Objective To examine the costs and cost effectiveness of telehealth in addition to standard support and treatment, compared with standard support and treatment.Design Economic evaluation nested in a pragmatic, cluster randomised controlled trial.Setting Community based telehealth intervention in three local authority areas in England.Participants 3230 people with a long term condition (heart failure, chronic obstructive pulmonary disease, or diabetes) were recruited into the Whole Systems Demonstrator telehealth trial between May 2008 and December 2009. Of participants taking part in the Whole Systems Demonstrator telehealth questionnaire study examining acceptability, effectiveness, and cost effectiveness, 845 were randomised to telehealth and 728 to usual care.Interventions Intervention participants received a package of telehealth equipment and monitoring services for 12 months, in addition to the standard health and social care services available in their area. Controls received usual health and social care.Main outcome measure Primary outcome for the cost effectiveness analysis was incremental cost per quality adjusted life year (QALY) gained. ResultsWe undertook net benefit analyses of costs and outcomes for 965 patients (534 receiving telehealth; 431 usual care). The adjusted mean difference in QALY gain between groups at 12 months was 0.012. Total health and social care costs (including direct costs of the intervention) for the three months before 12 month interview were £1390 (€1610; $2150) and £1596 for the usual care and telehealth groups, respectively. Cost effectiveness acceptability curves were generated to examine decision uncertainty in the analysis surrounding the value of RESEARCHthe cost effectiveness threshold. The incremental cost per QALY of telehealth when added to usual care was £92 000. With this amount, the probability of cost effectiveness was low (11% at willingness to pay threshold of £30 000; >50% only if the threshold exceeded about £90 000). In sensitivity analyses, telehealth costs remained slightly (non-significantly) higher than usual care costs, even after assuming that equipment prices fell by 80% or telehealth services operated at maximum capacity. However, the most optimistic scenario (combining reduced equipment prices with maximum operating capacity) eliminated this group difference (cost effectiveness ratio £12 000 per QALY). ConclusionsThe QALY gain by patients using telehealth in addition to usual care was similar to that by patients receiving usual care only, and total costs associated with the telehealth intervention were higher. Telehealth does not seem to be a cost effective addition to standard support and treatment.Trial registration ISRCTN43002091.

Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial AbstractObjective To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions.Design A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care. Data were collected at baseline, four months (short term), and 12 months (long term). Primary intention to treat analyses tested treatment effectiveness; multilevel models controlled for clustering by general practice and a range of covariates. Analyses were conducted for 759 participants who completed questionnaire measures at all three time points (complete case cohort) and 1201 who completed the baseline assessment plus at least one other assessment (available case cohort). Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts, respectively.Correspondence to: S P Newman stanton.newman.1@city.ac.uk Extra material supplied by the author (see http://www.bmj.com/content/346/bmj.f653?tab=related#webextra)Web appendix 1: Whole Systems Demonstrator (WSD) terminology Web appendix 2: Description of the telehealth intervention Web appendix 3: Per protocol criteria Web figure 1: Provision of peripheral telehealth devices to intervention participants in the WSD Telehealth Questionnaire Study Web figure 2: Early removal of telehealth for reasons other than death across the 12 month trial period Web Main outcome measuresGeneric, health related quality of life (assessed by physical and mental health component scores of the SF-12, and the EQ-5D), anxiety (assessed by the six item Brief State-Trait Anxiety Inventory), and depressive symptoms (assessed by the 10 item Centre for Epidemiological Studies Depression Scale). ResultsIn the intention to treat analyses, differences between treatment groups were small and non-significant for all outcomes in the complete case (0.480≤P≤0.904) or available case (0.181≤P≤0.905) cohorts. The magnitude of differences between trial arms did not reach the trial defined, minimal clinically important difference (0.3 standardised mean difference) for any outcome in either cohort at four or 12 months. Per protocol analyses replicated the primary analyses; the main effect of trial arm (telehealth v usual care) was non-significant for any outcome (complete case cohort 0.273≤P≤0.761; available case cohort 0.145≤P≤0.696).Conclusions Second generation, home based telehealth as implemented in the Whole Systems Demonstrator Evaluation was not e...

