Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial

Dionne Kessing, Johan Denollet, Jos Widdershoven, Nina Kupper, Dionne Kessing, Johan Denollet, Jos Widdershoven, Nina Kupper

Abstract

Background: Frequent rehospitalisations and poorer survival chances in heart failure (HF) patients may partly be explained by poor medication adherence. There are multiple medication-related reasons for suboptimal adherence, but psychological reasons may also be important. A novel TELEmonitoring device may improve MEDication adherence in HF patients (TELEMED-HF). TELEMED-HF is a randomized, controlled clinical intervention trial designed to examine (1) the efficacy and cost-efficiency of an electronic medication adherence support system in improving and monitoring HF patients' medication adherence; (2) the effect of medication adherence on hospitalizations and health care consumption; as well as on (3) clinical characteristics, and Quality of Life (QoL); and (4) clinical, sociodemographic, and psychological determinants of medication adherence.

Methods/design: Consecutive patients with chronic, systolic HF presenting to the outpatient clinic of the TweeSteden Hospital, The Netherlands, will be approached for study participation and randomly assigned (1:1) following blocked randomization procedures to the intervention (n = 200) or usual care arm (n = 200). Patients in the intervention arm use the medication support device for six months in addition to usual care. Post-intervention, patients return to usual care only and all patients participate in four follow-up occasions over 12 months. Primary endpoints comprise objective and subjective medication adherence, healthcare consumption, number of hospitalizations, and cost-effectiveness. Secondary endpoints include disease severity, physical functioning, and QoL.

Discussion: The TELEMED-HF study will provide us a comprehensive understanding of medication adherence in HF patients, and will show whether telemonitoring is effective and cost-efficient in improving adherence and preventing hospitalization in HF patients.

Trial registration number: NCT01347528.

Figures

Figure 1
Figure 1
Timeline study procedure. The figure shows a timeline of the study procedure.

References

    1. Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES. et al.Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011;123:e18–e209. doi: 10.1161/CIR.0b013e3182009701.
    1. Stewart S, MacIntyre K, Capewell S, McMurray JJ. Heart failure and the aging population: an increasing burden in the 21st century? Heart. 2003;89:49–53. doi: 10.1136/heart.89.1.49.
    1. Wieren SvR, Rutten FH, (Julius centrum) Volksgezondheid Toekomst Verkenning, Nationaal Kompas Volksgezondheid. Bilthoven: RIVM; 2008. Welke zorg gebruiken patiënten en wat zijn de kosten?
    1. Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW. et al.ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM) Eur Heart J. 2008;29:2388–2442.
    1. van der Wal MH, Jaarsma T, van Veldhuisen DJ. Non-compliance in patients with heart failure; how can we manage it? Eur J Heart Fail. 2005;7:5–17. doi: 10.1016/j.ejheart.2004.04.007.
    1. Wu JR, Moser DK, Chung ML, Lennie TA. Objectively Measured, but Not Self-Reported, Medication Adherence Independently Predicts Event-Free Survival in Patients With Heart Failure. Journal of Cardiac Failure. 2008;14:203–210. doi: 10.1016/j.cardfail.2007.11.005.
    1. Wu JR, Moser DK, De Jong MJ, Rayens MK, Chung ML, Riegel B, Lennie TA. Defining an evidence-based cutpoint for medication adherence in heart failure. Am Heart J. 2009;157:285–291. doi: 10.1016/j.ahj.2008.10.001.
    1. Bundkirchen A, Schwinger RHG. Epidemiology and economic burden of chronic heart failure. Eur Heart J Suppl. 2004;6:D57–60.
    1. Mortara A, Pinna GD, Johnson P, Maestri R, Capomolla S, La Rovere MT, Ponikowski P, Tavazzi L, Sleight P. Home telemonitoring in heart failure patients: the HHH study (Home or Hospital in Heart Failure) Eur J Heart Fail. 2009;11:312–318. doi: 10.1093/eurjhf/hfp022.
    1. Schmidt S, Sheikzadeh S, Beil B, Patten M, Stettin J. Acceptance of telemonitoring to enhance medication compliance in patients with chronic heart failure. Telemed J E Health. 2008;14:426–433. doi: 10.1089/tmj.2007.0076.
    1. Clarke M, Shah A, Sharma U. Systematic review of studies on telemonitoring of patients with congestive heart failure: a meta-analysis. J Telemed Telecare. 2011;17:7–14. doi: 10.1258/jtt.2010.100113.
    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;334:942. doi: 10.1136/bmj.39156.536968.55.
    1. Cleland JG, Coletta AP, Buga L, Antony R, Pellicori P, Freemantle N, Clark AL. Clinical trials update from the American Heart Association Meeting 2010: EMPHASIS-HF, RAFT, TIM-HF, Tele-HF, ASCEND-HF, ROCKET-AF, and PROTECT. Eur J Heart Fail. 2011;13:460–465. doi: 10.1093/eurjhf/hfr015.
    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;146:705–712. doi: 10.1016/S0002-8703(03)00393-4.
    1. Wu JR, Moser DK, Chung ML, Lennie TA. Predictors of medication adherence using a multidimensional adherence model in patients with heart failure. J Card Fail. 2008;14:603–614. doi: 10.1016/j.cardfail.2008.02.011.
    1. van der Wal MH, Jaarsma T. Adherence in heart failure in the elderly: problem and possible solutions. Int J Cardiol. 2008;125:203–208. doi: 10.1016/j.ijcard.2007.10.011.
    1. Granger BB, Ekman I, Granger CB, Ostergren J, Olofsson B, Michelson E, McMurray JJV, Yusuf S, Pfeffer MA, Swedberg K. Adherence to medication according to sex and age in the CHARM programme. Eur J Heart Fail. 2009;11:1092–1098. doi: 10.1093/eurjhf/hfp142.
    1. Ekman I, Andersson G, Boman K, Charlesworth A, Cleland JGF, Poole-Wilson P, Swedberg K. Adherence and perception of medication in patients with chronic heart failure during a five-year randomised trial. Patient Education and Counseling. 2006;61:348–353. doi: 10.1016/j.pec.2005.04.005.
    1. Kempen GI, Brilman EI, Ormel J. The Mini Mental Status Examination. Normative data and a comparison of a 12-item and 20-item version in a sample survey of community-based elderly. Tijdschr Gerontol Geriatr. 1995;26:163–172.
    1. Hakkaart-van Roijen L. Manual Trimbos/iMTA questionnaire for costs associated with psychiatric illness (in Dutch) Rotterdam: Institute for Medical Technology Assessment; 2002.
    1. Hsieh FY, Lavori PW. Sample-size calculations for the Cox proportional hazards regression model with nonbinary covariates. Control Clin Trials. 2000;21:552–560. doi: 10.1016/S0197-2456(00)00104-5.
    1. Schiffer AA, Pelle AJ, Smith OR, Widdershoven JW, Hendriks EH, Pedersen SS. Somatic versus cognitive symptoms of depression as predictors of all-cause mortality and health status in chronic heart failure. J Clin Psychiatry. 2009;70:1667–1673. doi: 10.4088/JCP.08m04609.
    1. Chaudhry SI, Barton B, Mattera J, Spertus J, Krumholz HM. Randomized trial of Telemonitoring to Improve Heart Failure Outcomes (Tele-HF): study design. J Card Fail. 2007;13:709–714. doi: 10.1016/j.cardfail.2007.06.720.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner