Assessing the Effect of Data Quality on Distance Estimation in Smartphone-Based Outdoor 6MWT.

As a result of technological advancements, functional capacity assessments, such as the 6-minute walk test, can be performed remotely, at home and in the community. Current studies, however, tend to overlook the crucial aspect of data quality, often limiting their focus to idealised scenarios. Challenging conditions may arise when performing a test given the risk of collecting poor-quality GNSS signal, which can undermine the reliability of the results. This work shows the impact of applying filtering rules to avoid noisy samples in common algorithms that compute the walked distance from positioning data. Then, based on signal features, we assess the reliability of the distance estimation using logistic regression from the following two perspectives: error-based analysis, which relates to the estimated distance error, and user-based analysis, which distinguishes conventional from unconventional tests based on users' previous annotations. We highlight the impact of features associated with walked path irregularity and direction changes to establish data quality. We evaluate features within a binary classification task and reach an F1-score of 0.93 and an area under the curve of 0.97 for the user-based classification. Identifying unreliable tests is helpful to clinicians, who receive the recorded test results accompanied by quality assessments, and to patients, who can be given the opportunity to repeat tests classified as not following the instructions.

Quantifying Parkinson's disease severity using mobile wearable devices and machine learning: the ParkApp pilot study protocol.

INTRODUCTION: The clinical assessment of Parkinson's disease (PD) symptoms can present reliability issues and, with visits typically spaced apart 6 months, can hardly capture their frequent variability. Smartphones and smartwatches along with signal processing and machine learning can facilitate frequent, remote, reliable and objective assessments of PD from patients' homes. AIM: To investigate the feasibility, compliance and user experience of passively and actively measuring symptoms from home environments using data from sensors embedded in smartphones and a wrist-wearable device. METHODS AND ANALYSIS: In an ongoing clinical feasibility study, participants with a confirmed PD diagnosis are being recruited. Participants perform activity tests, including Timed Up and Go (TUG), tremor, finger tapping, drawing and vocalisation, once a week for 2 months using the Mobistudy smartphone app in their homes. Concurrently, participants wear the GENEActiv wrist device for 28 days to measure actigraphy continuously. In addition to using sensors, participants complete the Beck's Depression Inventory, Non-Motor Symptoms Questionnaire (NMSQuest) and Parkinson's Disease Questionnaire (PDQ-8) questionnaires at baseline, at 1 month and at the end of the study. Sleep disorders are assessed through the Parkinson's Disease Sleep Scale-2 questionnaire (weekly) and a custom sleep quality daily questionnaire. User experience questionnaires, Technology Acceptance Model and User Version of the Mobile Application Rating Scale, are delivered at 1 month. Clinical assessment (Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS)) is performed at enrollment and the 2-month follow-up visit. During visits, a TUG test is performed using the smartphone and the G-Walk motion sensor as reference device. Signal processing and machine learning techniques will be employed to analyse the data collected from Mobistudy app and the GENEActiv and correlate them with the MDS-UPDRS. Compliance and user aspects will be informing the long-term feasibility. ETHICS AND DISSEMINATION: The study received ethical approval by the Swedish Ethical Review Authority (Etikprövningsmyndigheten), with application number 2022-02885-01. Results will be reported in peer-reviewed journals and conferences. Results will be shared with the study participants.

Home monitoring with connected mobile devices for asthma attack prediction with machine learning.

Monitoring asthma is essential for self-management. However, traditional monitoring methods require high levels of active engagement, and some patients may find this tedious. Passive monitoring with mobile-health devices, especially when combined with machine-learning, provides an avenue to reduce management burden. Data for developing machine-learning algorithms are scarce, and gathering new data is expensive. A few datasets, such as the Asthma Mobile Health Study, are publicly available, but they only consist of self-reported diaries and lack any objective and passively collected data. To fill this gap, we carried out a 2-phase, 7-month AAMOS-00 observational study to monitor asthma using three smart-monitoring devices (smart-peak-flow-meter/smart-inhaler/smartwatch), and daily symptom questionnaires. Combined with localised weather, pollen, and air-quality reports, we collected a rich longitudinal dataset to explore the feasibility of passive monitoring and asthma attack prediction. This valuable anonymised dataset for phase-2 of the study (device monitoring) has been made publicly available. Between June-2021 and June-2022, in the midst of UK's COVID-19 lockdowns, 22 participants across the UK provided 2,054 unique patient-days of data.

