Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial

Emily Seto, Kevin J Leonard, Joseph A Cafazzo, Jan Barnsley, Caterina Masino, Heather J Ross, Emily Seto, Kevin J Leonard, Joseph A Cafazzo, Jan Barnsley, Caterina Masino, Heather J Ross

Abstract

Background: Previous trials of telemonitoring for heart failure management have reported inconsistent results, largely due to diverse intervention and study designs. Mobile phones are becoming ubiquitous and economical, but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined.

Objective: The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes.

Methods: One hundred patients were recruited from a heart function clinic and randomized into telemonitoring and control groups. The telemonitoring group (N = 50) took daily weight and blood pressure readings and weekly single-lead ECGs, and answered daily symptom questions on a mobile phone over 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patients' mobile phones and alerts to a cardiologist's mobile phone as required.

Results: Baseline questionnaires were completed and returned by 94 patients, and 84 patients returned post-study questionnaires. About 70% of telemonitoring patients completed at least 80% of their possible daily readings. The change in quality of life from baseline to post-study, as measured with the Minnesota Living with Heart Failure Questionnaire, was significantly greater for the telemonitoring group compared to the control group (P = .05). A between-group analysis also found greater post-study self-care maintenance (measured with the Self-Care of Heart Failure Index) for the telemonitoring group (P = .03). Brain natriuretic peptide (BNP) levels, self-care management, and left ventricular ejection fraction (LVEF) improved significantly for both groups from baseline to post-study, but did not show a between-group difference. However, a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant improvements from baseline to post-study in BNP (decreased by 150 pg/mL, P = .02), LVEF (increased by 7.4%, P = .005) and self-care maintenance (increased by 7 points, P = .05) and management (increased by 14 points, P = .03), while the control group did not. No differences were found between the telemonitoring and control groups in terms of hospitalization, mortality, or emergency department visits, but the trial was underpowered to detect differences in these metrics.

Conclusions: Our findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system. The use of the mobile phone-based system had high adherence and was feasible for patients, including the elderly and those with no experience with mobile phones.

Trial registration: ClinicalTrials.gov NCT00778986.

Conflict of interest statement

None

Figures

Figure 1
Figure 1
Flow of participants through the trial.
Figure 2
Figure 2
Sample message sent to patient’s mobile phone.
Figure 3
Figure 3
Weekly adherence to completing all daily measurements.

References

    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. BMJ. 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. Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A. A meta-analysis of remote monitoring of heart failure patients. J Am Coll Cardiol. 2009 Oct 27;54(18):1683–94. doi: 10.1016/j.jacc.2009.08.017.S0735-1097(09)02921-0
    1. Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, 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. 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 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;11(3):e34. doi: 10.2196/jmir.1252. v11i3e34
    1. Riegel B, Vaughan Dickson V, Goldberg LR, Deatrick JA. Factors associated with the development of expertise in heart failure self-care. Nurs Res. 2007 Jul;56(4):235–43. doi: 10.1097/01.NNR.0000280615.75447.f7.00006199-200707000-00003
    1. Riegel B, Lee CS, Dickson VV, Carlson B. An update on the self-care of heart failure index. J Cardiovasc Nurs. 2009 Dec;24(6):485–97. doi: 10.1097/JCN.0b013e3181b4baa0.
    1. Urbaniak GC. Plous S Research Randomizer. [2011-11-16].
    1. Riegel B, Moser DK, Glaser D, Carlson B, Deaton C, Armola R, Sethares K, Shively M, Evangelista L, Albert N. The Minnesota Living With Heart Failure Questionnaire: sensitivity to differences and responsiveness to intervention intensity in a clinical population. Nurs Res. 2002 Aug;51(4):209–18.
    1. Riegel B, Carlson B, Moser DK, Sebern M, Hicks FD, Roland V. Psychometric testing of the self-care of heart failure index. J Card Fail. 2004 Aug;10(4):350–60.S1071916403008017
    1. Rector TS. Cohn JN Minnesota Living With Heart Failure Questionnaire. [2011-08-08]. .
    1. Hsieh HF, 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. Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Perceptions and Experiences of Heart Failure Patients and Clinicians on the Use of Mobile Phone-Based Telemonitoring. J Med Internet Res. 2012 Oct 21;14(1):e25–65. doi: 10.2196/jmir.1912. v14i1e25
    1. Albert NM, Yancy CW, Liang L, Zhao X, Hernandez AF, Peterson ED, Cannon CP, Fonarow GC. Use of aldosterone antagonists in heart failure. JAMA. 2009 Oct 21;302(15):1658–65. doi: 10.1001/jama.2009.1493.302/15/1658
    1. Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B, EMPHASIS-HF Study Group Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11–21. doi: 10.1056/NEJMoa1009492.
    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 9;363(24):2301–9. doi: 10.1056/NEJMoa1010029. 15/7/344
    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

Source: PubMed

3
Subscribe