Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial
Tomas Vetrovsky,
Michal Siranec,
Tereza Frybova,
Iulian Gant,
Miroslav Semerad,
Marie Miklikova,
Vaclav Bunc,
Jiri Vesely,
Jiri Stastny,
Martin Griva,
Jan Precek,
Radek Pelouch,
Jiri Parenica,
Jiri Jarkovsky,
Jan Belohlavek
Affiliations
Tomas Vetrovsky
Faculty of Physical Education and Sport, Charles University
Michal Siranec
2nd Department of Medicine – Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Tereza Frybova
2nd Department of Medicine – Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Iulian Gant
2nd Department of Medicine – Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Miroslav Semerad
Faculty of Physical Education and Sport, Charles University
Marie Miklikova
Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University
Vaclav Bunc
Faculty of Physical Education and Sport, Charles University
Jiri Vesely
Faculty of Medicine in Hradec Kralove, Charles University
Jiri Stastny
Department of Cardiology, Tomas Bata Regional Hospital
Martin Griva
Department of Cardiology, Tomas Bata Regional Hospital
Jan Precek
Department of Internal Medicine I - Cardiology, University Hospital Olomouc
Radek Pelouch
1st Department of Internal Medicine – Cardioangiology, Faculty of Medicine in Hradec Kralove, Charles University
Jiri Parenica
Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University
Jiri Jarkovsky
Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University
Jan Belohlavek
2nd Department of Medicine – Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Abstract Background Physical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients’ compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients. Objectives The WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients. Methods The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period. Discussion The trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients’ recruitment and impacted their physical activity patterns. Conclusions The present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results. Trial registration ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).
