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Engineering a mobile health tool for resource-poor settings to assess and manage cardiovascular disease risk: SMARThealth study.

16 October 2018

The incidence of chronic diseases in low- and middle-income countries is rapidly increasing both in urban and rural regions. A major challenge for health systems globally is to develop innovative solutions for the prevention and control of these diseases. This paper discusses the development and pilot testing of SMARTHealth, a mobile-based, point-of-care Clinical Decision Support (CDS) tool to assess and manage cardiovascular disease (CVD) risk in resource-constrained settings. Through pilot testing, the preliminary acceptability, utility, and efficiency of the CDS tool was obtained.The CDS tool was part of an mHealth system comprising a mobile application that consisted of an evidence-based risk prediction and management algorithm, and a server-side electronic medical record system. Through an agile development process and user-centred design approach, key features of the mobile application that fitted the requirements of the end users and environment were obtained. A comprehensive analytics framework facilitated a data-driven approach to investigate four areas, namely, system efficiency, end-user variability, manual data entry errors, and usefulness of point-of-care management recommendations to the healthcare worker. A four-point Likert scale was used at the end of every risk assessment to gauge ease-of-use of the system.The system was field-tested with eleven village healthcare workers and three Primary Health Centre doctors, who screened a total of 292 adults aged 40 years and above. 34% of participants screened by health workers were identified by the CDS tool to be high CVD risk and referred to a doctor. In-depth analysis of user interactions found the CDS tool feasible for use and easily integrable into the workflow of healthcare workers. Following completion of the pilot, further technical enhancements were implemented to improve uptake of the mHealth platform. It will then be evaluated for effectiveness and cost-effectiveness in a cluster randomized controlled trial involving 54 southern Indian villages and over 16000 individuals at high CVD risk.An evidence-based CVD risk prediction and management tool was used to develop an mHealth platform in rural India for CVD screening and management with proper engagement of health care providers and local communities. With over a third of screened participants being high risk, there is a need to demonstrate the clinical impact of the mHealth platform so that it could contribute to improved CVD detection in high risk low resource settings.

Using a mobile health application to support self-management in chronic obstructive pulmonary disease: a six-month cohort study.

16 October 2018

Self-management strategies have the potential to support patients with chronic obstructive pulmonary disease (COPD). Telehealth interventions may have a role in delivering this support along with the opportunity to monitor symptoms and physiological variables. This paper reports findings from a six-month, clinical, cohort study of COPD patients' use of a mobile telehealth based (mHealth) application and how individually determined alerts in oxygen saturation levels, pulse rate and symptoms scores related to patient self-initiated treatment for exacerbations.The development of the mHealth intervention involved a patient focus group and multidisciplinary team of researchers, engineers and clinicians. Individual data thresholds to set alerts were determined, and the relationship to exacerbations, defined by the initiation of stand-by medications, was measured. The sample comprised 18 patients (age range of 50-85 years) with varied levels of computer skills.Patients identified no difficulties in using the mHealth application and used all functions available. 40% of exacerbations had an alert signal during the three days prior to a patient starting medication. Patients were able to use the mHealth application to support self- management, including monitoring of clinical data. Within three months, 95% of symptom reporting sessions were completed in less than 100 s.Home based, unassisted, daily use of the mHealth platform is feasible and acceptable to people with COPD for reporting daily symptoms and medicine use, and to measure physiological variables such as pulse rate and oxygen saturation. These findings provide evidence for integrating telehealth interventions with clinical care pathways to support self-management in COPD.

Trial protocol to compare the efficacy of a smartphone-based blood glucose management system with standard clinic care in the gestational diabetic population.

16 October 2018

The prevalence of gestational diabetes mellitus (GDM) is rising in the UK. Good glycaemic control improves maternal and neonatal outcomes. Frequent clinical review of patients with GDM by healthcare professionals is required owing to the rapidly changing physiology of pregnancy and its unpredictable course. Novel technologies that allow home blood glucose (BG) monitoring with results transmitted in real time to a healthcare professional have the potential to deliver good-quality healthcare to women more conveniently and at a lower cost to the patient and the healthcare provider compared to the conventional face-to-face or telephone-based consultation. We have developed an integrated GDm-health management system and aim to test the impact of using this system on maternal glycaemic control, costs, patient satisfaction and maternal and neonatal outcomes compared to standard clinic care in a single large publicly funded (National Health Service (NHS)) maternity unit.Women with confirmed gestational diabetes in a current pregnancy are individually randomised to either the GDm-health system and half the normal clinic visits or normal clinic care. Primary outcome is mean BG in each group from recruitment to delivery calculated, with adjustments made for number of BG measurements, proportion of preprandial and postprandial readings and length of time in study, and compared between the groups. The secondary objective will be to compare the two groups for compliance to the allocated BG monitoring regime, maternal and neonatal outcomes, glycaemic control using glycated haemoglobin (HbA1c) and other BG metrics, and patient attitudes to care assessed using a questionnaire and resource use.Thresholds for treatment, dietary advice and clinical management are the same in both groups. The results of the study will be published in a peer-reviewed journal and disseminated electronically and in print.NCT01916694; Pre-results.

Implementing an electronic observation and early warning score chart in the emergency department: a feasibility study.

16 October 2018

Use of automated systems to aid identification of patient deterioration in routine hospital practice is limited and their impact on patient outcomes remains unclear. This study was designed to evaluate the feasibility of implementing an electronic observation chart with automated early warning score (EWS) calculation in the high-acuity area of an emergency department.This study enrolled 3219 participants before and 3352 after implementation of an automated system, using bedside vital-sign entry on networked mobile devices. The primary outcome measure was the percentage of participants for whom an EWS was accurately recorded at each stage.Of the participants, 52.7% before and 92.9% after implementation of the electronic system had an accurate EWS recorded on charts available to the study team. Participant groups were well balanced for baseline characteristics and acuity.In this study, the feasibility and limitations of implementing an electronic observation chart in the ED were demonstrated. Accurate EWS documentation was more frequent after implementation of the electronic observation chart. Retrospective analysis suggests that the use of an electronic observation system may lead to a greater percentage of observations being taken from those patients with a higher EWS.

Use of wearable monitoring devices to change health behavior.

16 October 2018

Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial.

16 October 2018

Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.NCT02019823.

Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial.

16 October 2018

We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure.In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure <140/90 mm Hg were 1.42 (95% confidence interval, 1.03-1.95) for information-only messaging and 1.41 (95% confidence interval, 1.02-1.95) for interactive messaging compared with usual care.In this randomized trial of an automated adherence support program delivered by SMS text message in a general outpatient population of adults with high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect.URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141.

Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial.

16 October 2018

The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education.The EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months.The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the study will be disseminated through peer review publications and conference presentations.Current controlled trials ISRCTN40367841.

Respiratory rate estimation during triage of children in hospitals.

16 October 2018

Accurate assessment of a child's health is critical for appropriate allocation of medical resources and timely delivery of healthcare in Emergency Departments. The accurate measurement of vital signs is a key step in the determination of the severity of illness and respiratory rate is currently the most difficult vital sign to measure accurately. Several previous studies have attempted to extract respiratory rate from photoplethysmogram (PPG) recordings. However, the majority have been conducted in controlled settings using PPG recordings from healthy subjects. In many studies, manual selection of clean sections of PPG recordings was undertaken before assessing the accuracy of the signal processing algorithms developed. Such selection procedures are not appropriate in clinical settings. A major limitation of AR modelling, previously applied to respiratory rate estimation, is an appropriate selection of model order. This study developed a novel algorithm that automatically estimates respiratory rate from a median spectrum constructed applying multiple AR models to processed PPG segments acquired with pulse oximetry using a finger probe. Good-quality sections were identified using a dynamic template-matching technique to assess PPG signal quality. The algorithm was validated on 205 children presenting to the Emergency Department at the John Radcliffe Hospital, Oxford, UK, with reference respiratory rates up to 50 breaths per minute estimated by paediatric nurses. At the time of writing, the authors are not aware of any other study that has validated respiratory rate estimation using data collected from over 200 children in hospitals during routine triage.

Telemedicine Technologies for Diabetes in Pregnancy: A Systematic Review and Meta-Analysis.

16 October 2018

Diabetes in pregnancy is a global problem. Technological innovations present exciting opportunities for novel approaches to improve clinical care delivery for gestational and other forms of diabetes in pregnancy.To perform an updated and comprehensive systematic review and meta-analysis of the literature to determine whether telemedicine solutions offer any advantages compared with the standard care for women with diabetes in pregnancy.The review was developed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. Randomized controlled trials (RCT) in women with diabetes in pregnancy that compared telemedicine blood glucose monitoring with the standard care were identified. Searches were performed in SCOPUS and PubMed, limited to English language publications between January 2000 and January 2016. Trials that met the eligibility criteria were scored for risk of bias using the Cochrane Collaborations Risk of Bias Tool. A meta-analysis was performed using Review Manager software version 5.3 (Nordic Cochrane Centre, Cochrane Collaboration).A total of 7 trials were identified. Meta-analysis demonstrated a modest but statistically significant improvement in HbA1c associated with the use of a telemedicine technology. The mean HbA1c of women using telemedicine was 5.33% (SD 0.70) compared with 5.45% (SD 0.58) in the standard care group, representing a mean difference of -0.12% (95% CI -0.23% to -0.02%). When this comparison was limited to women with gestational diabetes mellitus (GDM) only, the mean HbA1c of women using telemedicine was 5.22% (SD 0.70) compared with 5.37% (SD 0.61) in the standard care group, mean difference -0.14% (95% CI -0.25% to -0.04%). There were no differences in other maternal and neonatal outcomes reported.There is currently insufficient evidence that telemedicine technology is superior to standard care for women with diabetes in pregnancy; however, there was no evidence of harm. No trials were identified that assessed patient satisfaction or cost of care delivery, and it may be in these areas where these technologies may be found most valuable.