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1.  Effect of telecare on use of health and social care services: findings from the Whole Systems Demonstrator cluster randomised trial 
Age and Ageing  2013;42(4):501-508.
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.
doi:10.1093/ageing/aft008
PMCID: PMC3684109  PMID: 23443509
telecare; assistive technology; randomised controlled trial; administrative data; older people
2.  Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: a qualitative study 
Background
Telehealth (TH) and telecare (TC) interventions are increasingly valued for supporting self-care in ageing populations; however, evaluation studies often report high rates of non-participation that are not well understood. This paper reports from a qualitative study nested within a large randomised controlled trial in the UK: the Whole System Demonstrator (WSD) project. It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial.
Methods
Qualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention (n = 19), or who withdrew from the intervention arm (n = 3). Participants were recruited from the four trial groups (with diabetes, chronic obstructive pulmonary disease, heart failure, or social care needs); and all came from the three trial areas (Cornwall, Kent, east London). Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home. Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes.
Results
Barriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes: requirements for technical competence and operation of equipment; threats to identity, independence and self-care; expectations and experiences of disruption to services. Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderstandings. Respondents’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance, and views that interventions could undermine self-care and coping. Finally, participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued.
Conclusions
These findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake. These insights have implications for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction. It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation.
doi:10.1186/1472-6963-12-220
PMCID: PMC3413558  PMID: 22834978
Telehealth; Telecare; Patients’ perspectives; Non-adoption; Non-participation; Barriers; Qualitative research; Whole System Demonstrator
3.  The effect of Telehealth on disease-specific quality of life in patients with heart failure: the Whole Systems Demonstrator Telehealth Questionnaire Study 
Introduction
Primary studies and systematic reviews that have examined the effect of Telehealth (TH) on Health-Related Quality of Life (HRQoL) typically conclude that TH leads to quality of life improvements. The evidence base on which such conclusions rest is characterised by methodologically weak studies that generate equivocal findings. The effectiveness of TH, in terms of quality of life benefits, has yet to be substantiated in high-quality trials.
Aims
Using data from the WSD Telehealth Questionnaire Study we assessed the impact of TH on disease-specific HRQoL, generic HRQoL and psychological outcomes (anxiety and depression) in patients with heart failure, over a 12-month period.
Design
The WSD Telehealth Questionnaire Study is pragmatic cluster-randomised controlled trial evaluating a broad range of patient-reported outcome measures. Participants were recruited from three Sites in the UK (Cornwall, Kent and Newham). The current analyses focus on participants with heart failure.
Methods
Over 500 participants with heart failure completed measures of disease-specific HRQoL (MLHFQ), generic HRQoL (UK SF-12; EQ5D), anxiety (Brief STAI) and depression (CESD-10) at baseline. Follow-up assessments were conducted at 4 and 12 months.
Results
Primary and sensitivity analyses will be presented for the heart failure cohort and interpreted in light of existing WSD findings that examine generic HRQoL in a pooled clinical sample comprising participants with heart failure, COPD and diabetes. Specific findings from the WSD Telehealth Questionnaire Study are embargoed until these analyses have been peer-reviewed and accepted for publication.
Conclusions
Conclusions cannot be released until the analyses have been peer-reviewed and accepted for publication.
PMCID: PMC3571121
telehealth; heart failure; quality of life; Whole System Demonstrator
4.  A pragmatic cluster randomised controlled trial of telehealth on disease specific quality of life in patients’ with chronic obstructive pulmonary disease and their health-related quality of life and psychological distress over 1 year in the Whole System Demonstrator programme 
Introduction
There is limited evidence for the effectiveness of TH on quality of life (QoL) in patients with COPD. A systematic review in the area inclusive of all respiratory conditions indicated that there were no UK based studies, or randomised controlled trials (RCTs) evaluating the effectiveness of TH for COPD (Janna et al. 2009). A more recent systematic review found 6 studies, only two of which measured QoL as an outcome (Bolton et al. 2010). One of these studies was a RCT and found improvements in QoL at 3 months (Koff 2009), while the other was a non-controlled before and after study which found no difference in quality of life scores at 6 months (Trappenburg, 2008). Research in this area is plagued by small sample sizes, absence of longer-term follow-ups, insufficient descriptions of the intervention, poor internal validity of whether using the device in the context of a complex healthcare intervention leads to improved outcomes for the patient, and few attempts to measure quality of life in patients with COPD following the introduction of these devices.
Aims and objectives
The current investigation is part of the Whole System Demonstrator (WSD) programme that aims to evaluate the effectiveness of telehealth (TH) for patient reported outcomes with Chronic Obstructive Pulmonary Disease (COPD). The primary objective was to evaluate the effectiveness of telehealth for COPD specific QoL and to examine whether there were improvements in HRQoL and psychological distress at short-term and long-term follow-up in this cohort of patients with COPD.
Methods
WSD is one of the largest pragmatic cluster randomised controlled trials evaluating TH in the UK. Patients with COPD from three regions in England (Cornwall, Kent and Newham) were recruited from 179 GP practices randomised balancing for region, practice size, deprivation index, non-white proportion and prevalence of COPD. Over 570 patients with COPD completed a comprehensive battery of questionnaires assessing a range of patient reported outcomes. Measures of generic Health-Related Quality of Life (HRQoL) (Short Form-12), disease specific QoL including perceived control over COPD, fatigue caused by the disease and the emotional impact of the disease (Chronic Respiratory Questionnaire). Psychological distress was measured by depression (CESD-10) and anxiety (STAI).
Results
Multi-level modelling was utilised to evaluate the effect of trial arm on HRQoL and COPD specific QoL. Results for intention-to-treat analysis, participants that received the intervention as per the research protocol, complete case analysis for cases with all baseline, short-term and longer-term follow-ups completed and an available case analysis of patients with either a short or long-term follow-up available. The results will be discussed and have important clinical implications for COPD management.
Conclusions
Results and conclusions are censored until any findings are published in peer-reviewed journals.
PMCID: PMC3571149
telehealth; COPD; Quality of life; Whole System Demonstrator
5.  The impact on carers of individuals with social care needs: the Whole Systems Demonstrator study 
Introduction
Carers of individuals with social care needs (including frail elderly people, those at risk of falls and those requiring night sitting), are subject to high levels of carer burden, social isolation and poor psychological outcomes. Carers’ worries and concerns include leaving the individual alone; risks of harm to the care-recipient; or household emergencies in their absence. At present there is a lack of research on the impact of telecare interventions on carer outcomes. It is feasible that carers’ anxieties and level of strain may be ameliorated with concomitant increases in quality of life, with the introduction of telecare systems for their care-recipient.
Objectives
This study investigates the secondary impact of telecare on carers, specifically whether the use of telecare reduces informal carer burden and social isolation and whether it improves carers’ psychological well-being and confidence in leaving the care-recipient alone.
Design
We report on the prospective analysis of a pragmatic controlled trial on carers of telecare users and controls within the WSD evaluation of telecare (a pragmatic cluster randomised controlled trial investigating the effectiveness of telecare for social care recipients).
Methods
Carers of individuals with social care needs were identified and recruited to the study via a combination of snowball sampling, light touch visits (to users) and self selection. Over 200 carers completed a questionnaire pack at baseline, and at short and long-term follow-ups; with roughly equal numbers of carers of recipients of telecare and recipients of usual care. The questionnaire pack included measures of quality of life (ICECAP), health related quality of life (SF12, EQ5D), psychosocial well-being (STAI-6, CESD10) and care-giver strain measures (CGSI, Carer confidence and anxiety).
Results and Conclusions
Multi-level modelling of difference in outcomes between carer groups and across time was conducted with appropriate covariates. Specific findings from the Telecare Carers Study are embargoed until these analyses have been peer-reviewed and accepted for publication.
PMCID: PMC3571154
carers; telecare; quality of life; carer outcomes; social care needs
6.  Exploring the impact of a Tele-health intervention on specific quality of life domains and psychological well-being in diabetic patients within the Whole Systems Demonstrator Questionnaire Study 
Introduction
Much is written about the promise of Telehealth (TH) and there is great enthusiasm about its potential. However, many studies of TH do not meet orthodox quality standards. Evidence-based on assimilating findings from a few small trials of variable methodological quality presents equivocal findings and makes results difficult to interpret. Robust evidence to inform policy decisions is considered to be lacking (Ekeland et al., 2010). This remains the case when specific long-term conditions such as diabetes are considered with regards to health related quality of life (HRQoL) outcomes. The WSD study aimed to address some of these concerns.
Aims
This study investigated the impact of TH on disease-specific HRQoL, generic HRQoL and psychological outcomes (anxiety and depression) in patients with diabetes, utilising longitudinal questionnaire data from the WSD Telehealth Study.
Design
The WSD Telehealth Questionnaire Study is pragmatic cluster-randomised controlled trial evaluating a broad range of patient-reported outcome measures. Participants were recruited from three sites in the UK (Cornwall, Kent and Newham). The current analyses focus on participants with diabetes.
Methods
Over 400 participants with diabetes completed measures of disease-specific HRQoL (DHP), generic HRQoL (UK SF-12; EQ5D), anxiety (Brief STAI) and depression (CESD-10) at baseline. Short- and long-term follow-up assessments were conducted. Multi-level modelling analyses of difference in outcomes between trial arm groups and across time were conducted with appropriate covariates.
Results and Conclusions
Findings and conclusions from the WSD Telehealth Study are embargoed until these analyses have been peer-reviewed and accepted for publication.
PMCID: PMC3571160
telehealth; diabetes; quality of life; psychological outcomes; Whole System Demonstrator
7.  Cost-effectiveness of telehealth in people with social care needs: the Whole Systems Demonstrator cluster randomised trial 
Introduction
The Whole Systems Demonstrator pilots introduced telehealth and telecare into three local authority areas using an integrated approach to deliver health and social care to those with high care needs and long-term conditions. Proponents of these technologies have given cost savings as one rationale for advocating their introduction and widespread implementation; proponents have also advocated their potential to improve the quality of life for their users. Until recently, evaluations of telehealth and telecare in high-income countries have been based on relatively small-scale pilots; few such evaluations have been designed as randomised controlled trials. The WSD study was a pragmatic cluster-randomised control trial, representing the largest-scale trial of telehealth and telecare to be carried out in the UK. This presentation focuses on the results of the WSD telecare questionnaire study.
Objectives
To examine the costs and cost-effectiveness of telecare compared to standard support and treatment.
Methods
Economic evaluation conducted in parallel with a pragmatic cluster-randomised controlled trial of Telecare. 2600 people with social care needs participated in a trial of a community-based telecare intervention in three English local authority areas. Approximately half of the participants in the telecare trial also consented to participate in the WSD telecare questionnaire study, which collected information on a number of patient-reported outcome measures and also on the self-reported use of a range of health and social services. Health and social costs were calculated by attaching nationally applicable unit costs to self-reported service use data. The unit costs of telecare support and treatment provided were calculated drawing on administrative and financial data sources and interviews with key informants. The primary outcome for the cost-effectiveness analysis was the quality-adjusted life year (QALY). Secondary outcomes included measures of health-related quality of life and well-being. We employed multivariate analyses to explore the cost-effectiveness of the intervention
Results
The presentation will describe the results of the economic evaluation of telecare, addressing the cost of care and treatment packages used by those participating in the telecare questionnaire study and the results of the cost-effectiveness analysis. These results will be available by the time of the presentation.
Conclusions
These will be available by the time of the presentation.