Predicting asthma attacks using connected mobile devices and machine learning: the AAMOS-00 observational study protocol.

INTRODUCTION: Supported self-management empowering people with asthma to detect early deterioration and take timely action reduces the risk of asthma attacks. Smartphones and smart monitoring devices coupled with machine learning could enhance self-management by predicting asthma attacks and providing tailored feedback.We aim to develop and assess the feasibility of an asthma attack predictor system based on data collected from a range of smart devices. METHODS AND ANALYSIS: A two-phase, 7-month observational study to collect data about asthma status using three smart monitoring devices, and daily symptom questionnaires. We will recruit up to 100 people via social media and from a severe asthma clinic, who are at risk of attacks and who use a pressurised metered dose relief inhaler (that fits the smart inhaler device).Following a preliminary month of daily symptom questionnaires, 30 participants able to comply with regular monitoring will complete 6 months of using smart devices (smart peak flow meter, smart inhaler and smartwatch) and daily questionnaires to monitor asthma status. The feasibility of this monitoring will be measured by the percentage of task completion. The occurrence of asthma attacks (definition: American Thoracic Society/European Respiratory Society Task Force 2009) will be detected by self-reported use (or increased use) of oral corticosteroids. Monitoring data will be analysed to identify predictors of asthma attacks. At the end of the monitoring, we will assess users' perspectives on acceptability and utility of the system with an exit questionnaire. ETHICS AND DISSEMINATION: Ethics approval was provided by the East of England - Cambridge Central Research Ethics Committee. IRAS project ID: 285 505 with governance approval from ACCORD (Academic and Clinical Central Office for Research and Development), project number: AC20145. The study sponsor is ACCORD, the University of Edinburgh.Results will be reported through peer-reviewed publications, abstracts and conference posters. Public dissemination will be centred around blogs and social media from the Asthma UK network and shared with study participants.

An Intuitive Risk Communication Tool to Enhance Patient-Provider Partnership in Diabetes Consultation.

INTRODUCTION: This technology report introduces an innovative risk communication tool developed to support providers in communicating diabetes-related risks more intuitively to people with type 2 diabetes mellitus (T2DM). METHODS: The development process involved three main steps: (1) selecting the content and format of the risk message; (2) developing a digital interface; and (3) assessing the usability and usefulness of the tool with clinicians through validated questionnaires. RESULTS: The tool calculates personalized risk information based on a validated simulation model (United Kingdom Prospective Diabetes Study Outcomes Model 2) and delivers it using more intuitive risk formats, such as "effective heart age" to convey cardiovascular risks. Clinicians reported high scores for the usability and usefulness of the tool, making its adoption in routine care promising. CONCLUSIONS: Despite increased use of risk calculators in clinical care, this is the first time that such a tool has been developed in the diabetes area. Further studies are needed to confirm the benefits of using this tool on behavioral and health outcomes in T2DM populations.

App-Based Versus Standard Six-Minute Walk Test in Pulmonary Hypertension: Mixed Methods Study.

