Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan B, Anker SD, Telemedical Interventional Monitoring in Heart Failure Investigators Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873–80. doi: 10.1161/CIRCULATIONAHA.111.018473. CIRCULATIONAHA.111.018473
    1. Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm M, de BS, Perrin E, Baumann G, Gelbrich G, Boll H, Honold M, Koehler K, Kirwan B, Anker SD. Telemedicine in heart failure: pre-specified and exploratory subgroup analyses from the TIM-HF trial. Int J Cardiol. 2012 Nov 29;161(3):143–50. doi: 10.1016/j.ijcard.2011.09.007.S0167-5273(11)01718-9
    1. Scherr D, Kastner P, Kollmann A, Hallas A, Auer J, Krappinger H, Schuchlenz H, Stark G, Grander W, Jakl G, Schreier G, Fruhwald FM, MOBITEL Investigators, et al Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. J Med Internet Res. 2009 Aug 17;11(3):34–78. doi: 10.2196/jmir.1252. v11i3e34
    1. Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 09;363(24):2301–9. doi: 10.1056/nejmoa1010029.
    1. Cady R, Finkelstein S, Kelly A. A telehealth nursing intervention reduces hospitalizations in children with complex health conditions. J Telemed Telecare. 2009;15(6):317–20. doi: 10.1258/jtt.2009.090105.15/6/317
    1. Takahashi PY, Pecina JL, Upatising B, Chaudhry R, Shah ND, Van Houten H, Cha S, Croghan I, Naessens JM, Hanson GJ. 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):773–9. doi: 10.1001/archinternmed.2012.256. archinternmed.2012.256
    1. Darkins A, Ryan P, Kobb R, Foster L, Edmonson E, Wakefield B, Lancaster AE. Care Coordination/Home Telehealth: the systematic implementation of health informatics, home telehealth, and disease management to support the care of veteran patients with chronic conditions. Telemed J E Health. 2008 Dec;14(10):1118–26. doi: 10.1089/tmj.2008.0021.
    1. Noel HC, Vogel DC, Erdos JJ, Cornwall D, Levin F. Home telehealth reduces healthcare costs. Telemed J E Health. 2004 Jun;10(2):170–83. doi: 10.1089/tmj.2004.10.170.
    1. Wakefield BJ, Holman JE, Ray A, Scherubel M, Adams MR, Hillis SL, Rosenthal GE. Effectiveness of home telehealth in comorbid diabetes and hypertension: a randomized, controlled trial. Telemed J E Health. 2011 May;17(4):254–61. doi: 10.1089/tmj.2010.0176.
    1. Martín-Lesende I, Orruño E, Bilbao A, Vergara I, Cairo MC, Bayón JC, Reviriego E, Romo MI, Larrañaga J, Asua J, Abad R, Recalde E. Impact of telemonitoring home care patients with heart failure or chronic lung disease from primary care on healthcare resource use (the TELBIL study randomised controlled trial) BMC Health Serv Res. 2013 Mar 28;13:118. doi: 10.1186/1472-6963-13-118. 1472-6963-13-118
    1. Orozco-Beltran D, Sánchez-Molla M, Sanchez JJ, Mira JJ, ValCrònic Research Group Telemedicine in primary care for patients with chronic conditions: the valcrònic quasi-experimental study. J Med Internet Res. 2017 Dec 15;19(12):e400. doi: 10.2196/jmir.7677. v19i12e400
    1. Seto E, Ware P, Logan AG, Cafazzo JA, Chapman KR, Segal P, Ross HJ. Self-management and clinical decision support for patients with complex chronic conditions through the use of smartphone-based telemonitoring: randomized controlled trial protocol. JMIR Res Protoc. 2017 Nov 21;6(11):e229. doi: 10.2196/resprot.8367. v6i11e229
    1. Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system. Int J Med Inform. 2012 Aug;81(8):556–65. doi: 10.1016/j.ijmedinf.2012.03.001.S1386-5056(12)00056-1
    1. Sultan M, Kuluski K, McIsaac WJ, Cafazzo JA, Seto E. Turning challenges into design principles: telemonitoring systems for patients with multiple chronic conditions. Health Informatics J. 2019 Dec;25(4):1188–200. doi: 10.1177/1460458217749882.
    1. Seto E, Ross H, Tibbles A, Wong S, Ware P, Etchells E, Kobulnik J, Chibber T, Poon S. A mobile phone-based telemonitoring program for heart failure patients after an incidence of acute decompensation (Medly-Aid): protocol for a randomized controlled trial. JMIR Res Protoc. 2020 Jan 22;9(1):e15753. doi: 10.2196/15753. v9i1e15753
    1. Ezekowitz JA, O'Meara E, McDonald MA, Abrams H, Chan M, Ducharme A, Giannetti N, Grzeslo A, Hamilton PG, Heckman GA, Howlett JG, Koshman SL, Lepage S, McKelvie RS, Moe GW, Rajda M, Swiggum E, Virani SA, Zieroth S, Al-Hesayen A, Cohen-Solal A, D'Astous M, De S, Estrella-Holder E, Fremes S, Green L, Haddad H, Harkness K, Hernandez AF, Kouz S, LeBlanc M, Masoudi FA, Ross HJ, Roussin A, Sussex B. 2017 comprehensive update of the canadian cardiovascular society guidelines for the management of heart failure. Can J Cardiol. 2017 Nov;33(11):1342–433. doi: 10.1016/j.cjca.2017.08.022.S0828-282X(17)30973-X
    1. Ivers NM, Jiang M, Alloo J, Singer A, Ngui D, Casey CG, Yu CH. Diabetes Canada 2018 clinical practice guidelines: key messages for family physicians caring for patients living with type 2 diabetes. Can Fam Physician. 2019 Jan;65(1):14–24. 65/1/14
    1. Cash J, Glass C, Gunter D, Bradley K. Canadian Family Practice Guidelines. New York: Springer; 2019. Hypertension (HTN), Canadian Guideline.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Lorig K, Stewart A, Ritter P, Gonzalez V, Laurent D, Lynch J. Outcome Measures for Health Education and Other Health Care Interventions. Thousand Oaks, CA: SAGE Publications; 1996.
    1. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001;4(6):256–62.
    1. Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265–73. doi: 10.1016/j.jclinepi.2014.06.009.S0895-4356(14)00235-2
    1. Riegel B, Lee CS, Dickson VV, Carlson B. An update on the self-care of heart failure index. J Cardiovasc Nurs. 2009;24(6):485–97. doi: 10.1097/JCN.0b013e3181b4baa0.
    1. Bennett SJ, Oldridge NB, Eckert GJ, Embree JL, Browning S, Hou N, Chui M, Deer M, Murray MD. Comparison of quality of life measures in heart failure. Nurs Res. 2003;52(4):207–16. doi: 10.1097/00006199-200307000-00001.
    1. Venkatesh V, Morris M, Davis G, Davis F. User acceptance of information technology: toward a unified view. MIS Q. 2003;27(3):425. doi: 10.2307/30036540.
    1. Hsieh H, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277–88. doi: 10.1177/1049732305276687.15/9/1277
    1. Kraef C, van der Meirschen M, Free C. Digital telemedicine interventions for patients with multimorbidity: a systematic review and meta-analysis. BMJ Open. 2020 Oct 13;10(10):e036904. doi: 10.1136/bmjopen-2020-036904. bmjopen-2020-036904
    1. Ware P, Ross HJ, Cafazzo JA, Laporte A, Gordon K, Seto E. User-centered adaptation of an existing heart failure telemonitoring program to ensure sustainability and scalability: qualitative study. JMIR Cardio. 2018 Dec 06;2(2):e11466. doi: 10.2196/11466. v2i2e11466
    1. Olivier CB, Middleton SK, Purington N, Shashidhar S, Hereford J, Mahaffey KW, Turakhia MP. Why digital health trials can fail: lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation. Cardiovas Digit Health J. 2021 Apr;2(2):101–8. doi: 10.1016/j.cvdhj.2021.01.003.
    1. Gordon K, Gray CS, Dainty K, DeLacy J, Ware P, Seto E. Exploring an innovative care model and telemonitoring for the management of patients with complex chronic needs: qualitative description study. JMIR Nurs. 2020;3(1):e15691. doi: 10.2196/15691. v3i1e15691
    1. Gordon K, Dainty K, Gray CS, DeLacy J, Shah A, Resnick M, Seto E. Experiences of complex patients with telemonitoring in a nurse-led model of care: multimethod feasibility study. JMIR Nurs. 2020 Sep 29;3(1):e22118. doi: 10.2196/22118. v3i1e22118
    1. Kastner M, Hayden L, Wong G, Lai Y, Makarski J, Treister V, Chan J, Lee JH, Ivers NM, Holroyd-Leduc J, Straus SE. Underlying mechanisms of complex interventions addressing the care of older adults with multimorbidity: a realist review. BMJ Open. 2019 Apr 03;9(4):e025009. doi: 10.1136/bmjopen-2018-025009. bmjopen-2018-025009
    1. de la Pisa BP, Palou-Lobato M, Calzada CM, García-Lozano MJ. Effectiveness of interventions based on telemedicine on health outcomes in patients with multimorbidity in primary care: a systematic review. Aten Primaria. 2020 Dec;52(10):759–69. doi: 10.1016/j.aprim.2019.08.004. S0212-6567(19)30351-8
    1. Bernocchi P, Vitacca M, La Rovere MT, Volterrani M, Galli T, Baratti D, Paneroni M, Campolongo G, Sposato B, Scalvini S. Home-based telerehabilitation in older patients with chronic obstructive pulmonary disease and heart failure: a randomised controlled trial. Age Ageing. 2018 Dec 01;47(1):82–8. doi: 10.1093/ageing/afx146.4097568
    1. Rifkin DE, Abdelmalek JA, Miracle CM, Low C, Barsotti R, Rios P, Stepnowsky C, Agha Z. Linking clinic and home: a randomized, controlled clinical effectiveness trial of real-time, wireless blood pressure monitoring for older patients with kidney disease and hypertension. Blood Press Monit. 2013 Feb;18(1):8–15. doi: 10.1097/MBP.0b013e32835d126c. 00126097-201302000-00002
    1. Wakefield BJ, Holman JE, Ray A, Scherubel M, Adams MR, Hills SL, Rosenthal GE. Outcomes of a home telehealth intervention for patients with diabetes and hypertension. Telemed J E Health. 2012 Oct;18(8):575–9. doi: 10.1089/tmj.2011.0237.
    1. Yoo HJ, Park MS, Kim TN, Yang SJ, Cho GJ, Hwang TG, Baik SH, Choi DS, Park GH, Choi KM. A ubiquitous chronic disease care system using cellular phones and the internet. Diabet Med. 2009 Jun;26(6):628–35. doi: 10.1111/j.1464-5491.2009.02732.x.DME2732

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