PMCID: PMC3571183
economic evaluation; social care; cost analysis; telecare
8.  A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial 
Background
It is expected that increased demands on services will result from expanding numbers of older people with long-term conditions and social care needs. There is significant interest in the potential for technology to reduce utilisation of health services in these patient populations, including telecare (the remote, automatic and passive monitoring of changes in an individual's condition or lifestyle) and telehealth (the remote exchange of data between a patient and health care professional). The potential of telehealth and telecare technology to improve care and reduce costs is limited by a lack of rigorous evidence of actual impact.
Methods/Design
We are conducting a large scale, multi-site study of the implementation, impact and acceptability of these new technologies. A major part of the evaluation is a cluster-randomised controlled trial of telehealth and telecare versus usual care in patients with long-term conditions or social care needs. The trial involves a number of outcomes, including health care utilisation and quality of life. We describe the broad evaluation and the methods of the cluster randomised trial
Discussion
If telehealth and telecare technology proves effective, it will provide additional options for health services worldwide to deliver care for populations with high levels of need.
Trial Registration
Current Controlled Trials ISRCTN43002091
doi:10.1186/1472-6963-11-184
PMCID: PMC3169462  PMID: 21819569
9.  Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial 
Objective To assess the effect of home based telehealth interventions on the use of secondary healthcare and mortality.
Design Pragmatic, multisite, cluster randomised trial comparing telehealth with usual care, using data from routine administrative datasets. General practice was the unit of randomisation. We allocated practices using a minimisation algorithm, and did analyses by intention to treat.
Setting 179 general practices in three areas in England.
Participants 3230 people with diabetes, chronic obstructive pulmonary disease, or heart failure recruited from practices between May 2008 and November 2009.
Interventions Telehealth involved remote exchange of data between patients and healthcare professionals as part of patients’ diagnosis and management. Usual care reflected the range of services available in the trial sites, excluding telehealth.
Main outcome measure Proportion of patients admitted to hospital during 12 month trial period.
Results Patient characteristics were similar at baseline. Compared with controls, the intervention group had a lower admission proportion within 12 month follow-up (odds ratio 0.82, 95% confidence interval 0.70 to 0.97, P=0.017). Mortality at 12 months was also lower for intervention patients than for controls (4.6% v 8.3%; odds ratio 0.54, 0.39 to 0.75, P<0.001). These differences in admissions and mortality remained significant after adjustment. The mean number of emergency admissions per head also differed between groups (crude rates, intervention 0.54 v control 0.68); these changes were significant in unadjusted comparisons (incidence rate ratio 0.81, 0.65 to 1.00, P=0.046) and after adjusting for a predictive risk score, but not after adjusting for baseline characteristics. Length of hospital stay was shorter for intervention patients than for controls (mean bed days per head 4.87 v 5.68; geometric mean difference −0.64 days, −1.14 to −0.10, P=0.023, which remained significant after adjustment). Observed differences in other forms of hospital use, including notional costs, were not significant in general. Differences in emergency admissions were greatest at the beginning of the trial, during which we observed a particularly large increase for the control group.
Conclusions Telehealth is associated with lower mortality and emergency admission rates. The reasons for the short term increases in admissions for the control group are not clear, but the trial recruitment processes could have had an effect.
Trial registration number International Standard Randomised Controlled Trial Number Register ISRCTN43002091.
doi:10.1136/bmj.e3874
PMCID: PMC3381047  PMID: 22723612
10.  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  
Objective 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.
Setting Provision of primary and secondary care via general practices, specialist nurses, and hospital clinics in three diverse regions of England (Cornwall, Kent, and Newham), with established integrated health and social care systems.
Participants Patients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009.
Main outcome measures Generic, 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).
Results In 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 effective or efficacious compared with usual care only. Telehealth did not improve quality of life or psychological outcomes for patients with chronic obstructive pulmonary disease, diabetes, or heart failure over 12 months. The findings suggest that concerns about potentially deleterious effect of telehealth are unfounded for most patients.
Trial Registration ISRCTN43002091.
doi:10.1136/bmj.f653
PMCID: PMC3582704  PMID: 23444424

Results 1-10 (10)