BACKGROUND: Pulmonary arterial hypertension (PAH) is a chronic disease of the pulmonary vasculature that can lead to heart failure and premature death. Assessment of patients with PAH includes performing a 6-minute walk test (6MWT) in clinics. We developed a smartphone app to compute the walked distance (6MWD) indoors, by counting U-turns, and outdoors, by using satellite positioning. OBJECTIVE: The goal of the research was to assess (1) accuracy of the indoor 6MWTs in clinical settings, (2) validity and test-retest reliability of outdoor 6MWTs in the community, (3) compliance, usability, and acceptance of the app, and (4) feasibility of pulse oximetry during 6MWTs. METHODS: We tested the app on 30 PAH patients over 6 months. Patients were asked to perform 3 conventional 6MWTs in clinic while using the app in the indoor mode and one or more app-based 6MWTs in outdoor mode in the community per month. RESULTS: Bland-Altman analysis of 70 pairs of conventional versus app-based indoor 6MWDs suggests that the app is sometimes inaccurate (14.6 m mean difference, lower and upper limit of agreement: -133.35 m to 162.55 m). The comparison of 69 pairs of conventional 6MWDs and community-based outdoor 6MWDs within 7 days shows that community tests are strongly related to those performed in clinic (correlation 0.89), but the interpretation of the distance should consider that differences above the clinically significant threshold are not uncommon. Analysis of 89 pairs of outdoor tests performed by the same patient within 7 days shows that community-based tests are repeatable (intraclass correlation 0.91, standard error of measurement 36.97 m, mean coefficient of variation 12.45%). Questionnaires and semistructured interviews indicate that the app is usable and well accepted, but motivation to use it could be affected if the data are not used for clinical decision, which may explain low compliance in 52% of our cohort. Analysis of pulse oximetry data indicates that conventional pulse oximeters are unreliable if used during a walk. CONCLUSIONS: App-based outdoor 6MWTs in community settings are valid, repeatable, and well accepted by patients. More studies would be needed to assess the benefits of using the app in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT04633538; https://clinicaltrials.gov/ct2/show/NCT04633538.

OxCOVID19 Database, a multimodal data repository for better understanding the global impact of COVID-19.

Oxford COVID-19 Database (OxCOVID19 Database) is a comprehensive source of information related to the COVID-19 pandemic. This relational database contains time-series data on epidemiology, government responses, mobility, weather and more across time and space for all countries at the national level, and for more than 50 countries at the regional level. It is curated from a variety of (wherever available) official sources. Its purpose is to facilitate the analysis of the spread of SARS-CoV-2 virus and to assess the effects of non-pharmaceutical interventions to reduce the impact of the pandemic. Our database is a freely available, daily updated tool that provides unified and granular information across geographical regions. Design type Data integration objective Measurement(s) Coronavirus infectious disease, viral epidemiology Technology type(s) Digital curation Factor types(s) Sample characteristic(s) Homo sapiens.

Postpartum-Specific Vital Sign Reference Ranges.

OBJECTIVE: To estimate normal ranges for postpartum maternal vital signs. METHODS: We conducted a multicenter prospective longitudinal cohort study in the United Kingdom. We recruited women before 20 weeks of gestation without significant comorbidities and with accurately dated singleton pregnancies. Women recorded their own blood pressure, heart rate, oxygen saturation and temperature daily for 2 weeks postpartum. Trained midwives measured participants' vital signs including respiratory rate around postpartum days 1, 7, and 14. RESULTS: From August 2012 to September 2016, we screened 4,279 pregnant women; 1,054 met eligibility criteria and chose to take part. Postpartum vital sign data were available for 909 women (86.2%). Median, or 50th centile (3rd-97th centile), systolic and diastolic blood pressures increased from the day of birth: 116 mm Hg (88-147) and 74 mm Hg (59-93) to a maximum median of 121 mm Hg (102-143) and 79 mm Hg (63-94) on days 5 and 6 postpartum, respectively, an increase of 5 mm Hg (95% CI 3-7) and 5 mm Hg (95% CI 4-6), respectively. Median (3rd-97th centile) systolic and diastolic blood pressure returned to 116 mm Hg (98-137) and 75 mm Hg (61-91) by day 14 postpartum. The median (3rd-97th centile) heart rate was highest on the day of birth, 84 beats per minute (bpm) (59-110) decreasing to a minimum of 75 bpm (55-101) 14 days postpartum. Oxygen saturation, respiratory rate, and temperature did not change in the 2 weeks postbirth. Median (3rd-97th centile) day-of-birth oxygen saturation was 96% (93-98). Median (3rd-97th centile) day-of-birth respiratory rate was 15 breaths per minute (10-22). Median (3rd-97th centile) day-of-birth temperature was 36.7°C (35.6-37.6). CONCLUSION: We present widely relevant, postpartum, day-specific reference ranges which may facilitate early detection of abnormal blood pressure, heart rate, respiratory rate, oxygen saturation and temperature during the puerperium. Our findings could inform construction of an evidence-based modified obstetric early warning system to better identify unwell postpartum women. CLINICAL TRIAL REGISTRATION: ISRCTN, 10838017.

Privacy Personas for IoT-Based Health Research: A Privacy Calculus Approach.

The reliance on data donation from citizens as a driver for research, known as citizen science, has accelerated during the Sars-Cov-2 pandemic. An important enabler of this is Internet of Things (IoT) devices, such as mobile phones and wearable devices, that allow continuous data collection and convenient sharing. However, potentially sensitive health data raises privacy and security concerns for citizens, which research institutions and industries must consider. In e-commerce or social network studies of citizen science, a privacy calculus related to user perceptions is commonly developed, capturing the information disclosure intent of the participants. In this study, we develop a privacy calculus model adapted for IoT-based health research using citizen science for user engagement and data collection. Based on an online survey with 85 participants, we make use of the privacy calculus to analyse the respondents' perceptions. The emerging privacy personas are clustered and compared with previous research, resulting in three distinct personas which can be used by designers and technologists who are responsible for developing suitable forms of data collection. These are the 1) Citizen Science Optimist, the 2) Selective Data Donor, and the 3) Health Data Controller. Together with our privacy calculus for citizen science based digital health research, the three privacy personas are the main contributions of this study.

Gestation-Specific Vital Sign Reference Ranges in Pregnancy.

OBJECTIVE: To estimate normal ranges for maternal vital signs throughout pregnancy, which have not been well defined in a large contemporary population. METHODS: We conducted a three-center, prospective, longitudinal cohort study in the United Kingdom from August 2012 to September 2017. We recruited women at less than 20 weeks of gestation without significant comorbidities with accurately dated singleton pregnancies. We measured participants' blood pressure (BP), heart rate, respiratory rate, oxygen saturation and temperature following standardized operating procedures at 4-6 weekly intervals throughout pregnancy. RESULTS: We screened 4,279 pregnant women, 1,041 met eligibility criteria and chose to take part. Systolic and diastolic BP decreased slightly from 12 weeks of gestation: median or 50th centile (3rd-97th centile) 114 (95-138); 70 (56-87) mm Hg to reach minimums of 113 (95-136); 69 (55-86) mm Hg at 18.6 and 19.2 weeks of gestation, respectively, a change (95% CI) of -1.0 (-2 to 0); -1 (-2 to -1) mm Hg. Systolic and diastolic BP then rose to a maximum median (3rd-97th centile) of 121 (102-144); 78 (62-95) mm Hg at 40 weeks of gestation, a difference (95% CI) of 7 (6-9) and9 (8-10) mm Hg, respectively. The median (3rd-97th centile) heart rate was lowest at 12 weeks of gestation: 82 (63-105) beats per minute (bpm), rising progressively to a maximum of 91 (68-115) bpm at 34.1 weeks. SpO2 decreased from 12 weeks of gestation: median (3-97 centile) 98% (94-99%) to 97% (93-99%) at 40 weeks. The median (3-97 centile) respiratory rate at 12 weeks of gestation was 15 (9-22), which did not change with gestation. The median (3-97 centile) temperature at 12 weeks of gestation was 36.7 (35.6-37.5)°C, decreasing to a minimum of 36.5 (35.3-37.3)°C at 33.4 weeks. CONCLUSION: We present widely relevant, gestation-specific reference ranges for detecting abnormal BP, heart rate, respiratory rate, oxygen saturation and temperature during pregnancy. Our findings refute the existence of a clinically significant BP drop from 12 weeks of gestation. CLINICAL TRIAL REGISTRATION: ISRCTN, ISRCTN10838017.

