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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.

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Project description:BackgroundTransformUs was a four-arm school-based intervention to increase physical activity and reduce sedentary behaviour among primary school children. Pedagogical and environmental strategies targeted the classroom, school grounds and family setting. The aims of this study were to evaluate program fidelity, dose, appropriateness, satisfaction and sustainability, and associations between implementation level and outcomes among the three intervention arms.MethodsAt baseline, 18-months (mid-intervention) and 30-months (post-intervention), teachers, parents and children completed surveys, and children wore GT3X ActiGraph accelerometers for 8 days at each time point to determine physical activity and sedentary time. Implementation data were pooled across the three intervention groups and teachers were categorised by level of implementation: (i) 'Low' (< 33% delivered); (ii) 'Moderate' (33-67% delivered); and (iii) 'High' (> 67% delivered). Linear and logistic mixed models examined between group differences in implementation, and the association with children's physical activity and sedentary time outcomes. Qualitative survey data were analysed thematically.ResultsAmong intervention recipients, 52% (n = 85) of teachers, 29% (n = 331) of parents and 92% (n = 407) of children completed baseline evaluation surveys. At 18-months, teachers delivered on average 70% of the key messages, 65% set active/standing homework, 30% reported delivering > 1 standing lesson/day, and 56% delivered active breaks per day. The majority of teachers (96%) made activity/sports equipment available during recess and lunch, and also used this equipment in class (81%). Fidelity and dose of key messages and active homework reduced over time, whilst fidelity of standing lessons, active breaks and equipment use increased. TransformUs was deemed appropriate for the school setting and positively received. Implementation level and child behavioural outcomes were not associated. Integration of TransformUs into existing practices, children's enjoyment, and teachers' awareness of program benefits all facilitated delivery and sustainability.ConclusionsThis study demonstrated that intervention dose and fidelity increased over time, and that children's enjoyment, senior school leadership and effective integration of interventions into school practices facilitated improved intervention delivery and sustainability. Teacher implementation level and child behavioural outcomes were unrelated, suggesting intervention efficacy was achieved irrespective of implementation variability. The potential translatability of TransformUs into practice contexts may therefore be increased. Findings have informed scale-up of TransformUs across Victoria, Australia.Trial registrationInternational Standard Randomized Controlled Trial Number ISRCTN83725066; Australian New Zealand Clinical Trials Registry Number ACTRN12609000715279. Registered 19 August 2009. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=308387&isReview=true.

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).

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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).

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