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

J 2023

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

VETROVSKY, Tomas, Michal SIRANEC, Tereza FRYBOVA, Iulian GANT, Miroslav SEMERAD et. al.

Základní údaje

Originální název

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

Autoři

VETROVSKY, Tomas (203 Česká republika, garant), Michal SIRANEC (203 Česká republika), Tereza FRYBOVA (203 Česká republika), Iulian GANT (203 Česká republika), Miroslav SEMERAD (203 Česká republika), Marie MIKLÍKOVÁ (203 Česká republika, domácí), Vaclav BUNC (203 Česká republika), Jiri VESELY (203 Česká republika), Jiri STASTNY (203 Česká republika), Martin GRIVA (203 Česká republika), Jan PRECEK (203 Česká republika), Radek PELOUCH (203 Česká republika), Jiří PAŘENICA (203 Česká republika, domácí), Jiří JARKOVSKÝ (203 Česká republika, domácí) a Jan BELOHLAVEK (203 Česká republika)

Vydání

Trials, LONDON, BMC, 2023, 1745-6215

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.500 v roce 2022

Kód RIV

RIV/00216224:14110/23:00133353

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1186/s13063-023-07516-5

UT WoS

001048629400002

Klíčová slova anglicky

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

Štítky

14110211, 14119612, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 31. 1. 2024 13:43, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

VETROVSKY, Tomas, Michal SIRANEC, Tereza FRYBOVA, Iulian GANT, Miroslav SEMERAD, Marie MIKLÍKOVÁ, Vaclav BUNC, Jiri VESELY, Jiri STASTNY, Martin GRIVA, Jan PRECEK, Radek PELOUCH, Jiří PAŘENICA, Jiří JARKOVSKÝ a Jan BELOHLAVEK. 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. LONDON: BMC, 2023, roč. 24, č. 1, s. 1-7. ISSN 1745-6215. Dostupné z: https://dx.doi.org/10.1186/s13063-023-07516-5.

@article{2368153,
   author = {Vetrovsky, Tomas and Siranec, Michal and Frybova, Tereza and Gant, Iulian and Semerad, Miroslav and Miklíková, Marie and Bunc, Vaclav and Vesely, Jiri and Stastny, Jiri and Griva, Martin and Precek, Jan and Pelouch, Radek and Pařenica, Jiří and Jarkovský, Jiří and Belohlavek, Jan},
   article_location = {LONDON},
   article_number = {1},
   doi = {http://dx.doi.org/10.1186/s13063-023-07516-5},
   keywords = {Physical activity; Phone counseling; Tele-rehabilitation; Functional capacity; Six-minute walk test; Self-monitoring; Wearables; Garmin; Pragmatic trial; Intention-to-treat analysis},
   language = {eng},
   issn = {1745-6215},
   journal = {Trials},
   title = {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},
   url = {https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07516-5},
   volume = {24},
   year = {2023}
}

TY  - JOUR
ID  - 2368153
AU  - Vetrovsky, Tomas - Siranec, Michal - Frybova, Tereza - Gant, Iulian - Semerad, Miroslav - Miklíková, Marie - Bunc, Vaclav - Vesely, Jiri - Stastny, Jiri - Griva, Martin - Precek, Jan - Pelouch, Radek - Pařenica, Jiří - Jarkovský, Jiří - Belohlavek, Jan
PY  - 2023
TI  - 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
JF  - Trials
VL  - 24
IS  - 1
SP  - 1-7
EP  - 1-7
PB  - BMC
SN  - 17456215
KW  - Physical activity
KW  - Phone counseling
KW  - Tele-rehabilitation
KW  - Functional capacity
KW  - Six-minute walk test
KW  - Self-monitoring
KW  - Wearables
KW  - Garmin
KW  - Pragmatic trial
KW  - Intention-to-treat analysis
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07516-5
N2  - 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.
ER  -

VETROVSKY, Tomas, Michal SIRANEC, Tereza FRYBOVA, Iulian GANT, Miroslav SEMERAD, Marie MIKLÍKOVÁ, Vaclav BUNC, Jiri VESELY, Jiri STASTNY, Martin GRIVA, Jan PRECEK, Radek PELOUCH, Jiří PAŘENICA, Jiří JARKOVSKÝ a Jan BELOHLAVEK. 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. \textit{Trials}. LONDON: BMC, 2023, roč.~24, č.~1, s.~1-7. ISSN~1745-6215. Dostupné z: https://dx.doi.org/10.1186/s13063-023-07516-5.

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