The Mobile-Based 6-Minute Walk Test: Usability Study and Algorithm Development and Validation.

BACKGROUND: The 6-min walk test (6MWT) is a convenient method for assessing functional capacity in patients with cardiopulmonary conditions. It is usually performed in the context of a hospital clinic and thus requires the involvement of hospital staff and facilities, with their associated costs. OBJECTIVE: This study aimed to develop a mobile phone-based system that allows patients to perform the 6MWT in the community. METHODS: We developed 2 algorithms to compute the distance walked during a 6MWT using sensors embedded in a mobile phone. One algorithm makes use of the global positioning system to track the location of the phone when outdoors and hence computes the distance travelled. The other algorithm is meant to be used indoors and exploits the inertial sensors built into the phone to detect U-turns when patients walk back and forth along a corridor of fixed length. We included these algorithms in a mobile phone app, integrated with wireless pulse oximeters and a back-end server. We performed Bland-Altman analysis of the difference between the distances estimated by the phone and by a reference trundle wheel on 49 indoor tests and 30 outdoor tests, with 11 different mobile phones (both Apple iOS and Google Android operating systems). We also assessed usability aspects related to the app in a discussion group with patients and clinicians using a technology acceptance model to guide discussion. RESULTS: The mean difference between the mobile phone-estimated distances and the reference values was -2.013 m (SD 7.84 m) for the indoor algorithm and -0.80 m (SD 18.56 m) for the outdoor algorithm. The absolute maximum difference was, in both cases, below the clinically significant threshold. A total of 2 pulmonary hypertension patients, 1 cardiologist, 2 physiologists, and 1 nurse took part in the discussion group, where issues arising from the use of the 6MWT in hospital were identified. The app was demonstrated to be usable, and the 2 patients were keen to use it in the long term. CONCLUSIONS: The system described in this paper allows patients to perform the 6MWT at a place of their convenience. In addition, the use of pulse oximetry allows more information to be generated about the patient's health status and, possibly, be more relevant to the real-life impact of their condition. Preliminary assessment has shown that the developed 6MWT app is highly accurate and well accepted by its users. Further tests are needed to assess its clinical value.

Physical activity, sleep and cardiovascular health data for 50,000 individuals from the MyHeart Counts Study.

Studies have established the importance of physical activity and fitness for long-term cardiovascular health, yet limited data exist on the association between objective, real-world large-scale physical activity patterns, fitness, sleep, and cardiovascular health primarily due to difficulties in collecting such datasets. We present data from the MyHeart Counts Cardiovascular Health Study, wherein participants contributed data via an iPhone application built using Apple's ResearchKit framework and consented to make this data available freely for further research applications. In this smartphone-based study of cardiovascular health, participants recorded daily physical activity, completed health questionnaires, and performed a 6-minute walk fitness test. Data from English-speaking participants aged 18 years or older with a US-registered iPhone who agreed to share their data broadly and who enrolled between the study's launch and the time of the data freeze for this data release (March 10 2015-October 28 2015) are now available for further research. It is anticipated that releasing this large-scale collection of real-world physical activity, fitness, sleep, and cardiovascular health data will enable the research community to work collaboratively towards improving our understanding of the relationship between cardiovascular indicators, lifestyle, and overall health, as well as inform mobile health research best practices.

An Optimised Algorithm for Accurate Steps Counting From Smart-Phone Accelerometry.

Step counting from smart-phones allows a wide range of applications related to fitness and health. Estimating steps from phones' accelerometers is challenging because of the multitude of ways a smart-phone can be carried. We focus our work on the windowed peak detection algorithm, which has previously been shown to be accurate and efficient and thus suitable for mobile devices. We explore and optimise further the algorithm and its parameters making use of data collected by three volunteers holding the phone in six different positions. In order to simplify the analysis of the data, we also built a novel device for the detection of the ground truth steps. Over the collected data set, the algorithm reaches 95% average accuracy. We implemented the algorithm for the Android OS and released it as an open source project. A separate dataset was collected with the algorithm running on the smart-phone for further validation. The validation confirms the accuracy of the algorithm in real-time conditions.

Physical Activity and Sleep Analysis of Heart Failure Patients using Multi-sensor Patches.

Traditional heart failure markers fail to reliably predict heart-failure related hospitalisations and deaths. Multi- sensor patch data can provide an objective insight into activity and sleep patterns of patients and may therefore improve the performance of current risk-quantification algorithms. This work aimed to establish the feasibility of collecting multi-sensor patch data from heart failure patients and to perform an initial analysis of activity and sleep patterns of heart failure patients in relation to disease severity. 13 heart failure patients from the SUPPORT-HF study were provided with chest-worn multisensor patches and asked to wear the devices continuously for up to seven consecutive days. Using a combination of impedance, heart rate and accelerometer data participants' sleep and wakefulness information were extracted and analyzed in relation to self-reported symptom scores. Patch data for eleven patients were of high enough quality to be included in the analysis, accounting for 63 patient days worth of data. The heart failure patients slept for an average of 8.3 hours a night and experienced 2.8 sleep interruptions. Potential differences in sleep angle, heart rate and wake-time activity were found for patients with different heart failure severity. Larger studies are necessary to create a more coherent picture of the potential of activity and sleep as a markers for heart failure deterioration.

Validation of Instantaneous Respiratory Rate Using Reflectance PPG from Different Body Positions.

Respiratory rate (RR) is a key parameter used in healthcare for monitoring and predicting patient deterioration. However, continuous and automatic estimation of this parameter from wearable sensors is still a challenging task. Various methods have been proposed to estimate RR from wearable sensors using windowed segments of the data; e.g., often using a minimum of 32 s. Little research has been reported in the literature concerning the instantaneous detection of respiratory rate from such sources. In this paper, we develop and evaluate a method to estimate instantaneous respiratory rate (IRR) from body-worn reflectance photoplethysmography (PPG) sensors. The proposed method relies on a nonlinear time-frequency representation, termed the wavelet synchrosqueezed transform (WSST). We apply the latter to derived modulations of the PPG that arise from the act of breathing.We validate the proposed algorithm using (i) a custom device with a PPG probe placed on various body positions and (ii) a commercial wrist-worn device (WaveletHealth Inc., Mountain View, CA, USA). Comparator reference data were obtained via a thermocouple placed under the nostrils, providing ground-truth information concerning respiration cycles. Tracking instantaneous frequencies was performed in the joint time-frequency spectrum of the (4 Hz re-sampled) respiratory-induced modulation using the WSST, from data obtained from 10 healthy subjects. The estimated instantaneous respiratory rates have shown to be highly correlated with breath-by-breath variations derived from the reference signals. The proposed method produced more accurate results compared to averaged RR obtained using 32 s windows investigated with overlap between successive windows of (i) zero and (ii) 28 s. For a set of five healthy subjects, the averaged similarity between reference RR and instantaneous RR, given by the longest common subsequence (LCSS) algorithm, was calculated as 0.69; this compares with averaged similarity of 0.49 using 32 s windows with 28 s overlap between successive windows. The results provide insight into estimation of IRR and show that upper body positions produced PPG signals from which a better respiration signal was extracted than for other body locations.

Cognitive and behavioural strategies for weight management in overweight adults: Results from the Oxford Food and Activity Behaviours (OxFAB) cohort study.

BACKGROUND: Though many overweight and obese adults attempt to lose weight without formal support, little is known about the strategies used in self-directed weight loss attempts. We set out to assess cognitive and behavioural strategies for weight loss and their associations with weight change. METHODS: Prospective, web-based cohort study of overweight UK adults (BMI≥25kg/m2) trying to lose weight through behaviour change. Strategy use was assessed using the OxFAB questionnaire and evaluated (1) at the domain level, (2) through exploratory factor analysis, and (3) in a model of strategies deemed a priori to be "essential" to weight management. Associations with weight change at 3 months were tested using linear regression. RESULTS: 486 participants answered all questions; 194 reported weight at baseline and at 3 months (mean weight change -3.3kg (SD 4.1)). Greater weight loss was significantly associated with the motivational support domain (-2.4kg, 95% CI -4.4 to -0.4), dietary impulse control (from factor analysis) (-0.6kg, 95% CI -1.1 to -0.03), and weight loss planning and monitoring (from factor analysis) (-1.3kg, 95% CI -2.0 to -0.5). Higher scores in the model of essential behavioural strategies were significantly associated with greater weight loss (compared to participants using 6 or fewer of the 9 strategies, using 7 or more of the 9 strategies was associated with a 2.13kg greater weight loss (SE 0.58, p<0.001)). CONCLUSIONS: Despite heterogeneity in the strategies employed for weight loss, coherent patterns of behaviours emerged for individual participants, some of which were associated with greater weight loss, including strategies relating to dietary impulse control, weight loss planning and monitoring, motivational support, information seeking and self-monitoring. Trials could test the effect of promoting use of these patterns on weight loss.

Self-Management of Postnatal Hypertension: The SNAP-HT Trial.

Hypertension affects 1 in 10 pregnancies, often persisting postpartum, when antihypertensive requirements may vary substantially. This unmasked, randomized controlled trial evaluated the feasibility and effects on blood pressure (BP) of self-management of postpartum hypertension. Women with gestational hypertension or preeclampsia, requiring postnatal antihypertensive treatment, were randomized to self-management or usual care. Self-management entailed daily home BP monitoring and automated medication reduction via telemonitoring. Women attended 5 follow-up visits during 6 months. The primary outcome was feasibility: specifically recruitment, retention, and compliance with follow-up rates. Secondary outcomes included BP control and safety, analyzed on an intention-to-treat basis. Forty-nine percent (91/186) of those women approached were randomized (45 intervention, 46 control), and 90% (82/91) finished follow-up. The groups had similar baseline characteristics. After randomization, BP was lower in the intervention group, most markedly at 6 weeks: intervention group mean (SD), systolic 121.6 (8.7)/diastolic 80.5 (6.6) mm Hg; control group, systolic 126.6 (11.0)/diastolic 86.0 (9.7) mm Hg; adjusted differences (95% confidence interval), systolic -5.2 (-9.3 to -1.2)/diastolic -5.8 (-9.1 to -2.5) mm Hg. Diastolic BP remained significantly lower in those self-managing to 6 months: adjusted difference -4.5 (-8.1 to -0.8) mm Hg. This is the first randomized evaluation of BP self-management postpartum and indicates it would be feasible to trial this intervention in larger studies. Self-management resulted in better diastolic BP control to 6 months, even beyond medication cessation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02333240.

An m-Health system for education and motivation in cardiac rehabilitation: the experience of HeartCycle guided exercise.

Introduction Home-based programmes for cardiac rehabilitation play a key role in the recovery of patients with coronary artery disease. However, their necessary educational and motivational components have been rarely implemented with the help of modern mobile technologies. We developed a mobile health system designed for motivating patients to adhere to their rehabilitation programme by providing exercise monitoring, guidance, motivational feedback, and educational content. Methods Our multi-disciplinary approach is based on mapping "desired behaviours" into specific system's specifications, borrowing concepts from Fogg's Persuasive Systems Design principles. A randomised controlled trial was conducted to compare mobile-based rehabilitation (55 patients) versus standard care (63 patients). Results Some technical issues related to connectivity, usability and exercise sessions interrupted by safety algorithms affected the trial. For those who completed the rehabilitation (19 of 55), results show high levels of both user acceptance and perceived usefulness. Adherence in terms of started exercise sessions was high, but not in terms of total time of performed exercise or drop-outs. Educational level about heart-related health improved more in the intervention group than the control. Exercise habits at 6 months follow-up also improved, although without statistical significance. Discussion Results indicate that the adopted design methodology is promising for creating applications that help improve education and foster better exercise habits, but further studies would be needed to confirm these indications.

Nudging people with Type 2 diabetes towards better self-management through personalized risk communication: A pilot randomized controlled trial in primary care.

OBJECTIVES: To assess the feasibility in routine primary care consultation and investigate the effect on risk recall and self-management of a new type of risk communication intervention based on behavioural economics ("nudge-based") for people with Type 2 diabetes mellitus (T2DM). METHODS: Forty adults with poorly controlled T2DM (HbA1c > 7.5%) were randomized to receive a personalized, nudge-based risk communication intervention (n = 20) or standard care (n = 20). Risk recall and self-management were evaluated at baseline and 12 weeks after the intervention. RESULTS: Both in terms of feasibility and acceptability, this new risk communication intervention was very satisfactory. Study retention rate after 12 weeks was very high (90%) and participants were highly satisfied with the intervention (4.4 out of 5 on the COMRADE scale). Although not powered to identify significant between-group effects, the intervention significantly improved risk recall after 12 weeks and intentions to make lifestyle changes (dietary behaviour) compared to standard care. CONCLUSIONS: This pilot study provides the first evidence of the feasibility of implementing in primary care a nudge-based risk communication intervention for people with T2DM. Based on the promising results observed, an adequately powered trial to determine the effectiveness of the intervention on long-term self-management is judged feasible. As a result of this feasibility study, some minor adaptations to the intervention and study methods that would help to facilitate a definitive trial are also reported.

Pregnancy physiology pattern prediction study (4P study): protocol of an observational cohort study collecting vital sign information to inform the development of an accurate centile-based obstetric early warning score.

INTRODUCTION: Successive confidential enquiries into maternal deaths in the UK have identified an urgent need to develop a national early warning score (EWS) specifically for pregnant or recently pregnant women to aid more timely recognition, referral and treatment of women who are developing life-threatening complications in pregnancy or the puerperium. Although many local EWS are in use in obstetrics, most have been developed heuristically. No current obstetric EWS has defined the thresholds at which an alert should be triggered using evidence-based normal ranges, nor do they reflect the changing physiology that occurs with gestation during pregnancy. METHODS AND ANALYSIS: An observational cohort study involving 1000 participants across three UK sites in Oxford, London and Newcastle. Pregnant women will be recruited at approximately 14 weeks' gestation and have their vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature) measured at 4 to 6-week intervals during pregnancy. Vital signs recorded during labour and delivery will be extracted from hospital records. After delivery, participants will measure and record their own vital signs daily for 2 weeks. During the antenatal and postnatal periods, vital signs will be recorded on an Android tablet computer through a custom software application and transferred via mobile internet connection to a secure database. The data collected will be used to define reference ranges of vital signs across normal pregnancy, labour and the immediate postnatal period. This will inform the design of an evidence-based obstetric EWS. ETHICS AND DISSEMINATION: The study has been approved by the NRES committee South East Coast-Brighton and Sussex (14/LO/1312) and is registered with the ISRCTN (10838017). All participants will provide written informed consent and can withdraw from the study at any point. All data collected will be managed anonymously. The findings will be disseminated in international peer-reviewed journals and through research conferences.