Recent telehealth studies have demonstrated minor impact on patients affected by long-term conditions. The use of technology does not guarantee the compliance required for sustained collection of high-quality symptom and physiological data. Remote monitoring alone is not sufficient for successful disease management. A patient-centred design approach is needed in order to allow the personalisation of interventions and encourage the completion of daily self-management tasks. A digital health system was designed to support patients suffering from chronic obstructive pulmonary disease in self-managing their condition. The system includes a mobile application running on a consumer tablet personal computer and a secure backend server accessible to the health professionals in charge of patient management. The patient daily routine included the completion of an adaptive, electronic symptom diary on the tablet, and the measurement of oxygen saturation via a wireless pulse oximeter. The design of the system was based on a patient-centred design approach, informed by patient workshops. One hundred and ten patients in the intervention arm of a randomised controlled trial were subsequently given the tablet computer and pulse oximeter for a 12-month period. Patients were encouraged, but not mandated, to use the digital health system daily. The average used was 6.0 times a week by all those who participated in the full trial. Three months after enrolment, patients were able to complete their symptom diary and oxygen saturation measurement in less than 1 m 40s (96% of symptom diaries). Custom algorithms, based on the self-monitoring data collected during the first 50 days of use, were developed to personalise alert thresholds. Strategies and tools aimed at refining a digital health intervention require iterative use to enable convergence on an optimal, usable design. 'Continuous improvement' allowed feedback from users to have an immediate impact on the design of the system (e.g., collection of quality data), resulting in high compliance with self-monitoring over a prolonged period of time (12-month). Health professionals were prompted by prioritisation algorithms to review patient data, which led to their regular use of the remote monitoring website throughout the trial. Trial registration: ISRCTN40367841 . Registered 17/10/2012.
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.
Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care.
Methods
This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366.
Findings
1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, −3·5 mm Hg [95% CI −5·8 to −1·2]; telemonitoring, −4·7 mm Hg [–7·0 to −2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference −1·2 mm Hg [95% CI −3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups.
Interpretation
Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care.
Funding
National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.
Chronic Obstructive Pulmonary Disease (COPD) is a progressive chronic disease, predicted to become the third leading cause of death by 2030. COPD patients are at risk of sudden and acute worsening of symptoms, reducing the patient's quality of life and leading to hospitalization. We present the results of a pilot study with 18 COPD patients using an m-Health system, based on a tablet computer and pulse oximeter, for a period of six months. For prioritizing patients for clinical review, a data-driven approach has been developed which generates personalized alerts using the electronic symptom diary, pulse rate, blood oxygen saturation, and respiratory rate derived from oximetry data. This work examines the advantages of multivariate novelty detection over univariate approaches and shows the benefit of including respiratory rate as a predictor.
Probiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited.To determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents.Placebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018.Study participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year.The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year.Among 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group.Among care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting.ISRCTN Identifier:16392920.
Introduction: Previous qualitative research into telehealth and chronic conditions has identified opportunities and challenges of such interventions as perceived by patients. Since people with COPD tend to be over the age of 60 years, there is a preconception that this patient group may find the use of mobile Health (mHealth) systems more challenging than younger patients. The EDGE COPD project aims to evaluate the efficacy of a multi-component mHealth intervention to improve quality of life in patients with COPD. As part of this, a feasibility study has been conducted to optimise this intervention, and this included a qualitative component to explore opportunities for, and difficulties of, using this system as identified by patients themselves. This paper presents the qualitative findings of the feasibility study. Aims: To explore the expectations and experiences of using an mHealth application of people living with COPD in the community; and how such a system may impact on their perceived wellbeing and ability to self-manage at home. Methods: We carried out a qualitative study to which patients were recruited using purposive sampling to achieve maximum variation. Patients, meeting the inclusion criteria (diagnosis of COPD, > 40 years of age, MRC dyspnoea scale ≥ 2, smoking history > 10 pack years) and consenting, were interviewed when given the mHealth system and after a 6 month period. Interviews followed a semi-structured interview guide to explore participants’ experience of their condition and use of the mHealth application. Data were audio-recorded, transcribed verbatim, imported into NVivo (a software programme facilitating qualitative analysis) and analysed using a grounded theory approach, incorporating constant comparative analysis, open, axial and selective coding to identify similarities and differences of participants’ interview accounts. Results: Nineteen participants with moderate to very severe COPD were interviewed pre and post mHealth intervention. The sample consisted of 10 men and 9 women with an age range of 5085 International Congress on Telehealth and Telecare 2013, London, July 01-03, 2013. 2 International Journal of Integrated Care –Volume 13, 20 November –URN:NBN:NL:UI:10-1-115700– http://www.ijic.org/ years and different levels of computer skills. Participants identified no particular difficulties in using the mHealth application regardless of their computer skills and experience and the use of the mHealth application appeared to fit well with participants’ everyday routines. The main themes encapsulating participants’ experience of using the mHealth application related to increased awareness of the variability of their symptoms (onset of exacerbation and recovery time), reassurance through monitoring (continuity of care) and improved management of COPD information. Conclusion: These findings provide further insight into how telehealth can improve patients’ perceived well-being and ability to self-manage. In addition, the mHealth application may be able to provide improved continuity of care as perceived by patients. The findings will also inform the design and conduct of the randomised controlled efficacy trial to ensure the system can be used by patients regardless of their previous experience with communication technologies.
Introduction: With the convergence of computing and communications in smart phones and computer tablets, m-health is playing an increasing role in the remote monitoring of patients with chronic illnesses.We have shown in recent trials that its use for interventions lasting up to six months improves patient outcomes.
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