Dataset Information

A smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on hospital admissions: the ToDo-CR randomised controlled trial study protocol.

ABSTRACT:

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.

SUBMITTER: Patterson K

PROVIDER: S-EPMC7745513 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

A smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on hospital admissions: the ToDo-CR randomised controlled trial study protocol.

Patterson Kacie K Davey Rachel R Keegan Richard R Niyonsenga Theophile T Mohanty Itismita I van Berlo Sander S Freene Nicole N

BMJ open 20201215 12

<h4>Introduction</h4>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) a ...[more]

PMID: 33323435

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Project description:BackgroundPeople with coronary heart disease are at an increased risk of morbidity and mortality even if they attend cardiac rehabilitation. High sedentary behavior levels potentially contribute to this morbidity. Smartphone apps may be feasible to facilitate sedentary behavior reductions and lead to reduced health care use.ObjectiveWe aimed to test the effect of a sedentary behavior change smartphone app (Vire app and ToDo-CR program) as an adjunct to cardiac rehabilitation on hospital admissions and emergency department (ED) presentations over 12 months.MethodsA multicenter, randomized controlled trial was conducted with 120 participants recruited from 3 cardiac rehabilitation programs. Participants were randomized 1:1 to cardiac rehabilitation plus the fully automated 6-month Vire app and ToDo-CR program (intervention) or usual care (control). The primary outcome was nonelective hospital admissions and ED presentations over 12 months. Secondary outcomes including accelerometer-measured sedentary behavior, BMI, waist circumference, and quality of life were recorded at baseline and 6 and 12 months. Logistic regression models were used to analyze the primary outcome, and linear mixed-effects models were used to analyze secondary outcomes. Data on intervention and hospital admission costs were collected, and the incremental cost-effectiveness ratios (ICERs) were calculated.ResultsParticipants were, on average, aged 62 (SD 10) years, and the majority were male (93/120, 77.5%). The intervention group were more likely to experience all-cause (odds ratio [OR] 1.54, 95% CI 0.58-4.10; P=.39) and cardiac-related (OR 3.26, 95% CI 0.84-12.55; P=.09) hospital admissions and ED presentations (OR 2.07, 95% CI 0.89-4.77; P=.09) than the control group. Despite this, cardiac-related hospital admission costs were lower in the intervention group over 12 months (Aus $252.40 vs Aus $859.38; P=.24; a currency exchange rate of Aus $1=US $0.69 is applicable). There were no significant between-group differences in sedentary behavior minutes per day over 12 months, although the intervention group completed 22 minutes less than the control group (95% CI -22.80 to 66.69; P=.33; Cohen d=0.21). The intervention group had a lower BMI (β=1.62; P=.05), waist circumference (β=5.81; P=.01), waist-to-hip ratio (β=.03, P=.03), and quality of life (β=3.30; P=.05) than the control group. The intervention was more effective but more costly in reducing sedentary behavior (ICER Aus $351.77) and anxiety (ICER Aus $10,987.71) at 12 months. The intervention was also more effective yet costly in increasing quality of life (ICER Aus $93,395.50) at 12 months.ConclusionsThe Vire app and ToDo-CR program was not an outcome-effective or cost-effective solution to reduce all-cause hospital admissions or ED presentations in cardiac rehabilitation compared with usual care. Smartphone apps that target sedentary behavior alone may not be an effective solution for cardiac rehabilitation participants to reduce hospital admissions and sedentary behavior.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001223123; https://australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619001223123.International registered report identifier (irrid)RR2-10.1136/bmjopen-2020-040479.

Project description:BackgroundCardiac rehabilitation participants are encouraged to meet physical activity guidelines to reduce the risk of repeat cardiac events. However, previous studies have found that physical activity levels are low and sedentary behavior is high, both during and after cardiac rehabilitation. There is potential for smartphone apps to be effective in reducing sedentary behavior, although among the few studies that have investigated smartphone apps in cardiac rehabilitation, none targeted sedentary behavior.ObjectiveThis study aims to evaluate the feasibility of a behavioral smartphone app (Vire) and a web-based behavior change program (ToDo-CR) to decrease sedentary behavior in cardiac rehabilitation participants.MethodsUsing a single-center, pre-post design, participants were recruited by nursing staff on admission to cardiac rehabilitation. All eligible participants installed the Vire app, were given a Fitbit Flex, and received the 6-week ToDo-CR program while attending cardiac rehabilitation. The ToDo-CR program uses personalized analytics to interpret important behavioral aspects (physical activity, variety, and social opportunity) and real-time information for generating and suggesting context-specific actionable microbehavioral alternatives (Do's). Do's were delivered via the app, with participants receiving 14 to 19 Do's during the 6-week intervention period. Outcome measures were collected at 0, 6, and 16 weeks. The assessors were not blinded. Feasibility outcomes included recruitment and follow-up rates, resource requirements, app usability (Unified Theory of Acceptance and Use of Technology 2 [UTAUT2] questionnaire), and objectively measured daily minutes of sedentary behavior (ActiGraph) for sample size estimation. Secondary outcomes included functional aerobic capacity (6-min walk test), quality of life (MacNew Heart Disease Health-Related Quality of Life Questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale questionnaire), BMI, waist circumference, waist-to-hip ratio, and blood pressure.ResultsBetween January and May 2019, 20 participants were recruited consecutively. One-third of people who commenced cardiac rehabilitation were eligible to participate. Other than declining to take part in the study (15/40, 38%), not having a smartphone was a major reason for exclusion (11/40, 28%). Those excluded without a smartphone were significantly older than participants with a smartphone (mean difference 20 [SD 5] years; P<.001). Participants were, on average, aged 54 (SD 13) years, mostly male (17/20, 85%), and working (12/20, 67%). At 6 weeks, 95% (19/20) of participants were assessed, and 60% (12/20) of participants were assessed at 16 weeks. Participants were relatively satisfied with the usability of the app (UTAUT2 questionnaire). Overall, participants spent 11 to 12 hours per day sitting. There was a medium effect size (Cohen d=0.54) for the reduction in sedentary behavior (minutes per day) over 16 weeks.ConclusionsThe use of a behavioral smartphone app to decrease sitting time appears to be feasible in cardiac rehabilitation. A larger randomized controlled trial is warranted to determine the effectiveness of the app.

Project description:BackgroundSmartphone apps are increasingly used to deliver physical activity and sedentary behaviour interventions for people with cardiovascular disease. However, the active components of these interventions which aim to change behaviours are unclear.AimsTo identify behaviour change techniques used in smartphone app interventions for improving physical activity and sedentary behaviour in people with cardiovascular disease. Secondly, to investigate the association of the identified techniques on improving these behaviours.MethodsSix databases (Medline, CINAHL Plus, Cochrane Library, SCOPUS, Sports Discus, EMBASE) were searched from 2007 to October 2020. Eligible studies used a smartphone app intervention for people with cardiovascular disease and reported a physical activity and/or sedentary behaviour outcome. The behaviour change techniques used within the apps for physical activity and/or sedentary behaviour were coded using the Behaviour Change Technique Taxonomy (v1). The association of behaviour change techniques on physical activity outcomes were explored through meta-regression.ResultsForty behaviour change techniques were identified across the 19 included app-based interventions. Only two studies reported the behaviour change techniques used to target sedentary behaviour change. The most frequently used techniques for sedentary behaviour and physical activity were habit reversal and self-monitoring of behaviour respectively. In univariable analyses, action planning (β =0.42, 90%CrI 0.07-0.78) and graded tasks (β =0.33, 90%CrI -0.04-0.67) each had medium positive associations with increasing physical activity. Participants in interventions that used either self-monitoring outcome(s) of behaviour (i.e. outcomes other than physical activity) (β = - 0.47, 90%CrI -0.79--0.16), biofeedback (β = - 0.47, 90%CrI -0.81--0.15) and information about health consequences (β = - 0.42, 90%CrI -0.74--0.07) as behaviour change techniques, appeared to do less physical activity. In the multivariable model, these predictors were not clearly removed from zero.ConclusionThe behaviour change techniques action planning and graded tasks are good candidates for causal testing in future experimental smartphone app designs.

Project description:BackgroundSmartphone applications provide new opportunities for secondary prevention healthcare. This systematic review and meta-analysis aimed to determine if smartphone applications are effective at changing physical activity and sedentary behaviour in people with cardiovascular disease.MethodsSix electronic databases (Medline, CINAHL Plus, Cochrane Library, SCOPUS, Sports Discus and EMBASE) were searched from 2007 to October 2020. Cardiovascular disease secondary prevention physical activity or sedentary behaviour interventions were included where the primary element was a smartphone or tablet computer application (excluding SMS-only text-messaging). Study quality was assessed using validated tools appropriate for each study design. Random effects model was used and the pooled mean difference between post scores were calculated. Subgroup analyses were conducted to examine differences based on diagnosis, sample size, age, intervention duration, activity tracker use, target behaviour, and self-report versus device-measured outcome.ResultsNineteen studies with a total of 1,543 participants were included (coronary heart disease, n = 10; hypertension, n = 4; stroke, n = 3; heart failure, n = 1; peripheral artery disease, n = 1). Risk of bias was rated as high. Thirteen studies were included in the meta-analysis. Only two controlled studies reported on sedentary behaviour. Smartphone applications produced a significant increase of 40.35 minutes of moderate-to-vigorous intensity physical activity per week (7 studies; p = 0.04; 95% CI 1.03 to 79.67) and 2,390 steps per day (3 studies; p = 0.0007; 95% CI 1,006.9 to 3,791.2). Subgroup analyses found no difference when comparing diagnoses, sample size, activity tracker use, target behaviour and self-report versus device-measured outcome. Larger improvements in physical activity were noted in intervention durations of ≤3-months and participants ≥60yrs (95.35 mins.week-1; p = 0.05).ConclusionsSmartphone applications were effective in increasing physical activity in people with cardiovascular disease. Caution is warranted for the low-quality evidence, small sample and larger coronary heart disease representation. More rigorous research is needed to investigate the effect of smartphone applications across diagnoses and in sedentary behaviour.

Project description:BackgroundExercise-based cardiac rehabilitation (CR) is a crucial part of the treatment of patients with cardiac diseases, and adherence to healthy behavior is a prerequisite to improve long-term prognosis. Unfortunately, adherence to healthy behavior adapted in CR is challenging for many cardiac patients in the long term. Recently, we demonstrated that follow-up conducted via an app for 1 year significantly improved adherence to healthy behavior after CR. To increase the knowledge and understanding of mobile Health (mHealth) interventions that can promote acceptance and adherence, qualitative research investigating patients' experiences with these interventions is warranted.ObjectiveThe aim was to investigate patient experiences with individualized long-term follow-up conducted via an app for 1 year and their thoughts about what features promoted adherence to healthy behavior after CR. The purpose was to increase the understanding of significant findings previously reported and to guide future development of similar interventions in the field of adherence.MethodsA qualitative study with individual interviews was conducted from November 2018 to May 2019. A thematic interview guide was used when conducting the semistructured in-depth interviews. The interviews were audio recorded and transcribed successively during the period in which the interviews were conducted. Texts were managed and systematized by NVivo. Interviews were analyzed by qualitative content analysis. Codes and themes were inductively developed.ResultsTen patients who had participated in a randomized controlled trial evaluating the effect of follow-up conducted via an app on adherence to healthy behavior after CR were included. The median patient age was 65 years (range 46-72 years), and both genders were represented. The analysis resulted in the following 4 themes describing the patients' experiences: (1) The person behind the app is crucial for motivation and adherence; (2) The app as a commitment; (3) The app as a path to independence; and (4) Suggestions for improvements. Features experienced as beneficial to promote adherence were individualized feedback and the use of goal setting. The significance of the person behind the app (the supervisor) who provided individualized feedback was a consistent finding. This person seemed to promote motivation in general and to enable other known behavioral change techniques.ConclusionsThe person behind the app (the supervisor) seems to be one of the most significant success factors in promoting adherence to healthy behavior after CR. This indicates that a health care provider must actively participate in a patient's process of adherence to healthy behavior, even when using interventions, including an app. Future development of interventions in the field of adherence should strive to create tools that enable an ongoing collaborative relationship between the patient and the health care provider. The follow-up should be based on the patient's own goals, and individualized feedback should be provided.

