TY - JOUR
T1 - A smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on hospital admissions
T2 - the ToDo-CR randomised controlled trial study protocol
AU - Patterson, Kacie
AU - Davey, Rachel
AU - Keegan, Richard
AU - Niyonsenga, Theophile
AU - Mohanty, Itismita
AU - van Berlo, Sander
AU - Freene, Nicole
N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Funding Information:
Contributors KP, RD, RK, IM, TN, SvB and NF participated in the design of the study and development of the trial protocol. KP drafted the manuscript and all authors contributed to subsequent drafts. All authors read and approved the final manuscript. Funding This work was supported by a Medical Research Future Fund grant number (1184607). The funding organisation was not involved in the writing of this manuscript. The Medical Research Future Fund conducts periodical audits of trial conduct.
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/12/15
Y1 - 2020/12/15
N2 - INTRODUCTION: Cardiac rehabilitation (CR) is recommended for secondary prevention of cardiovascular disease and reducing the risk of repeat cardiac events. Physical activity is a core component of CR; however, studies show that participants remain largely sedentary. Sedentary behaviour is an independent risk factor for all-cause mortality. Strategies to encourage sedentary behaviour change are needed. This study will explore the effectiveness and costs of a smartphone application (Vire) and an individualised online behaviour change program (ToDo-CR) in reducing sedentary behaviour, all-cause hospital admissions and emergency department visits over 12 months after commencing CR.METHODS AND ANALYSIS: A multicentre, assessor-blind parallel randomised controlled trial will be conducted with 144 participants (18+ years). Participants will be recruited from three phase-II CR centres. They will be assessed on admission to CR and randomly assigned (1:1) to one of two groups: CR plus the ToDo-CR 6-month programme or usual care CR. Both groups will be re-assessed at 6 months and 12 months for the primary outcome of all-cause hospital admissions and presentations to the emergency department. Accelerometer-measured changes in sedentary behaviour and physical activity will also be assessed. Logistic regression models will be used for the primary outcome of hospital admissions and emergency department visits. Methods for repeated measures analysis will be used for all other outcomes. A cost-effectiveness analysis will be conducted to evaluate the effects of the intervention on the rates of hospital admissions and emergency department visits within the 12 months post commencing CR.ETHICS AND DISSEMINATION: This study received ethical approval from the Australian Capital Territory Health (2019.ETH.00162), Calvary Public Hospital Bruce (20-2019) and the University of Canberra (HREC-2325) Human Research Ethics Committees (HREC). Results will be disseminated through peer-reviewed academic journals. Results will be made available to participants on request.TRIAL REGISTRATION NUMBER: ACTRN12619001223123.
AB - INTRODUCTION: Cardiac rehabilitation (CR) is recommended for secondary prevention of cardiovascular disease and reducing the risk of repeat cardiac events. Physical activity is a core component of CR; however, studies show that participants remain largely sedentary. Sedentary behaviour is an independent risk factor for all-cause mortality. Strategies to encourage sedentary behaviour change are needed. This study will explore the effectiveness and costs of a smartphone application (Vire) and an individualised online behaviour change program (ToDo-CR) in reducing sedentary behaviour, all-cause hospital admissions and emergency department visits over 12 months after commencing CR.METHODS AND ANALYSIS: A multicentre, assessor-blind parallel randomised controlled trial will be conducted with 144 participants (18+ years). Participants will be recruited from three phase-II CR centres. They will be assessed on admission to CR and randomly assigned (1:1) to one of two groups: CR plus the ToDo-CR 6-month programme or usual care CR. Both groups will be re-assessed at 6 months and 12 months for the primary outcome of all-cause hospital admissions and presentations to the emergency department. Accelerometer-measured changes in sedentary behaviour and physical activity will also be assessed. Logistic regression models will be used for the primary outcome of hospital admissions and emergency department visits. Methods for repeated measures analysis will be used for all other outcomes. A cost-effectiveness analysis will be conducted to evaluate the effects of the intervention on the rates of hospital admissions and emergency department visits within the 12 months post commencing CR.ETHICS AND DISSEMINATION: This study received ethical approval from the Australian Capital Territory Health (2019.ETH.00162), Calvary Public Hospital Bruce (20-2019) and the University of Canberra (HREC-2325) Human Research Ethics Committees (HREC). Results will be disseminated through peer-reviewed academic journals. Results will be made available to participants on request.TRIAL REGISTRATION NUMBER: ACTRN12619001223123.
KW - complementary medicine
KW - coronary heart disease
KW - health informatics
KW - myocardial infarction
KW - preventive medicine
KW - rehabilitation medicine
UR - http://www.scopus.com/inward/record.url?scp=85097904140&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-040479
DO - 10.1136/bmjopen-2020-040479
M3 - Article
C2 - 33323435
SN - 2044-6055
VL - 10
SP - 1
EP - 13
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e040479
ER -
