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

Trials

Update

Radek Pelouch¹  Tereza Frybova²  Jan Belohlavek²  Iulian Gant²  Michal Siranec²  Marie Miklikova³  Jiri Parenica³  Jiri Stastny⁴  Martin Griva⁵  Jan Precek⁶  Jiri Vesely⁷  Miroslav Semerad⁸  Tomas Vetrovsky⁸  Vaclav Bunc⁸  Jiri Jarkovsky⁹ 

[1] 1st Department of Internal Medicine – Cardioangiology, Faculty of Medicine in Hradec Kralove, Charles University, Prague, Czech Republic;University Hospital Hradec Kralove, Hradec Králové, Czech Republic;2nd Department of Medicine – Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic;Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic;Department of Cardiology, Tomas Bata Regional Hospital, Zlin, Czech Republic;Department of Cardiology, Tomas Bata Regional Hospital, Zlin, Czech Republic;Innere Medizin I - Abteilung Für Kardiologie Und Internistische Intensivmedizin, Landesklinikum Mistelbach, Mistelbach, Austria;Department of Internal Medicine I - Cardiology, University Hospital Olomouc, Olomouc, Czech Republic;Faculty of Medicine in Hradec Kralove, Charles University, Prague, Czech Republic;Edumed S.R.O, Broumov, Czech Republic;Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic;Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic;

关键词: Physical activity;    Phone counseling;    Tele-rehabilitation;    Functional capacity;    Six-minute walk test;    Self-monitoring;    Wearables;    Garmin;    Pragmatic trial;    Intention-to-treat analysis;   

DOI  :  10.1186/s13063-023-07516-5

 received in 2023-05-13, accepted in 2023-07-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPhysical 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.ObjectivesThe 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.MethodsThe 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.DiscussionThe 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.ConclusionsThe 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 registrationClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

Fig. 8