Project description:BACKGROUND:Falls have implications for older adults' health and well-being. Strength and balance interventions significantly reduce the risk of falls. However, patients do not always perform the unsupervised home exercise needed for fall reduction. OBJECTIVE:This study aims to develop motivational smartphone apps co-designed with health professionals and older adults to support patients to perform exercise proven to aid fall reduction and to explore the apps' usability and acceptability with both health professionals and patients. METHODS:There were 3 phases of app development that included analysis, design, and implementation. For analysis, we examined the literature to establish key app components and had a consultation with 12 older adults attending a strength and balance class, exercise instructors, and 3 fall services. For design, we created prototype apps and conducted 2 patient and public involvement workshops, one with 5 health professionals and the second with 8 older adults from an exercise group. The apps were revised based on the feedback. For implementation, we tested them with one fall service and their patients for 3 weeks. Participatory evaluation was used through testing, semistructured interviews, and focus groups to explore acceptability and usability. Focus groups were conducted with the service that tested the apps and two other services. Qualitative data were analyzed using the framework approach. RESULTS:On the basis of findings from the literature and consultations in the analysis phase, we selected Behavior Change Techniques, such as goal setting, action planning, and feedback on behavior, to be key parts of the app. We developed goals using familiar icons for patients to select and add while self-reporting exercise and decided to develop 2 apps, one for patients (My Activity Programme) and one for health professionals (Motivate Me). This enabled health professionals to guide patients through the goal-setting process, making it more accessible to nontechnology users. Storyboards were created during the design phase, leading to prototypes of "Motivate Me" and "My Activity Programme." Key changes from the workshops included being able to add more details about the patients' exercise program and a wider selection of goals within "Motivate Me." The overall app design was acceptable to health professionals and older adults. In total, 7 patients and 3 health professionals participated in testing in the implementation phase, with interviews conducted with 6 patients and focus groups, with 3 teams (11 health professionals). Barriers, facilitators, and further functionality were identified for both apps, with 2 cross-cutting themes around phone usability and confidence. CONCLUSIONS:The motivational apps were found to be acceptable for older adults taking part in the design stage and patients and health professionals testing the apps in a clinical setting. User-led design is important to ensure that the apps are usable and acceptable.

Project description:IntroductionThe burden of cardiovascular disease (CVD) is rapidly increasing in developing countries, however access to cardiac rehabilitation and secondary prevention (CR/SP) in these countries is limited. Alternative delivery models that are low-cost and easy to access are urgently needed to address this service gap. The objective of this study is to investigate whether a smartphone and social media-based (WeChat) home CR/SP programme can facilitate risk factor monitoring and modification to improve disease self-management and health outcomes in patients with coronary heart disease (CHD), after percutaneous coronary intervention (PCI) therapy.Methods and analysisWe propose a single-blind, randomised controlled trial of 300 patients post-PCI with follow-up over 12 months. The intervention group will receive a smartphone-based and WeChat-based CR/SP programme providing education and support for risk factor monitoring and modification. SMART-CR/SP incorporates core components of modern CR/SP: physical activity tracking with interactive feedback and goal setting; education modules addressing CHD understanding and self-management; remote blood pressure monitoring and strategies to improve medication adherence. Furthermore, a dedicated data portal and a CR/SP coach will facilitate individualised supervision and counselling. The control group will receive usual care but no formal CR/SP programme. The primary outcome is change in exercise capacity measured by 6 minute walk test distance. Secondary outcomes include knowledge and awareness of CHD, risk factor status, medication adherence, psychological well-being and quality of life, major cardiovascular events, re-hospitalisations and all-cause mortality. To assess the feasibility and patients' acceptance of the intervention, a process evaluation will be performed at the conclusion of the study.Ethics and disseminationEthics approval was granted by both the Human Research Ethics Committee of Fudan University Zhongshan Hospital (HREC B2016-058) and Curtin University Human Research Ethics Office (HRE2016-0120). Results will be disseminated via peer-reviewed publications and presentations at conferences.Clinical trial registration numberChiCTR-INR-16009598; Pre-results.

Dataset Information

A smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on hospital admissions: the ToDo-CR randomised controlled trial study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

A smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on hospital admissions: the ToDo-CR randomised controlled trial study protocol.

Similar Datasets

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