What is the clinical evidence from this study?

Study design: RCT. Population: Chronic Heart Failure (n=220). Intervention: Telemonitoring added to ICT guided disease management vs. ICT guided disease management alone. Primary outcome: Composite score of death from any cause, first readmission for HF, and change in quality of life (MLHFQ).

July 13, 2011Open Access

The value of INnovative ICT guided disease management combined with Telemonitoring in OUtpatient clinics for Chronic Heart failure patients. Design and methodology of the IN TOUCH study: a multicenter randomised trial

Key Result

This paper is a study protocol for the IN TOUCH trial and does not report clinical results.

Study Design

Type

RCT (n=220)

Blinding

Open-label with blinded endpoint adjudication

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does telemonitoring added to ICT guided disease management improve a composite of death, HF readmission, and quality of life in patients with worsening chronic heart failure?

Population

A planned multicenter randomized trial of 220 adult patients with worsening chronic heart failure and LVEF ≤45%, followed for 9 months.

Intervention

ICT guided disease management (DM) combined with telemonitoring (weighing scale, blood pressure meter, ECG, and health monitor) for 9 months.

Comparator

ICT guided disease management (DM) alone for 9 months.

Outcome

Composite score of: 1) death from any cause during follow-up, 2) first readmission for HF, and 3) change in quality of life compared to baseline assessed by the Minnesota Living with Heart failure Questionnaire (MLHFQ) at 9 months.composite

The IN TOUCH study is designed to evaluate whether adding telemonitoring to ICT-guided disease management improves clinical outcomes and quality of life in patients with worsening heart failure.

Limitations

No information is currently available regarding the sensitivity of the composite endpoint in a setting of new onset or worsening HF patients

Abstract

BACKGROUND: Although the value of telemonitoring in heart failure patients is increasingly studied, little is known about the value of the separate components of telehealth: ICT guided disease management and telemonitoring. The aim of this study is to investigate the value of telemonitoring added to ICT guided disease management (DM) on the quality and efficiency of care in patients with chronic heart failure (CHF) after a hospitalisation. METHODS/DESIGN: The study is divided in two arms; a control arm (DM) and an intervention arm (DM+TM) in 10 hospitals in the Netherlands. In total 220 patients will be included after worsening of CHF (DM: N = 90, DM+TM: N = 130). Total follow-up will be 9 months. Data will be collected at inclusion and then after 2 weeks, 4.5 and 9 months. The primary endpoint of this study is a composite score of: 1: death from any cause during the follow-up of the study, 2: first readmission for HF and 3: change in quality of life compared to baseline, assessed by the Minnesota Living with Heart failure Questionnaire. The study has started in December 2009 and results are expected in 2012. CONCLUSIONS: The IN TOUCH study is the first to investigate the effect of telemonitoring on top of ICT guided DM on the quality and efficiency of care in patients with worsening HF and will use a composite score as its primary endpoint. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1898.

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