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Personalised eHealth intervention to increase physical activity and reduce sedentary behaviour in rehabilitation after cardiac operations: study protocol for the PACO randomised controlled trial (NCT03470246).

ABSTRACT: Introduction:Personalized intervention to increase physical Activity and reduce sedentary behaviour in rehabilitation after Cardiac Operations (PACO) is a smartphone-based and accelerometer-based eHealth intervention to increase physical activity (PA) and reduce sedentary behaviour (SB) among patients recovering from cardiac surgery. Design:Prospective randomised controlled trial. Methods and analysis:The present protocol describes a randomised controlled clinical trial to be conducted in the Heart Centres of Kuopio and Turku university hospitals. The trial comprises 540 patients scheduled for elective coronary artery bypass grafting, aortic valve replacement or mitral valve repair. The patients will be randomised into two groups. The control group will receive standard postsurgical rehabilitation guidance. The eHealth intervention group will be given the same guidance together with personalised PA guidance during 90 days after discharge. These patients will receive personalised daily goals to increase PA and reduce SB via the ExSedapplication. Triaxial accelerometers will be exploited to record patients' daily accumulated PA and SB, and transmit them to the application. Using the accelerometer data, the application will provide online guidance to the patients and feedback of accomplishing their activity goals. The data will also be transmitted to the cloud, where a physiotherapist can monitor individual activity profiles and customise the subsequent PA and SB goals online. The postoperative improvement in patients' step count, PA, exercise capacity, quality of sleep, laboratory markers, transthoracic echocardiography (TTE) parameters and quality of life, and reduction in SB and incidence of major cardiac events are investigated as outcomes. Conclusions:The PACO intervention aims to build a personalised eHealth tool for the online tutoring of cardiac surgery patients. Trial registration number:NCT03470246.

SUBMITTER: Vasankari V

PROVIDER: S-EPMC6615853 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Personalised eHealth intervention to increase physical activity and reduce sedentary behaviour in rehabilitation after cardiac operations: study protocol for the PACO randomised controlled trial (NCT03470246).

Vasankari Ville V Halonen Jari J Husu Pauliina P Vähä-Ypyä Henri H Tokola Kari K Suni Jaana J Sievänen Harri H Anttila Vesa V Airaksinen Juhani J Vasankari Tommi T Hartikainen Juha J

BMJ open sport & exercise medicine 20190705 1

<h4>Introduction</h4>Personalized intervention to increase physical Activity and reduce sedentary behaviour in rehabilitation after Cardiac Operations (PACO) is a smartphone-based and accelerometer-based eHealth intervention to increase physical activity (PA) and reduce sedentary behaviour (SB) among patients recovering from cardiac surgery.<h4>Design</h4>Prospective randomised controlled trial.<h4>Methods and analysis</h4>The present protocol describes a randomised controlled clinical trial to ...[more]

PMID: 31354960

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Project description:BackgroundIncentive-based programs represent a promising approach for health insurers to encourage health-promoting behaviours. However, little is known about the value for money of such programs. This study aimed to determine the cost-effectiveness of the ACHIEVE (Active CHoices IncEntiVE) program designed to incentivise increased physical activity and reduced sedentary behaviour in middle-aged adults.Methods A within-trial cost-efficacy analysis was conducted. Benefits were assessed by evaluating paired t-tests from participants' pre- and post- trial Body Mass Index (BMI) (kg/m2), sitting time (minutes/day) and metabolic equivalents (METS) minutes. A health sector perspective was adopted for the assessment of costs. Pathway analysis was used to determine the resource use associated with the intervention, with costs expressed in Australian dollars (A$) for the 2015 reference year. A long-term cost-effectiveness analysis was undertaken which extended the analysis time horizon and the trial population to the relevant eligible Australian population. Within this analysis, the 16-week intervention was modelled for roll-out across Australia over a 1-year time horizon targeting people with private health insurance who are insufficiently active and highly sedentary. Improved health related quality of life quantified in Health-Adjusted Life Years (HALYs) (based on the health impacts of increased metabolic equivalent (MET) minutes and reduced body mass index (BMI) and cost-offsets (resulting from reductions in obesity and physical inactivity-related diseases) were tracked until the cohort reached age 100 years or death. A 3% discount rate was used and all outcomes were expressed in 2010 values. Simulation modelling techniques were used to present 95% uncertainty intervals around all outputs.Results The within-trial cost-efficacy analysis indicated that the ACHIEVE intervention cost approximately A$77,432. The cost per participant recruited was A$944. The incremental cost-effectiveness ratio (ICER) for MET increase per person per week was A$0.61; minute of sedentary time reduced per participant per day was A$5.15 and BMI unit loss per participant was A$763. The long-term cost effectiveness analysis indicated that if the intervention was scaled-up to all eligible Australians, approximately 265,095 participants would be recruited to the program at an intervention cost of A$107.4 million. Health care cost savings were A$33.4 million. Total HALYs gained were 2,709. The mean ICER was estimated at A$27,297 per HALY gained which is considered cost-effective in the Australian setting.Conclusion The study findings suggest that financial incentives to promote physical activity and reduce sedentary behaviour are likely to be cost-effective.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12616000158460 (10/02/2016).

Project description:BackgroundOffice work generally consists of high amounts of sedentary behaviour (SB) which has been associated with negative health consequences. We developed the "WorktivIty" mobile app to help office workers reduce their SB through self-monitoring and feedback on sedentary time, prompts to break sedentary time, and educational facts. The aim of this paper is to report the feasibility of delivering the Worktivity intervention to desk-based office workers in the workplace setting and describe methodological considerations for a future trial.MethodsWe conducted a three-arm feasibility cluster randomised controlled pilot study over an 8-week period with full time-desk based employees. Clustered randomisation was to one of three groups: Worktivity mobile app (MA; n = 20), Worktivity mobile app plus SSWD (MA+SSWD; n = 20), or Control (C; n = 16). Feasibility was assessed using measures of recruitment and retention, intervention engagement, intervention delivery, completion rates and usable data, adverse events, and acceptability.ResultsRecruitment of companies to participate in this study was challenging (8% of those contacted), but retention of individual participants within the recruited groups was high (81% C, 90% MA + SSWD, 95% MA). Office workers' engagement with the app was moderate (on average 59%). Intervention delivery was partially compromised due to diminishing user engagement and technical issues related to educational fact delivery. Sufficient amounts of useable data were collected, however either missing or unusable data were observed with activPAL™, with data loss increasing at each follow up time point. No serious adverse events were identified during the study. The majority of participants agreed that the intervention could be implemented within the workplace setting (65% MA; 72% MA + SSWD) but overall satisfaction with the intervention was modest (58% MA; 39% MA + SSWD).ConclusionsThe findings suggest that, in principle, it is feasible to implement a mobile app-based intervention in the workplace setting however the Worktivity intervention requires further technical refinements before moving to effectiveness trials. Challenges relating to the initial recruitment of workplaces and maintaining user engagement with the mHealth intervention over time need to be addressed prior to future large-scale implementation. Further research is needed to identify how best to overcome these challenges.

Project description:Background People with severe mental illness (SMI) are less physically active and more sedentary than healthy controls, contributing to poorer physical health outcomes in this population. There is a need to understand the feasibility and acceptability, and explore the effective components, of health behaviour change interventions targeting physical activity and sedentary behaviour in this population in rural and semi-rural settings. Methods This 13-week randomised controlled feasibility trial compares the Walking fOR Health (WORtH) multi-component behaviour change intervention, which includes education, goal-setting and self-monitoring, with a one-off education session. It aims to recruit 60 inactive adults with SMI via three community mental health teams in Ireland and Northern Ireland. Primary outcomes are related to feasibility and acceptability, including recruitment, retention and adherence rates, adverse events and qualitative feedback from participants and clinicians. Secondary outcome measures include self-reported and accelerometer-measured physical activity and sedentary behaviour, anthropometry measures, physical function and mental wellbeing. A mixed-methods process evaluation will be undertaken. This study protocol outlines changes to the study in response to the COVID-19 pandemic. Discussion This study will address the challenges and implications of remote delivery of the WORtH intervention due to the COVID-19 pandemic and inform the design of a future definitive randomised controlled trial if it is shown to be feasible. Trial registration The trial was registered on clinicaltrials.gov (NCT04134871) on 22 October 2019. Background People with severe mental illness (SMI) are less physically active and more sedentary than healthy controls, contributing to poorer physical health outcomes in this population. There is a need to understand the feasibility and acceptability, and explore the effective components, of health behaviour change interventions targeting physical activity and sedentary behaviour in this population in rural and semi-rural settings. Methods This 13-week randomised controlled feasibility trial compares the Walking fOR Health (WORtH) multi-component behaviour change intervention, which includes education, goal-setting and self-monitoring, with a one-off education session. It aims to recruit 60 inactive adults with SMI via three community mental health teams in Ireland and Northern Ireland. Primary outcomes are related to feasibility and acceptability, including recruitment, retention and adherence rates, adverse events and qualitative feedback from participants and clinicians. Secondary outcome measures include self-reported and accelerometer-measured physical activity and sedentary behaviour, anthropometry measures, physical function and mental wellbeing. A mixed-methods process evaluation will be undertaken. This study protocol outlines changes to the study in response to the COVID-19 pandemic. Discussion This study will address the challenges and implications of remote delivery of the WORtH intervention due to the COVID-19 pandemic and inform the design of a future definitive randomised controlled trial if it is shown to be feasible. Trial registration The trial was registered on clinicaltrials.gov (NCT04134871) on 22 October 2019.

Project description:BackgroundSedentary behaviour is any waking behaviour characterised by an energy expenditure of ≤1.5 metabolic equivalent of task while in a sitting or reclining posture. Prolonged bouts of sedentary behaviour have been associated with negative health outcomes in all age groups. We examined qualitative research investigating perceptions and experiences of sedentary behaviour and of participation in non-workplace interventions designed to reduce sedentary behaviour in adult populations.MethodA systematic search of seven databases (MEDLINE, AMED, Cochrane, PsychINFO, SPORTDiscus, CINAHL and Web of Science) was conducted in September 2017. Studies were assessed for methodological quality and a thematic synthesis was conducted. Prospero database ID: CRD42017083436.ResultsThirty individual studies capturing the experiences of 918 individuals were included. Eleven studies examined experiences and/or perceptions of sedentary behaviour in older adults (typically ≥60 years); ten studies focused on sedentary behaviour in people experiencing a clinical condition, four explored influences on sedentary behaviour in adults living in socio-economically disadvantaged communities, two examined university students' experiences of sedentary behaviour, two on those of working-age adults, and one focused on cultural influences on sedentary behaviour. Three analytical themes were identified: 1) the impact of different life stages on sedentary behaviour 2) lifestyle factors influencing sedentary behaviour and 3) barriers and facilitators to changing sedentary behaviour.ConclusionsSedentary behaviour is multifaceted and influenced by a complex interaction between individual, environmental and socio-cultural factors. Micro and macro pressures are experienced at different life stages and in the context of illness; these shape individuals' beliefs and behaviour related to sedentariness. Knowledge of sedentary behaviour and the associated health consequences appears limited in adult populations, therefore there is a need for provision of accessible information about ways in which sedentary behaviour reduction can be integrated in people's daily lives. Interventions targeting a reduction in sedentary behaviour need to consider the multiple influences on sedentariness when designing and implementing interventions.

Project description:ObjectivesTo test the efficacy of a multicomponent technology intervention for reducing daily sedentary time and improving cardiometabolic disease risk among sedentary, overweight university employees.DesignBlinded, randomised controlled trial.SettingA large south-eastern university in the USA.Participants49 middle-aged, primarily female, sedentary and overweight adults working in sedentary jobs enrolled in the study. A total of 40 participants completed the study.InterventionsParticipants were randomised to either: (1) an intervention group (N=23; 47.6+9.9 years; 94.1% female; 33.2+4.5 kg/m(2)); (2) or wait-list control group (N=17; 42.6+8.9 years; 86.9% female; 31.7+4.9 kg/m(2)). The intervention group received a theory-based, internet-delivered programme, a portable pedal machine at work and a pedometer for 12 weeks. The wait-list control group maintained their behaviours for 12 weeks.Outcome measuresPrimary (sedentary and physical activity behaviour measured objectively through StepWatch) and secondary (heart rate, blood pressure, height, weight, waist circumference, per cent body fat, cardiorespiratory fitness, fasting lipids) outcomes were measured at baseline and postintervention (12 weeks). Exploratory outcomes including intervention compliance and process evaluation measures were also assessed postintervention.ResultsCompared to controls, the intervention group reduced daily sedentary time (mean change (95%CI): -58.7 min/day (-118.4 to 0.99; p<0.01)) after adjusting for baseline values and monitor wear time. Intervention participants logged on to the website 71.3% of all intervention days, used the pedal machine 37.7% of all working intervention days and pedalled an average of 31.1 min/day.ConclusionsThese findings suggest that the intervention was engaging and resulted in reductions in daily sedentary time among full-time sedentary employees. These findings hold public health significance due to the growing number of sedentary jobs and the potential of these technologies in large-scale worksite programmes.Trial registrationClinicalTrials.gov #NCT01371084.

Project description:BackgroundThe growing number of patients with type 2 diabetes and prediabetes is a major public health concern. Physical activity is a cornerstone of diabetes management and may prevent its onset in prediabetes patients. Despite this, many patients with (pre)diabetes remain physically inactive. Primary care physicians are well-situated to deliver interventions to increase their patients' physical activity levels. However, effective and sustainable physical activity interventions for (pre)diabetes patients that can be translated into routine primary care are lacking.MethodsWe describe the rationale and protocol for a 12-month pragmatic, multicentre, randomised, controlled trial assessing the effectiveness of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED). Twenty-one general practices will recruit 340 patients with (pre)diabetes during routine health check-ups. Patients allocated to the active control arm will receive a Fitbit activity tracker to self-monitor their daily steps and try to achieve the recommended step goal. Patients allocated to the intervention arm will additionally receive the mHealth intervention, including the delivery of several text messages per week, with some of them delivered just in time, based on data continuously collected by the Fitbit tracker. The trial consists of two phases, each lasting six months: the lead-in phase, when the mHealth intervention will be supported with human phone counselling, and the maintenance phase, when the intervention will be fully automated. The primary outcome, average ambulatory activity (steps/day) measured by a wrist-worn accelerometer, will be assessed at the end of the maintenance phase at 12 months.DiscussionThe trial has several strengths, such as the choice of active control to isolate the net effect of the intervention beyond simple self-monitoring with an activity tracker, broad eligibility criteria allowing for the inclusion of patients without a smartphone, procedures to minimise selection bias, and involvement of a relatively large number of general practices. These design choices contribute to the trial's pragmatic character and ensure that the intervention, if effective, can be translated into routine primary care practice, allowing important public health benefits.Trial registrationClinicalTrials.gov (NCT05351359, 28/04/2022).

Project description:IntroductionCardiac 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 analysisA 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 disseminationThis 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 numberACTRN12619001223123.

Dataset Information

Personalised eHealth intervention to increase physical activity and reduce sedentary behaviour in rehabilitation after cardiac operations: study protocol for the PACO randomised controlled trial (NCT03470246).

Publications

Personalised eHealth intervention to increase physical activity and reduce sedentary behaviour in rehabilitation after cardiac operations: study protocol for the PACO randomised controlled trial (NCT03470246).

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