Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial.

BACKGROUND: Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS: We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION: PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION: https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.

A cross-country time and motion study to measure the impact of electronic medication management systems on the work of hospital pharmacists in Australia and England.

BACKGROUND: Qualitative studies have provided important insights into how hospital pharmacists' work changes when electronic medication management (EMM) systems are introduced. Quantitative studies of work practice change are rare. Despite the use of EMM systems internationally, there are no cross-country comparative studies of their impact on health professionals' work. We aimed to quantify and compare the type and magnitude of changes in hospital pharmacists' work pre- and post-EMM implementation in two countries. METHODS: Parallel, direct observational, time and motion studies of pharmacists in Australia and England pre- and post-EMM implementation. 20 pharmacists were observed: 9 in an Australian 440-bed hospital (155 h); and 11 pharmacists in a 500-bed English hospital (258 h). The Work Observation Method By Activity Timing (WOMBAT) software was used to collect observational data. Proportions of observed time in 11 tasks by study period (pre- versus post-EMM) and site, time spent with others or alone, and using different tools (e.g computers, paper) were calculated. Magnitude of changes between pre- and post-EMM by task and country were determined using z-tests for proportions adjusting for multiple testing. RESULTS: At baseline, Australian and English pharmacists spent the greatest proportion of time in medication review. Post-EMM, time in medication review (Australia 21.6%-27.5%; England 27.1%-33.8%) and history-taking (Australia 7.6%-13.3%; England 19.5%-28.9%) significantly increased. Despite country differences in these tasks at baseline, the magnitude of changes did not significantly differ. English pharmacists increased time engaged in medication discussions with patients post-EMM (from 5.9% to 10.8%; p = 0.01). The Australian rate did not change (18.0%-27.2%; p = 0.09), but was higher at baseline. Post-EMM, Australian pharmacists spent 63.4% of time working alone, compared to 92.0% for English pharmacists. CONCLUSIONS: EMM systems impacted the same core areas of work and had a similar magnitude of effect on pharmacists' work in both countries. Anticipated reductions in medication review and history taking were not observed.

Application of Mixed Effects Limits of Agreement in the Presence of Multiple Sources of Variability: Exemplar from the Comparison of Several Devices to Measure Respiratory Rate in COPD Patients.

INTRODUCTION: The Bland-Altman limits of agreement method is widely used to assess how well the measurements produced by two raters, devices or systems agree with each other. However, mixed effects versions of the method which take into account multiple sources of variability are less well described in the literature. We address the practical challenges of applying mixed effects limits of agreement to the comparison of several devices to measure respiratory rate in patients with chronic obstructive pulmonary disease (COPD). METHODS: Respiratory rate was measured in 21 people with a range of severity of COPD. Participants were asked to perform eleven different activities representative of daily life during a laboratory-based standardised protocol of 57 minutes. A mixed effects limits of agreement method was used to assess the agreement of five commercially available monitors (Camera, Photoplethysmography (PPG), Impedance, Accelerometer, and Chest-band) with the current gold standard device for measuring respiratory rate. RESULTS: Results produced using mixed effects limits of agreement were compared to results from a fixed effects method based on analysis of variance (ANOVA) and were found to be similar. The Accelerometer and Chest-band devices produced the narrowest limits of agreement (-8.63 to 4.27 and -9.99 to 6.80 respectively) with mean bias -2.18 and -1.60 breaths per minute. These devices also had the lowest within-participant and overall standard deviations (3.23 and 3.29 for Accelerometer and 4.17 and 4.28 for Chest-band respectively). CONCLUSIONS: The mixed effects limits of agreement analysis enabled us to answer the question of which devices showed the strongest agreement with the gold standard device with respect to measuring respiratory rates. In particular, the estimated within-participant and overall standard deviations of the differences, which are easily obtainable from the mixed effects model results, gave a clear indication that the Accelerometer and Chest-band devices performed best.

Correction: Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial.

[This corrects the article DOI: 10.1371/journal.pmed.1002098.].

Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial.

BACKGROUND: Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes. METHODS AND FINDINGS: We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified between groups in weight, treatment pattern, adherence to medication, or quality of life in secondary analyses. There were few adverse events and these were equally distributed between the intervention and control groups. In secondary analysis, there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group (rate ratio 7.50 (95% CI 4.45-12.65, p < 0.0001) but no other significant differences between groups in use of health services were identified between groups. Key limitations include potential lack of representativeness of trial participants, inability to blind participants and health professionals, and uncertainty about the mechanism, the duration of the effect, and the optimal length of the intervention. CONCLUSIONS: Supported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 71674628.

Involving patients in clinical research: the Telescot Patient Panel.

BACKGROUND: To date, patient involvement in the development of clinical research work has been limited. In 2011, the Telescot research team commenced work on a feasibility trial to investigate home telemonitoring of blood pressure for people who have experienced stroke or transient ischaemic attack (TIA). The team decided to involve patients in the development of the research. OBJECTIVES: To improve research design through patient involvement. METHOD OF PATIENT INVOLVEMENT: A modified form of the 'Scrutiny Panel' approach was used to involve people who had stroke in the research project. RESULTS: The Patient Panel supported the research in three key ways: it informed patient communication; it presented patient perspectives on the applicability and usability of the intervention; and it guided the development of the qualitative study. DISCUSSION: The initiative was considered a positive experience for all. However, challenges were identified in terms of the time and cost implications of undertaking patient involvement. IMPLICATION FOR RESEARCH PRACTICE: Importance is attached to adequate project planning and development, partnership working with community-based organizations and the necessity for clear role delineation between patients and professionals to enable effective collaborative working. CONCLUSIONS: The Telescot Patient Panel was beneficial in supporting the development of the feasibility trial. The Panel approach was considered transferable to other clinical research contexts.

Qualitative study of telemonitoring of blood glucose and blood pressure in type 2 diabetes.

OBJECTIVES: To explore the experiences of patients and professionals taking part in a randomised controlled trial (RCT) of blood glucose, blood pressure (BP) and weight telemonitoring in type 2 diabetes supported by primary care, and identify factors facilitating or hindering the effectiveness of the intervention and those likely to influence its potential translation to routine practice. DESIGN: Qualitative study adopting an interpretive descriptive approach. PARTICIPANTS: 23 patients, 6 nurses and 4 doctors who were participating in a RCT of blood glucose and BP telemonitoring. A maximum variation sample of patients from within the trial based on age, sex and deprivation status of the practice was sought. SETTING: 12 primary care practices in Scotland and England. METHOD: Data were collected via recorded semistructured interviews. Analysis was inductive with themes presented within an overarching thematic framework. Multiple strategies were employed to ensure that the analysis was credible and trustworthy. RESULTS: Telemonitoring of blood glucose, BP and weight by people with type 2 diabetes was feasible. The data generated by telemonitoring supported self-care decisions and medical treatment decisions. Motivation to self-manage diet was increased by telemonitoring of blood glucose, and the 'benign policing' aspect of telemonitoring was considered by patients to be important. The convenience of home monitoring was very acceptable to patients although professionals had some concerns about telemonitoring increasing workload and costs. CONCLUSIONS: Telemonitoring of blood glucose, BP and weight in primary care is a promising way of improving diabetes management which would be highly acceptable to the type of patients who volunteered for this study. TRIAL REGISTRATION NUMBER: ISRCTN71674628; Pre-results.

Oximetry-supported self-management for chronic obstructive pulmonary disease: mixed method feasibility pilot project.

BACKGROUND: Pulse oximetry could potentially contribute to self-monitoring. NHS Lothian's 'Light Touch' service provided COPD patients with a self-management plan based on symptoms and oximetry. The service was overseen (though not actively monitored) by respiratory-trained community teams who were contactable by a telephone helpline. We aimed to assess the feasibility, perceived utility and impact of the 'Light Touch' service. METHODS: A before-and-after assessment of St George's Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Scale (HADS) and use of healthcare resources during the 6-month feasibility study compared to the previous corresponding 6-months. Paired semi-structured interviews with patients at baseline and 6-months, interviews with managers and a focus group of professionals explored perceptions of the service and self-management. Transcripts were coded, and analysed thematically. RESULTS: We recruited 51 participants (mean age 69.7 years (SD 8.4); 21 (46%) male). 46 participants completed quantitative follow up (2 died, 2 were unwell, 1 refused). SGRQ: 21 (46%) participants improved by 4 or more (the minimum important difference); 12 (26%) deteriorated by 4 or more. HADS: more participants had normal scores for anxiety (65%) and depression (80%) at 6-months than at baseline (51 and 64%). More emergency therapy was prescribed during the study period compared to the previous year. Only 18 participants (39%) contacted the Light Touch Helpline during the 6-month study. Twenty patients provided a total of 36 interviews, 8 clinicians contributed to a focus group and 6 managers were interviewed. Patients considered that the oximetry readings heightened awareness of their condition and gave them confidence to make self-management decisions. Healthcare professionals valued oximetry as a tool for teaching people self-management skills, but were concerned that patients rarely contacted the teams for help or advice during the study. CONCLUSIONS: 'Light Touch' shows promise as a low-cost strategy for empowering patients' self-management skills and reducing reliance on clinical supervision.

Mixed methods feasibility study for a trial of blood pressure telemonitoring for people who have had stroke/transient ischaemic attack (TIA).

BACKGROUND: Good blood pressure (BP) control reduces the risk of recurrence of stroke/transient ischaemic attack (TIA). Although there is strong evidence that BP telemonitoring helps achieve good control, none of the major trials have considered the effectiveness in stroke/TIA survivors. We therefore conducted a feasibility study for a trial of BP telemonitoring for stroke/TIA survivors with uncontrolled BP in primary care. METHOD: Phase 1 was a pilot trial involving 55 patients stratified by stroke/TIA randomised 3:1 to BP telemonitoring for 6 months or usual care. Phase 2 was a qualitative evaluation and comprised semi-structured interviews with 16 trial participants who received telemonitoring and 3 focus groups with 23 members of stroke support groups and 7 carers. RESULTS: Overall, 125 patients (60 stroke patients, 65 TIA patients) were approached and 55 (44%) patients were randomised including 27 stroke patients and 28 TIA patients. Fifty-two participants (95%) attended the 6-month follow-up appointment, but one declined the second daytime ambulatory blood pressure monitoring (ABPM) measurement resulting in a 93% completion rate for ABPM - the proposed primary outcome measure for a full trial. Adherence to telemonitoring was good; of the 40 participants who were telemonitoring, 38 continued to provide readings throughout the 6 months. There was a mean reduction of 10.1 mmHg in systolic ABPM in the telemonitoring group compared with 3.8 mmHg in the control group, which suggested the potential for a substantial effect from telemonitoring. Our qualitative analysis found that many stroke patients were concerned about their BP and telemonitoring increased their engagement, was easy, convenient and reassuring. CONCLUSIONS: A full-scale trial is feasible, likely to recruit well and have good rates of compliance and follow-up. TRIAL REGISTRATION: ISRCTN61528726 15/12/2011.

Telemonitoring for chronic obstructive pulmonary disease: a cost and cost-utility analysis of a randomised controlled trial.

We compared the costs and cost-effectiveness of telemonitoring vs usual care for patients with chronic obstructive pulmonary disease (COPD). A total of 256 patients were randomised to either telemonitoring or usual care. In the telemonitoring arm, the touch-screen telemonitoring equipment transmitted data to clinical teams monitoring the patients. Total healthcare costs were estimated over a 12-month period from a National Health Service perspective and quality adjusted life year (QALYs) were estimated by the EQ-5D tool. Telemonitoring was not significantly more costly than usual care (mean difference per patient £2065.90 (P < 0.18). The increased costs were predominantly due to telemonitoring service costs and non-significantly higher secondary care costs. Telemonitoring for COPD was not cost-effective at a base case of £137,277 per QALY with only 15% probability of being cost-effective at the usual threshold of £30,000 per QALY. Although there was some statistical and methodological uncertainty in the measures used, telemonitoring was not cost-effective in the sensitivity analyses performed. It seems unlikely that a telemonitoring service of the kind that was trialled would be cost-effective in providing care for people with COPD.

Effect of downsampling and compressive sensing on audio-based continuous cough monitoring.

This paper presents an efficient cough detection system based on simple decision-tree classification of spectral features from a smartphone audio signal. Preliminary evaluation on voluntary coughs shows that the system can achieve 98% sensitivity and 97.13% specificity when the audio signal is sampled at full rate. With this baseline system, we study possible efficiency optimisations by evaluating the effect of downsampling below the Nyquist rate and how the system performance at low sampling frequencies can be improved by incorporating compressive sensing reconstruction schemes. Our results show that undersampling down to 400 Hz can still keep sensitivity and specificity values above 90% despite of aliasing. Furthermore, the sparsity of cough signals in the time domain allows keeping performance figures close to 90% when sampling at 100 Hz using compressive sensing schemes.