Introduction: Telehealth (TH) is a potential solution to the increased incidence of chronic illness in an ageing population.The extent to which older people and users with chronic conditions accept and adhere to using assistive technologies is a potential barrier to mainstreaming the service. This study reports the development and validation of the Whole Systems Demonstrator (WSD) Service User Technology Acceptability Questionnaire (SUTAQ). Methods:Questionnaires measuring the acceptability of TH, quality of life, well-being and psychological processes were completed by 478 users of TH. The 22 acceptability items were subject to principal components analysis (PCA) to determine sub-scales. Scale scores, relationships between scales and other patient reported outcome measures (PROMs), and group differences on scales were utilised to check the reliability and validity of the measure.Results: PCAs of SUTAQ items produced 6 TH acceptability scales: enhanced care, increased accessibility, privacy & discomfort, care personnel concerns, kit as substitution, and satisfaction. Scale scores indicated, individuals with long term conditions held beliefs.Significant correlations within these beliefs and between these scales and additional PROMs were coherent and the SUTAQ subscales were able to predict those more likely to refuse TH.2 Discussion: The SUTAQ is an instrument that can be used to measure user beliefs about the acceptability of TH, and has the ability to discriminate and predict individual differences in beliefs and behaviour. Measuring acceptability beliefs of TH users can provide valuable information to direct and target provision of services to increase uptake and maintain use of TH. IntroductionA TH service allows healthcare professionals (HCP) to monitor patients' condition remotely and enables the patient to receive remote care from the comfort of their homes and where appropriate direct healthcare intervention in a timely manner. Patients are provided with kit appropriate to their condition that require users to measure vital signs (e.g. blood pressure, blood glucose, blood oxygen levels). These readings are electronically sent back to HCPs, who via computerised algorithms and professional experience, examine changes in the patients conditions and take action if necessary including direct response to the patient. (1)). The monitoring system defined above has been referred to with different terms within the literature (e.g. telecare, telemonitoring, telemedicine), but we use the term TH as defined within the Whole Systems Demonstrator (WSD) Telehealth study (3).TH aims to reduce the burden upon the healthcare system through reducing the rates of high cost services, reducing travel costs and identifying potential problems early before they become serious medical episodes (2). Furthermore from the patient perspective TH also can be perceived as increasing access to services, a means of reducing health concerns, and a tool enable them be more actively involved in their health care (3).One potential obst...

Objective: to assess the impact of telecare on the use of social and health care. Part of the evaluation of the Whole Systems Demonstrator trial.Participants and setting: a total of 2,600 people with social care needs were recruited from 217 general practices in three areas in England.Design: a cluster randomised trial comparing telecare with usual care, general practice being the unit of randomisation. Participants were followed up for 12 months and analyses were conducted as intention-to-treat.Data sources: trial data were linked at the person level to administrative data sets on care funded at least in part by local authorities or the National Health Service.Main outcome measures: the proportion of people admitted to hospital within 12 months. Secondary endpoints included mortality, rates of secondary care use (seven different metrics), contacts with general practitioners and practice nurses, proportion of people admitted to permanent residential or nursing care, weeks in domiciliary social care and notional costs.Results: 46.8% of intervention participants were admitted to hospital, compared with 49.2% of controls. Unadjusted differences were not statistically significant (odds ratio: 0.90, 95% CI: 0.75–1.07, P = 0.211). They reached statistical significance after adjusting for baseline covariates, but this was not replicated when adjusting for the predictive risk score. Secondary metrics including impacts on social care use were not statistically significant.Conclusions: telecare as implemented in the Whole Systems Demonstrator trial did not lead to significant reductions in service use, at least in terms of results assessed over 12 months.International Standard Randomised Controlled Trial Number Register ISRCTN43002091.

SummaryBackgroundGraded exercise therapy is an effective and safe treatment for chronic fatigue syndrome, but it is therapist intensive and availability is limited. We aimed to test the efficacy and safety of graded exercise delivered as guided self-help.MethodsIn this pragmatic randomised controlled trial, we recruited adult patients (18 years and older) who met the UK National Institute for Health and Care Excellence criteria for chronic fatigue syndrome from two secondary-care clinics in the UK. Patients were randomly assigned to receive specialist medical care (SMC) alone (control group) or SMC with additional guided graded exercise self-help (GES). Block randomisation (randomly varying block sizes) was done at the level of the individual with a computer-generated sequence and was stratified by centre, depression score, and severity of physical disability. Patients and physiotherapists were necessarily unmasked from intervention assignment; the statistician was masked from intervention assignment. SMC was delivered by specialist doctors but was not standardised; GES consisted of a self-help booklet describing a six-step graded exercise programme that would take roughly 12 weeks to complete, and up to four guidance sessions with a physiotherapist over 8 weeks (maximum 90 min in total). Primary outcomes were fatigue (measured by the Chalder Fatigue Questionnaire) and physical function (assessed by the Short Form-36 physical function subscale); both were self-rated by patients at 12 weeks after randomisation and analysed in all randomised patients with outcome data at follow-up (ie, by modified intention to treat). We recorded adverse events, including serious adverse reactions to trial interventions. We used multiple linear regression analysis to compare SMC with GES, adjusting for baseline and stratification factors. This trial is registered at ISRCTN, number ISRCTN22975026.FindingsBetween May 15, 2012, and Dec 24, 2014, we recruited 211 eligible patients, of whom 107 were assigned to the GES group and 104 to the control group. At 12 weeks, compared with the control group, mean fatigue score was 19·1 (SD 7·6) in the GES group and 22·9 (6·9) in the control group (adjusted difference −4·2 points, 95% CI −6·1 to −2·3, p<0·0001; effect size 0·53) and mean physical function score was 55·7 (23·3) in the GES group and 50·8 (25·3) in the control group (adjusted difference 6·3 points, 1·8 to 10·8, p=0·006; 0·20). No serious adverse reactions were recorded and other safety measures did not differ between the groups, after allowing for missing data.InterpretationGES is a safe intervention that might reduce fatigue and, to a lesser extent, physical disability for patients with chronic fatigue syndrome. These findings need confirmation and extension to other health-care settings.FundingUK National Institute for Health Research Research for Patient Benefit Programme and the Sue Estermann Fund.