Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial.

BACKGROUND: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. METHODS: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. RESULTS: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. CONCLUSION: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. TRIAL REGISTRATION: ISCTRN ISRCTN13404264. Registered on 10 October 2018.

Effect of Self-monitoring of Blood Pressure on Blood Pressure Control in Pregnant Individuals With Chronic or Gestational Hypertension: The BUMP 2 Randomized Clinical Trial.

Importance: Inadequate management of elevated blood pressure is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. Objective: To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks' gestation) or with gestational hypertension (enrolled between 20 and 37 weeks' gestation). Final follow-up was in May 2020. Interventions: Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n = 430) or to usual care alone (n = 420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. Main Outcomes and Measures: The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Results: Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, -1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, -0.03 mm Hg [95% CI, -2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Conclusions and Relevance: Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial.

Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone-based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial. OBJECTIVE: The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for reducing cardiovascular risk in people with type 2 diabetes by comparing it with usual care. METHODS: The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, at 13 and 26 weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group), the trial is powered at 92.5% to detect a 4-percentage point difference in cardiovascular risk. The analysis will follow a prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention. RESULTS: The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024. CONCLUSIONS: This trial will provide evidence regarding the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32918.

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.

Recruiting patients to a digital self-management study whilst in hospital for a chronic obstructive pulmonary disease exacerbation: A feasibility analysis.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are often hospitalised with acute exacerbations (AECOPD) and many patients get readmitted. Intervening with hospitalised patients may be optimal timing to provide support. Our previous work demonstrated use of a digital monitoring and self-management support tool in the community. However, we wanted to explore the feasibility of recruiting patients whilst hospitalised for an AECOPD, and to identify the rate of dropout attrition around admission for AECOPD. METHODS: Patients were recruited to the EDGE2 study between May 2019 and March 2020. Patients were identified by the clinical teams and patients were recruited by members of the clinical research team. Participants were aged 40 years or older, had a diagnosis of COPD and were attending or admitted to hospital for an AECOPD. Participants were given a tablet computer, Bluetooth-linked pulse oximeter and wrist-worn physical activity monitor to use until 6 months post-discharge. Use of the system aimed to support COPD self-management by enabling self-monitoring of vital signs, COPD symptoms, mood and physical activity, and access to multi-media educational resources. RESULTS: 281 patients were identified and 126 approached. The main referral source was the specialist respiratory nursing and physiotherapist team (49.8% of patients identified). Twenty-six (37.1%) patients were recruited. As of 21 April 2020, 14 (53.8%) participants withdrew and 11 (of 14; 78.6%) participants withdrew within four weeks of discharge. The remaining participants withdrew between one and three months follow-up (1 of 14; 7.1%) and between three and six months follow-up (2 of 14; 14.3%). CONCLUSION: A large number of patients were screened to recruit a relatively small sample and a high rate of dropout was observed. It does not appear feasible to recruit patients with COPD to digital interventional studies from the hospital setting when they have the burden of coping with acute illness.

Correction: System Architecture for "Support Through Mobile Messaging and Digital Health Technology for Diabetes" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies.

[This corrects the article DOI: 10.2196/18460.].

System Architecture for "Support Through Mobile Messaging and Digital Health Technology for Diabetes" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies.

BACKGROUND: Diabetes is a highly prevalent long-term condition with high morbidity and mortality rates. People with diabetes commonly worry about their diabetes medicines and do not always take them regularly as prescribed. This can lead to poor diabetes control. The Support Through Mobile Messaging and Digital Health Technology for Diabetes (SuMMiT-D) study aims to deliver brief messages as tailored interventions to support people with type 2 diabetes in better use of their diabetes medicines and to improve treatment adherence and health outcomes. OBJECTIVE: This paper describes the overall architecture of a tailored intervention delivery system used in the pilot and randomized controlled feasibility studies of SuMMiT-D and reports its performance. METHODS: The SuMMiT-D system includes several platforms and resources to recruit participants and deliver messages as tailored interventions. Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them. The personalization and tailoring of brief messages for each participant is based on a list of built-in commands that they can use. RESULTS: For the pilot study, a total of 48 participants were recruited; they had a median age of 64 years (first quartile, third quartile [Q1, Q3: 54.5, 69]). For the feasibility study, a total of 209 participants were recruited and randomly assigned to either the control or intervention group; they had a median age of 65 years (Q1, Q3: 56, 71), with 41.1% (86/209) being female. The participants used the SuMMiT-D system for up to 6 months (26 weeks) and had a wide range of different interactions with the SuMMiT-D system while tailored interventions were being delivered. For both studies, we had low withdrawal rates: only 4.2% and 5.3% for the pilot and feasibility studies, respectively. CONCLUSIONS: A system was developed to successfully deliver brief messages as tailored health interventions to more than 250 people with type 2 diabetes via SMS text messages. On the basis of the low withdrawal rates and positive feedback received, it can be inferred that the SuMMiT-D system is robust, user-friendly, useful, and positive for most participants. From the two studies, we found that online recruitment was more efficient than recruitment via postal mail; a regular SMS text reminder (eg, every 4 weeks) can potentially increase the participants' interactions with the system. TRIAL REGISTRATION: ISRCTN Registry ISRCTN13404264; http://www.isrctn.com/ISRCTN13404264.

Toward a Multivariate Prediction Model of Pharmacological Treatment for Women With Gestational Diabetes Mellitus: Algorithm Development and Validation.

BACKGROUND: Successful management of gestational diabetes mellitus (GDM) reduces the risk of morbidity in women and newborns. A woman's blood glucose readings and risk factors are used by clinical staff to make decisions regarding the initiation of pharmacological treatment in women with GDM. Mobile health (mHealth) solutions allow the real-time follow-up of women with GDM and allow timely treatment and management. Machine learning offers the opportunity to quickly analyze large quantities of data to automatically flag women at risk of requiring pharmacological treatment. OBJECTIVE: The aim of this study is to assess whether data collected through an mHealth system can be analyzed to automatically evaluate the switch to pharmacological treatment from diet-based management of GDM. METHODS: We collected data from 3029 patients to design a machine learning model that can identify when a woman with GDM needs to switch to medications (insulin or metformin) by analyzing the data related to blood glucose and other risk factors. RESULTS: Through the analysis of 411,785 blood glucose readings, we designed a machine learning model that can predict the timing of initiation of pharmacological treatment. After 100 experimental repetitions, we obtained an average area under the receiver operating characteristic curve of 0.80 (SD 0.02) and an algorithm that allows the flexibility of setting the operating point rather than relying on a static heuristic method, which is currently used in clinical practice. CONCLUSIONS: Using real-time data collected via an mHealth system may further improve the timeliness of the intervention and potentially improve patient care. Further real-time clinical testing will enable the validation of our algorithm using real-world data.

Optimizing a digital intervention for managing blood pressure in stroke patients using a diverse sample: Integrating the person-based approach and patient and public involvement.

BACKGROUND: Having a stroke or transient ischaemic attack increases the risk of a subsequent one, especially with high blood pressure (BP). Home-based BP management can be effective at maintaining optimal BP. OBJECTIVE: To describe the optimization of a digital intervention for stroke patients and the value of participant diversity, using the person-based approach (PBA) and integral patient and public involvement (PPI). SETTING AND PARTICIPANTS: Stroke patients recruited from primary care and community settings, and health-care professionals in primary care, in England and Ireland. DESIGN: Three linked qualitative studies conducted iteratively to develop an intervention using the PBA, with integral PPI. INTERVENTION: The BP: Together intervention, adapted from existing BP self-monitoring interventions, is delivered via mobile phone or web interface to support self-monitoring of BP at home. It alerts patients and their clinicians when a change in antihypertensive medication is needed. FINDINGS: Feedback from a diverse range of participants identified potential barriers, which were addressed to improve the intervention accessibility, feasibility and persuasiveness. Easy-to-read materials were developed to improve usability for patients with aphasia and lower literacy. The importance of including family members who support patient care was also highlighted. Feedback messages regarding medication change were refined to ensure usefulness for patients and clinicians. DISCUSSION: Input from PPI alongside qualitative research with a diverse study sample allowed the creation of a simple and equitable BP management intervention for stroke patients. PATIENT INVOLVEMENT: Two PPI co-investigators contributed to design, conduct of study, data interpretation and manuscript preparation; community PPI sessions informed early planning. Study participants were stroke patients and family members.

Monitoring activity of hip injury patients (MoHIP): a sub-study of the World Hip Trauma Evaluation observational cohort study.

BACKGROUND: Hip fracture is common, affecting 20% of women and 10% of men during their lifetime. The trajectory of patients' recovery as they transition from the acute hospital setting to their usual residence is poorly understood. Recently, the use of activity trackers to monitor physical activity during recovery has been investigated as a way to explore this trajectory. METHODS: This prospective observational cohort study followed patients from hospital to home as they recovered from a hip fracture. Participants were recruited from a single centre and provided with a 3-axis logging accelerometer worn as a pendant, for 16 weeks from recruitment. Participants received monthly follow-up visits which included questions about wearing the monitor. Monthly activity monitor data were also downloaded. Participant activity was estimated from the monitor data using the calibrated "Euclidean Norm Minus One" (ENMO) metric. Polynomial mixed-effects modelling was used to evaluate the difference between the weekly activity trends of 2 groups of participants: those with and without independent mobility at 16 weeks (defined by whether aids or personal assistance were required to mobilise). RESULTS: Twenty-nine participants from 125 eligible patients were recruited. Of these, 19 (66%) reported being aware of wearing the monitor at least some of the time. Fourteen (48%) participants withdrew before study completion. Data for thirteen (45%) participants were of sufficient quantity to be included in the activity modelling procedure. Of these, 8 reported independent mobility at 16 weeks post-surgery, and 5 did not. By week 7, the weekly predicted mean ENMO ( ENMO ¯ W ) values were significantly different between the two participant groups, demonstrating feasibility of the model's ability to predict which patients will report independent mobility at 16 weeks. CONCLUSIONS: This is the first study to our knowledge to investigate acceptability and feasibility of a pendant-worn activity monitor in this patient cohort. Acceptability of wearing the monitor and feasibility of recruitment and retention of participants were limited. Future research into the use of activity monitors in this population should use minimally intrusive devices which are acceptable to this population. STUDY REGISTRATION: MoHIP is a sub-study of the World Hip Trauma Evaluation (WHiTE) Study (ISRCTN 63982700).

Self-reported and objectively measured physical activity in people with and without chronic heart failure: UK Biobank analysis.

Objective: The impact of heart failure (HF) on perceived and objectively measured levels of physical activity (PA) can inform risk stratification and treatment recommendation. We aimed to compare self-reported and objectively measured PA levels in a large sample of participants with and without HF. Methods: A validated PA questionnaire was used to estimate self-reported weekly PA among 1600 participants with HF and 387 580 participants without HF. Accelerometer data were studied in 596 participants with HF and 96 105 participants without HF for a period of 7 days. Using multivariable linear regression models, we compared the PA levels between participants with HF and without HF, focusing on both the average daily PA levels and the intensity of PAs throughout the day. Results: PA levels were significantly lower in participants with HF using both self-report (excess metabolic equivalent of task hours per week of 26.5 (95% CI 24.7 to 28.4) vs 34.7 (95% CI 34.5 to 34.9), respectively (p<0.001)) and accelerometer measures (mean accelerations of 23.7 milligravity (95% CI 23.1 to 24.4) vs 28.1 milligravity (95% CI 28.0 to 28.1), respectively (p<0.001)). Findings were consistent across different PA intensities. Hour-by-hour comparisons showed that accelerometer-derived PA levels of patients with HF were reduced throughout the day. Conclusion: Perceived and objectively recorded PA levels of patients with chronic HF are significantly lower than those of individuals without HF. This difference is continuous throughout the different hours of the day, with individuals with HF being on average 16% less active than individuals without HF. In patients with HF, increases in everyday activity may be a potential alternative to structured exercise programmes.

Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials.

INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2). METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice. ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women. TRIAL REGISTRATION NUMBER: NCT03334149.

Mood Monitoring Over One Year for People With Chronic Obstructive Pulmonary Disease Using a Mobile Health System: Retrospective Analysis of a Randomized Controlled Trial.

BACKGROUND: Comorbid anxiety and depression can add to the complexity of managing treatment for people living with chronic obstructive pulmonary disease (COPD). Monitoring mood has the potential to identify individuals who might benefit from additional support and treatment. OBJECTIVE: We used data from the sElf-management anD support proGrammE (EDGE) trial to examine: (1) the extent to which the mood-monitoring components of a mobile health system for patients with COPD were used by participants; (2) the levels of anxiety and depression symptoms among study participants; (3) the extent to which videos providing advice about coping with low mood were viewed; and (4) the characteristics of participants with differing levels of mood and utilization of mood monitoring. METHODS: A total of 107 men and women with a clinical diagnosis of COPD, aged ≥40 years old, were recruited to the intervention arm of the EDGE trial. Participants were invited to complete the Patient Health Questionnaire-8 and the Generalized Anxiety Disorder-7 test every four weeks using a tablet computer. Mood disturbance based on these measures was defined as a score ≥5 on either scale. Participants reporting a mood disturbance were automatically directed (signposted) to a stress or mood management video. Study outcomes included measures of health status, respiratory quality of life, and symptoms of anxiety and depression. RESULTS: Overall, 94 (87.9%) participants completed the 12-month study. A total of 80 participants entered at least one response each month for at least ten months. On average, 16 participants (range 8-38 participants) entered ≥2 responses each month. Of all the participants, 47 (50%) gave responses indicating a mood disturbance. Participants with a mood disturbance score for both scales (n=47) compared with those without (n=20) had lower health status (P=.008), lower quality of life (P=.009), and greater anxiety (P<.001) and increased depression symptoms (P<.001). Videos were viewed by 64 (68%) people over 12 months. Of the 220 viewing visualizations, 70 (34.7%) began after being signposted. Participants signposted to the stress management video (100%; IQR 23.3-100%) watched a greater proportion of it compared to those not signposted (38.4%; IQR 16.0-68.1%; P=.03), whereas duration of viewing was not significantly different for the mood management video. CONCLUSIONS: Monitoring of anxiety and depression symptoms for people with COPD is feasible. More than half of trial participants reported scores indicating a mood disturbance during the study. Signposting participants to an advisory video when reporting increased symptoms of a mood disturbance resulted in a longer view-time for the stress management video. The opportunity to elicit measures of mood regularly as part of a health monitoring system could contribute to better care for people with COPD.

Intervention planning and modification of the BUMP intervention: a digital intervention for the early detection of raised blood pressure in pregnancy.

BACKGROUND: Hypertensive disorders in pregnancy, particularly pre-eclampsia, pose a substantial health risk for both maternal and foetal outcomes. The BUMP (Blood Pressure Self-Monitoring in Pregnancy) interventions are being tested in a trial. They aim to facilitate the early detection of raised blood pressure through self-monitoring. This article outlines how the self-monitoring interventions in the BUMP trial were developed and modified using the person-based approach to promote engagement and adherence. METHODS: Key behavioural challenges associated with blood pressure self-monitoring in pregnancy were identified through synthesising qualitative pilot data and existing evidence, which informed guiding principles for the development process. Social cognitive theory was identified as an appropriate theoretical framework. A testable logic model was developed to illustrate the hypothesised processes of change associated with the intervention. Iterative qualitative feedback from women and staff informed modifications to the participant materials. RESULTS: The evidence synthesis suggested women face challenges integrating self-monitoring into their lives and that adherence is challenging at certain time points in pregnancy (for example, starting maternity leave). Intervention modification included strategies to address adherence but also focussed on modifying outcome expectancies, by providing messages explaining pre-eclampsia and outlining the potential benefits of self-monitoring. CONCLUSIONS: With an in-depth understanding of the target population, several methods and approaches to plan and develop interventions specifically relevant to pregnant women were successfully integrated, to address barriers to behaviour change while ensuring they are easy to engage with, persuasive and acceptable.

Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D Feasibility): a randomised feasibility trial protocol.

INTRODUCTION: Type 2 diabetes is common, affecting over 400 million people worldwide. Risk of serious complications can be reduced through use of effective treatments and active self-management. However, people are often concerned about starting new medicines and face difficulties in taking them regularly. Use of brief messages to provide education and support self-management, delivered through mobile phone-based text messages, can be an effective tool for some long-term conditions. We have developed messages aiming to support patients' self-management of type 2 diabetes in the use of medications and other aspects of self-management, underpinned by theory and evidence. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the intervention, compared with usual care. METHODS AND ANALYSIS: The feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England. Consenting participants will be randomised to receive short text messages three times a week with messages designed to produce change in medication adherence or non-health-related messages for 6 months. The aims are to test recruitment methods, retention to the study, the feasibility of data collection and the mobile phone and web-based processes of a proposed definitive trial and to refine the text messaging intervention. The primary outcome is the rate of recruitment to randomisation of participants to the trial. Data, including patient reported measures, will be collected online at baseline and the end of the 6-month follow-up period. With 200 participants (100 in each group), this trial is powered to estimate 80% follow-up within 95% CIs of 73.8% to 85.3%. The analysis will follow a prespecified plan. ETHICS AND DISSEMINATION: Ethics approval was obtained from the West of Scotland Research Ethics Committee 05. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: www.summit-d.org (SuMMiT-D (SUpport through Mobile Messaging and digital health Technology for Diabetes)). TRIAL REGISTRATION NUMBER: ISRCTN13404264.

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.

Clinical Implications of the NICE 2015 Criteria for Gestational Diabetes Mellitus.

BACKGROUND: In response to concerns that the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria labeled too many women with gestational diabetes mellitus (GDM) without evidence of clinical or economic benefit, NICE recommended a change in diagnostic criteria in 2015. AIM: To compare diabetes associated maternal and neonatal complications in pregnancies complicated by GDM diagnosed using IADPSG criteria only, to those with GDM diagnosed using both IADPSG and NICE 2015 criteria. GDM screening was risk factor based. METHODS: This was a secondary analysis of a trial of women with GDM diagnosed by the IADPSG criteria (fasting blood glucose (BG) ≥ 5.1 mmol/L, 1 h ≥ 10.0 mmol/L and 2 h ≥ 8.5 mmol/L). Outcomes were compared for two groups: NICE + IADPSG defined as those with GDM diagnosed by both the NICE 2015 and IADPSG criteria (fasting BG ≥ 5.6 mmol/L, 2 h ≥ 8.5 mmol/L); and IADPSG-ONLY (fasting BG 5.1 mmol/L to 5.5 mmol/L, and/or 1-hour ≥10.0 mmol/L, and 2 h ≥ 8.5 mmol/L). We were not able to obtain data for women with a 2-h value between BG 7.8⁻8.4 mmol/L (i.e., NICE-ONLY; NICE 2015 positive and IADPSG negative). All women were treated for GDM using targets of fasting BG < 5.3 mmol/L and 1-h post prandial BG < 7.8 mmol/L respectively. RESULTS: Of 159 women, 65 (40.9%) were NICE + IADPSG and 94 (59.1%) IADPSG-ONLY. Hypoglycaemic medication use was similar in both groups: 52.3% NICE + IADPSG, 46.8% IADPSG-ONLY, OR 1.0 (0.5⁻1.9). The IADPSG-ONLY group delivered later than the NICE + IADPSG group; 39.0 weeks (sd 1.4) compared to 38.2 weeks (sd 2.5), p value 0.02. Fewer caesarean sections occurred in IADPSG-ONLY group 30.9% vs. 52.3%, OR 0.4 (0.2⁻0.9). Birthweight, large for gestational age, and other neonatal complications were not significantly different between groups. CONCLUSIONS: Gestational diabetes-associated perinatal complications were similar in both groups. The IADPSG criteria detect women with evidence of ongoing hyperglycaemia who may benefit from treatment during pregnancy.

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.