The use of global positional satellite location in dementia: a feasibility study for a randomised controlled trial.

BACKGROUND: Getting lost outside is stressful for people with dementia and their caregivers and a leading cause of long-term institutionalisation. Although Global Positional Satellite (GPS) location has been promoted to facilitate safe walking, reduce caregivers' anxiety and enable people with dementia to remain at home, there is little high quality evidence about its acceptability, effectiveness or cost-effectiveness. This observational study explored the feasibility of recruiting and retaining participants, and the acceptability of outcome measures, to inform decisions about the feasibility of a randomised controlled trial (RCT). METHODS: People with dementia who had been provided with GPS devices by local social-care services and their caregivers were invited to participate in this study. We undertook interviews with people with dementia, caregivers and professionals to explore the perceived utility and challenges of GPS location, and assessed quality of life (QoL) and mental health. We piloted three methods of calculating resource use: caregiver diary; bi-monthly telephone questionnaires; and interrogation of health and social care records. We asked caregivers to estimate the time spent searching if participants became lost before and whilst using GPS. RESULTS: Twenty people were offered GPS locations services by social-care services during the 8-month recruitment period. Of these, 14 agreed to be referred to the research team, 12 of these participated and provided data. Eight people with dementia and 12 caregivers were interviewed. Most participants and professionals were very positive about using GPS. Only one person completed a diary. Resource use, anxiety and depression and QoL questionnaires were considered difficult and were therefore declined by some on follow-up. Social care records were time consuming to search and contained many omissions. Caregivers estimated that GPS reduced searching time although the accuracy of this was not objectively verified. CONCLUSIONS: Our data suggest that a RCT will face challenges not least that widespread enthusiasm for GPS among social-care staff may challenge recruitment and its ready availability may risk contamination of controls. Potential primary outcomes of a RCT should not rely on caregivers' recall or questionnaire completion. Time spent searching (if this could be accurately captured) and days until long-term admission are potentially suitable outcomes.

Telemonitoring for chronic heart failure: the views of patients and healthcare professionals - a qualitative study.

AIMS AND OBJECTIVES: To understand the views of patients and professionals on the acceptability and perceived usefulness of telemonitoring in the management of chronic heart failure in the context of day-to-day care provision. BACKGROUND: There is an increasing interest in the potential for telemonitoring to support the home-based management of patients with chronic heart failure. However, little is known about the views of patients and professionals on the use of telemonitoring in this context. A chronic heart failure telemonitoring service was set-up by NHS Lothian, Scotland, to evaluate the intervention. DESIGN: A qualitative design was adopted to explore the views of patients and professionals participating in the service. METHODS: Semi-structured interviews were undertaken with 18 patients (61% male, mean age 75 years) and five professionals participating at different time points in this new service. Interviews were audio recorded, coded and thematically analysed using the Framework approach. RESULTS: Five main themes were identified: 'information, support and reassurance'; 'compliance and dependence'; 'changes and challenges'; 'determining the criteria for patient applicability to telemonitoring'; and 'continuity of care'. CONCLUSION: Patients and professionals considered telemonitoring useful in the management of chronic heart failure, although with some caveats. Telemonitoring was popular with patients because they felt reassurance arising from what was perceived as continuous practitioner surveillance. Professionals expressed concern regarding perceived patient dependence on practitioner support. Increased workload was also a concern. Both groups acknowledged the need for improved technology and changes to service provision in order to better meet the intended objectives of the service. RELEVANCE TO CLINICAL PRACTICE: Although popular with patients, professionals emphasised the importance of case selection and adequate training and support, both for patients and themselves, in order to maximise the expected benefits of the service, particularly with regard to enabling self-management.

Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial.

OBJECTIVE: To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. DESIGN: Researcher blind, multicentre, randomised controlled trial. SETTING: UK primary care (Lothian, Scotland). PARTICIPANTS: Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. INTERVENTIONS: Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. MAIN OUTCOME MEASURES: The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George's respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. RESULTS: Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person (standard deviation 1.9) v control 1.1 (1.6); P=0.59). Mean duration of COPD admissions over one year was also similar between groups (9.5 days per person (standard deviation 19.1) v 8.8 days (15.9); P=0.88). The intervention had no significant effect on SGRQ scores between groups (68.2 (standard deviation 16.3) v 67.3 (17.3); adjusted mean difference 1.39 (95% confidence interval -1.57 to 4.35)), or on other questionnaire outcomes. Conclusions In participants with a history of admission for exacerbations of COPD, telemonitoring was not effective in postponing admissions and did not improve quality of life. The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication. TRIAL REGISTRATION: ISRCTN96634935. FUNDING: The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government (ARPG/07/03). The funder had no role in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. NHS Lothian supported the telemonitoring service and the clinical services.

The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial.

BACKGROUND: Diabetes prevalence is increasing and current methods of management are unsustainable. Effective approaches to supporting self-management are required. The aim of this randomized controlled trial is to establish whether supported telemetric monitoring of glycemic control and blood pressure results in reductions in glycosylated hemoglobin (HbA1c; the primary outcome of a measure of long-term glycemic control) and secondary outcomes of blood pressure and weight among people with poorly controlled diabetes compared to a control group receiving usual care. METHODS/DESIGN: Design: multi-center, randomized controlled trial with embedded qualitative study. Setting: primary care in Lothian, Kent, Glasgow and Borders regions in the UK. Participants: people with type 2 diabetes and confirmed HbA1c>7.5% (58 mmol/mol). Intervention/comparison: randomization to intervention or control groups will be performed by the Edinburgh Clinical Trials Unit. Participants in the intervention group will be shown how to use blood glucose and blood pressure monitors and weighing scales which use Bluetooth wireless technology to transmit readings via modem to a remote server. These participants will be asked to provide at least twice weekly measurements of morning and evening blood glucose and weekly measurements of weight and blood pressure. Measurements will be checked at least weekly by practice nurses who will contact the patients to adjust therapy according to guidelines and reinforce lifestyle advice. Participants in the control group will receive usual care. All participants will receive an individual education session. Follow-up: measurements will be performed at practices 9 months after randomization by research nurses blinded to allocation. The primary outcome measure is HbA1c and secondary outcomes measure are daytime systolic and diastolic blood pressure, weight and cost per quality-adjusted life year. Analysis: intention-to-treat analyses will be performed. The sample size of 320 participants allows for 20% drop-out and has 80% power at 5% significance to detect a 0.5% absolute (6 mmol/mol) fall in HbA1c in the intervention group. The qualitative study will explore the experiences of patients and professionals using the intervention. TRIAL REGISTRATION: Trial registration number ISRCTN71674628.

Exploring telemonitoring and self-management by patients with chronic obstructive pulmonary disease: a qualitative study embedded in a randomized controlled trial.

OBJECTIVE: To explore patient and professional views on self-management in the context of telemonitoring in chronic obstructive pulmonary disease (COPD). METHODS: Semi-structured interviews with patients with COPD and healthcare professionals participating in a randomized controlled trial of telemonitoring in Lothian, Scotland, explored experiences of using telemonitoring, and dynamics in patient-practitioner relationships. Transcribed data were analyzed using the Framework approach. RESULTS: 38 patients (mean age 67.5 years) and 32 professionals provided 70 interviews. Patients considered that telemonitoring empowered self-management by enhancing their understanding of COPD and providing additional justification for their decisions to adjust treatment or seek professional advice. Professionals discussed telemonitoring as promoting compliance with medical advice and encouraged patients to exercise personal responsibility within clinical parameters, but expressed concerns about promoting the sick role and creating dependence on telemonitoring. CONCLUSION: Telemonitoring assisted many patients to embrace greater responsibility for their health but the model of service provision remained clinician-centered. A medical model of 'compliant self-management' may paradoxically have promoted dependence on professionals. PRACTICE IMPLICATIONS: Patients and professionals shared responsibility for meeting the central objective of prompt management of exacerbations of COPD. Care is needed, however, to minimize the risk in some patients, of telemonitoring increasing dependence on practitioner support.

Continuity, but at what cost? The impact of telemonitoring COPD on continuities of care: a qualitative study.

BACKGROUND: Continuity of care is widely regarded as an important marker of quality in the management of patients with long-term conditions. New services that integrate telemonitoring into care pathways have potential to change aspects of continuity in both positive and negative ways. AIMS: A telemonitoring service for patients with chronic obstructive pulmonary disease (COPD) was introduced in Lothian, Scotland, in 2009. A qualitative study, nested within the TELESCOT COPD randomised control trial, was undertaken to explore the views of patients and professionals on telemonitoring. The perceived impact of telemonitoring on continuity of care was investigated as part of the research. METHODS: Semi-structured interviews were undertaken with 38 patients (47% male, mean age 67.5 years). A maximum variation sample in relation to age, sex, socio-economic background, disease severity, and compliance with telemonitoring was recruited. Thirty-two stakeholders (healthcare professionals and managers) were interviewed. Transcribed coded data were analysed thematically using the framework approach. Interpretation was supported by multidisciplinary discussion. RESULTS: Patients and healthcare professionals considered that relationship-based continuity of care was important in the delivery of telemonitoring services. Managers placed emphasis on improved continuity of clinical management as a means of reducing healthcare costs. However, professionals described many operational challenges arising from the 'bolting-on' of telemonitoring provision to existing usual care provision which, they considered, resulted in the proliferation of additional managerial discontinuities. CONCLUSIONS: Managers and healthcare professionals face major challenges in meeting demands for both relationship continuity and continuity of clinical management in the development of telemonitoring services.

Front desk talk: discourse analysis of receptionist-patient interaction.

BACKGROUND: GP receptionists are the first point of contact with the NHS for most patients and have an important role in facilitating access to healthcare services. There is evidence that they are often perceived as impersonal, insensitive, or officious. AIM: To analyse the communicative styles of GP receptionists when dealing with patients. DESIGN OF STUDY: Ethnographically situated discourse analysis of audio recordings. SETTING: Three NHS GP surgeries in Scotland. METHOD: Fine-grained transcription and stage-by-stage analysis of digital audio recordings of 283 encounters between receptionists and patients engaged in front desk business. Participants were 16 receptionists and 283 patients. RESULTS: Interaction between receptionists and patients consists mainly of verbal routines that are shaped by the administrative tasks completed through them. Receptionists adhere to these established patterns of use at all times, even when dealing with non-routine situations. Within the routine framework, receptionists communicate with patients using styles that display three dominant approaches: task centred, conventionally polite, and rapport building. Receptionists who adopt a task-centred approach use forms with minimal interpersonal content, while those who use conventionally polite forms or those associated with rapport building, give attention to establishing positive relationships with patients. There is no evidence that any stylistic approach is more efficient than another. There is, however, evidence that excessive adherence to routine verbal behaviour has an adverse impact on problem solving. CONCLUSION: Most receptionist discourse consists of the repetition of established verbal routines. Receptionists adopt verbal styles that are predominantly task centred, conventionally polite, or rapport building. Although all three styles enable the completion of reception work with similar levels of efficiency, task-centred styles may appear over-direct. The use of a routine approach when dealing with problematic situations can inhibit and delay their resolution.

Impact on hypertension control of a patient-held guideline: a randomised controlled trial.

BACKGROUND: Hypertension is generally poorly controlled in primary care. One possible intervention for improving control is the harnessing of patient expertise through education and encouragement to challenge their care. AIM: To determine whether encouraging patients to manage their hypertension in an 'expert' manner, by providing them with information in a clear clinical guideline, coupled with an explicit exhortation to become involved in and to challenge their own care if appropriate, would improve their care. DESIGN OF STUDY: Single blind randomised controlled trial of detailed guideline versus standard information. SETTING: Single urban general practice over 1 year. METHOD: Patient-held guideline with written explicit exhortation to challenge care when appropriate. Two hundred and ninety-four of 536 eligible patients on the practice hypertension register were recruited, all of whom were randomised into one of two groups. Two hundred and thirty-six patients completed the study. PRIMARY OUTCOME: average systolic blood pressure. SECONDARY OUTCOMES: proportion of patients with blood pressure < 150 mmHg systolic and < 90 mmHg diastolic, average cholesterol, proportion of patients prescribed statins and aspirin according to guideline, hospital anxiety and depression score. No clinically, or statistically significant differences were found between intervention and control with respect to all parameters or in anxiety and depression levels. Statin and aspirin use improved throughout the course of the study in both groups. Statin use showed a trend (P = 0.02) in favour of control. CONCLUSION: In this study there was no clinically significant perceived benefit to patients as a result of providing them with a hypertension guideline. Patient guidelines are currently planned for many chronic illnesses. It is important to determine the utility of such interventions before scarce resources are applied to them.