Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching

Erja Mustonen, Iiris Hörhammer, Kristiina Patja, Pilvikki Absetz, Johanna Lammintakanen, Martti Talja, Risto Kuronen, Miika Linna, Erja Mustonen, Iiris Hörhammer, Kristiina Patja, Pilvikki Absetz, Johanna Lammintakanen, Martti Talja, Risto Kuronen, Miika Linna

Abstract

Background: Health coaching is a patient-centred approach to supporting self-management for the chronic conditions. However, long-term evidence of effectiveness of health coaching remains scarce. The object of this study was to evaluate the long-term effect of telephone health coaching (THC) on mortality and morbidity among people with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF)..

Methods: 1535 T2D, CAD and CHF patients with unmet treatment targets were randomly allocated into an intervention group (n = 1034) and control group (n = 501). Intervention group received monthly individual strength-based, autonomy supportive THC sessions (average 30 min) for behavior change with a specially trained nurse for 12 months additional to usual health care. Control group received usual health care services. The primary outcome was a composite of death from cardiovascular causes or non-fatal stroke or non-fatal myocardial infarction (AMI) or unstable angina pectoris (UAP) during a follow-up of 8 years Three other composite endpoints with distinct combinations of fatal and non-fatal cardiovascular events and death from any cause were used as secondary outcomes. Other outcomes followed were the most relevant components of the composite endpoints. Randomized controlled trial (RCT) data was linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year evaluation was conducted using intention-to-treat (ITT) and per-protocol (PP) analysis.

Results: The composite primary outcome event rate per 100 person years was lower in the intervention group (3.45) than in control group (3.88) in ITT -analysis, but the difference was not statistically significant (hazard ratio in the intervention group 0.87; 95% CI, 0.71 to 1.07; P = 0.19). In the subgroup (T2D, CAD/CHF) analysis, there were no statistically significant effects. The secondary PP-analysis showed statistically significant benefits for those who participated in the study.

Conclusions: No statistically significant effect of health coaching on mortality and morbidity was found in intention to treat analysis. The per protocol results suggest, however, that the intervention may be effective among patients who are willing and able to participate in health coaching. More research is needed to identify patients most likely to benefit from low-intensity health coaching.

Trial registration: NCT00552903 (registration date: the 1st of November 2007, updated the 3rd of February 2009).

Keywords: Coronary artery disease; Health coaching; Morbidity; Mortality; Type 2 diabetes.

Conflict of interest statement

The authors declare that they have no competing interest.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Kaplan-Meier estimates of the cumulative proportion of patients with a primary endpoint event in the intention to treat (ITT) analysis in telephone health coaching. The numbers of patients at risk in each study group in the end of each follow-up year are shown below the graph
Fig. 2
Fig. 2
Cox proportional hazard ratios (HR) for the primary, secondary and other outcomes in intention to treat (ITT) analysis. Abbreviations: CVD = cardio vascular disease, AMI = myocardial infarction, UAP = unstable angina pectoris, CABG = coronary artery bypass grafting, PTCA = Percutaneous transluminal coronary angioplasty, PVD = Peripheral vascular disease, CHF = cardiac heart failure

