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Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
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BMC Pulmonary Medicine
Published in: BMC Pulmonary Medicine 1/2021

Open Access 01-12-2021 | Cystic Fibrosis | Study protocol

A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF

Authors: Stephanie Thee, Mirjam Stahl, Rainald Fischer, Sivagurunathan Sutharsan, Manfred Ballmann, Axel Müller, Daniel Lorenz, Dominika Urbanski-Rini, Franziska Püschner, Volker Eric Amelung, Carola Fuchs, Marcus Alexander Mall

Published in: BMC Pulmonary Medicine | Issue 1/2021

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Abstract

Background

The extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure. Early detection of deterioration in lung function and optimising adherence are therefore crucial in CF care. We implement a randomized controlled trial to evaluate efficacy of telemonitoring of adherence, lung function, and health condition in combination with behavior change interventions using innovative digital technologies.

Methods

This is a multi-centre, randomized, controlled, non-blinded trial aiming to include 402 patients ≥ 12 years-of-age with CF. A standard-of-care arm is compared to an arm receiving objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video-conferencing, a self-management app and professional telephone coaching. The duration of the intervention phase is 18 months. The primary endpoint is time to the first protocol-defined pulmonary exacerbation. Secondary outcome measures include number of and time between pulmonary exacerbations, adherence to inhalation therapy, changes in forced expiratory volume in 1 s from baseline, number of hospital admissions, and changes in health-related quality of life. CF-associated medical treatment and care, and health care related costs will be assessed by explorative analysis in both arms.

Discussion

This study offers the opportunity to evaluate the effect of adherence interventions using telemedicine capable devices on adherence and lung health, possibly paving the way for implementation of telemedicine in routine care for patients with CF.
Trial registration: This study has been registered with the German Clinical Trials Register (Identifier: DRKS00024642, date of registration 01 Mar 2021, URL: https://​www.​drks.​de/​drks_​web/​navigate.​do?​navigationId=​trial.​HTML&​TRIAL_​ID=​DRKS00024642).
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Metadata
Title
A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF
Authors
Stephanie Thee
Mirjam Stahl
Rainald Fischer
Sivagurunathan Sutharsan
Manfred Ballmann
Axel Müller
Daniel Lorenz
Dominika Urbanski-Rini
Franziska Püschner
Volker Eric Amelung
Carola Fuchs
Marcus Alexander Mall
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Pulmonary Medicine / Issue 1/2021
Electronic ISSN: 1471-2466
DOI
https://doi.org/10.1186/s12890-021-01500-y

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Keynote webinar | Spotlight on medication adherence

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Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

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