References

    1. The Diabetes Control and Complications Trial Research Group (DCCT) The effect of intensive treatment of diabetes on long-term complications in insulin –depend diabetes mellitus. N Engl J Med. 1993;329:1035–1036. doi: 10.1056/NEJM199309303291410.
    1. UK Prospective Diabetes Study Group (UKPDS) Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405–412. doi: 10.1136/bmj.321.7258.405.
    1. Gregg EW, Sattar N, Ali MK. The changing face of diabetes complications. Lancet Diabetes Endocrinol. 2016;4(6):537–547. doi: 10.1016/S2213-8587(16)30010-9.
    1. Gaede P, Lund-Andersen H, Parving H-H, et al. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(5):6–393. doi: 10.1056/NEJMoa021778.
    1. Eurostat 2014. (Accessed May 27, 2020).
    1. Angermayr L, Melchart D. Multifactorial lifestyle interventions in the primary and secondary prevention of cardiovascular disease and type 2 diabetes mellitus – a systematic review of randomized controlled trials. Ann Behav Med. 2010;40(1):49–64. doi: 10.1007/s12160-010-9206-4.
    1. Hayes E, MacCahon C, Panahi MR, et al. Alliance not compliance: coaching strategies to improve type 2 diabetes outcomes. J Am Assoc Nurse Pract. 2008;20(3):155–162. doi: 10.1111/j.1745-7599.2007.00297.x.
    1. Palmer S, Tubbs I, Whybrow A. Health coaching to facilitate to promotion of health behaviour and achievement of health-related goals. Int J Health Promot Educ. 2003;41(3):91–93. doi: 10.1080/14635240.2003.10806231.
    1. Olsen JM. Health coaching: a concept analysis. Nurs Forum. 2014;49(1):18–29. doi: 10.1111/nuf.12042.
    1. Kivelä K, Elo S, Kyngäs H, Kääriäinen M. The effects of health coaching on adult patient with chronic diseases: a systematic review. Patient Educ Couns. 2014;97(2):147–157. doi: 10.1016/j.pec.2014.07.026.
    1. Dennis S, Harris M, Lloyd J, et al. Do people with existing chronic conditions benefit from health coaching? A rapid review. Aust Health Rev. 2013;37(3):381–388. doi: 10.1071/AH13005.
    1. Olsen JM, Nesbitt BJ. Health coaching to improve healthy lifestyle behaviors: an integrative review. Am J Health Promot. 2010;25(1):e1–e12. doi: 10.4278/ajhp.090313-LIT-101.
    1. Lin W, Chien H, Willis G, et al. The effect of a telephone-based health coaching disease management program on medicaid members with chronic conditions. Med Care. 2012;50(1):91–98. doi: 10.1097/MLR.0b013e31822dcedf.
    1. Hale R, Giese J. Cost-effectiveness of health coaching. Prof Case Manag. 2017;22(5):228–238. doi: 10.1097/NCM.0000000000000223.
    1. Byrnes J, Elliott T, Vale MJ, et al. Coaching patients saves lives and money. Am J Med. 2018;131(4):421.e1. doi: 10.1016/j.amjmed.2017.10.019.
    1. Dejonghe L. Becker J, Froboese I. et al. A. 2017, long-term effectiveness of health coaching in rehabilitation and prevention: a systematic review. Patient Educ Couns. 2017;100(9):1643–1653. doi: 10.1016/j.pec.2017.04.012.
    1. Patja K, Absetz P, Auvinen A, Tokola K, Kytö J, Oksman E, Kuronen R, Ovaska T, Harno K, Nenonen M, Wiklund T, Kettunen R, Talja M. Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from the TERVA randomized controlled trial. BMC Health Serv Res. 2012;12(1):147. doi: 10.1186/1472-6963-12-147.
    1. Oksman E, Linna M, Hörhammer I, Lammintakanen J, Talja M. Cost-effectiveness analysis for a tele-based health coaching program for chronic disease in primary care. BMC Health Serv Res. 2017;17(1):138. doi: 10.1186/s12913-017-2088-4.
    1. Mustonen E, Hörhammer I, Absetz P, Patja K, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of health care and long-term care costs of telebased health coaching. Health Serv Res. 2020;55(2):211–217. doi: 10.1111/1475-6773.13251.
    1. Mustonen E. Telephone-based health coaching for chronic disease patients: evaluation of short- and long-term effectiveness of health benefits and costs: Dissertation in Social Sciences and Business Studies. University of Eastern Finland, Kuopio; 2021.
    1. Finnish Current Care Guidelines. Available from: .
    1. Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care: helping patients change behavior. New York: The Guilford Press; 2008.
    1. The Look AHEAD Research group. N Engl J Med. 2013;369(2):145–154. doi: 10.1056/NEJMoa1212914.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340(7748):698–702. doi: 10.1016/j.ijsu.2010.09.006.
    1. Brody T. Intent-to-treat analysis versus per protocol analysis. Clin Trials. 2nd ed. 2016. p. 173–201.
    1. Ranganathan P, Pramesh CS, Aggarwal R. Common pitfalls in statistical analysis: intention-to-treat versus per-protocol analysis. Perspect Clin Res. 2016;7(3):144–146. doi: 10.4103/2229-3485.184823.
    1. Karhula T, Vuorinen A-L, Rääpysjärvi K, et al. Telemonitoring and mobile-based health coaching among Finnish diabetic and heart disease patients: randomized controlled trial. J Med Internet Res. 2015;17:e 153. doi: 10.2196/jmir.4059.
    1. Härter M, Dirmaier J, Dwinger S, et al. Effectiveness of telephone-based health coaching for patients with chronic conditions: a randomized controlled trial. PLoS One. 2016;11(9):e0161269. doi: 10.1371/journal.pone.0161269.
    1. Ueki K, Sasako T, Kato M, Okazaki Y, Okahata S, Katsuyama H, Haraguchi M, Morita A, Ohashi K, Hara K, Morise A, Izumi K, Ohashi Y, Noda M, Kadowaki T, the J-DOIT3 Study Group Design of and rationale for the Japan diabetes optimal integrated treatment study for 3 major risk factors of cardiovascular diseases (J-DOIT3): a multicenter, open-label, randomized, parallel-group trial. BMJ Open Diabetes Res Care (Internet) 2016;4(1):e000123. doi: 10.1136/bmjdrc-2015-000123.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner