Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Bower P

PROVIDER: S-EPMC3169462 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

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Publications

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.

Bower Peter P Cartwright Martin M Hirani Shashivadan P SP Barlow James J Hendy Jane J Knapp Martin M Henderson Catherine C Rogers Anne A Sanders Caroline C Bardsley Martin M Steventon Adam A Fitzpatrick Raymond R Doll Helen H Newman Stanton S

BMC health services research 20110805

<h4>Background</h4>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 p ...[more]

PMID: 21819569

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Project description:BackgroundTelehealth is increasingly used in the care of people with long term conditions. Whilst many studies look at the impacts of the technology on hospital use, few look at how it changes contacts with primary care professionals. The aim of this paper was to assess the impacts of home-based telehealth interventions on general practice contacts.MethodSecondary analysis of data from a Department of Health funded cluster-randomised trial with 179 general practices in three areas of England randomly assigned to offer telehealth or usual care to eligible patients. Telehealth included remote exchange of vitals signs and symptoms data between patients and healthcare professionals as part of the continuing management of patients. Usual care reflected the range of services otherwise available in the sites, excluding telehealth. Anonymised data from GP systems were used to construct person level histories for control and intervention patients. We tested for differences in numbers of general practitioner and practice nurse contacts over twelve months and in the number of clinical readings recorded on general practice systems over twelve months.Results3,230 people with diabetes, chronic obstructive pulmonary disease or heart failure were recruited in 2008 and 2009. 1219 intervention and 1098 control cases were available for analysis. No statistically significant differences were detected in the numbers of general practitioner or practice nurse contacts between intervention and control groups during the trial, or in the numbers of clinical readings recorded on the general practice systems.ConclusionsTelehealth did not appear associated with different levels of contact with general practitioners and practice nurses. We note that the way that telehealth impacts on primary care roles may be influenced by a number of other features in the health system. The challenge is to ensure that these systems lead to better integration of care than fragmentation.Trial registration numberInternational Standard Randomised Controlled Trial Number Register ISRCTN43002091.

Project description:BACKGROUND: The Whole Systems Demonstrator was a large, pragmatic, cluster randomised trial that compared telehealth with usual care among 3,230 patients with long-term conditions in three areas of England. Telehealth involved the regular transmission of physiological information such as blood glucose to health professionals working remotely. We examined whether telehealth led to changes in glycosylated haemoglobin (HbA1c) among the subset of patients with type 2 diabetes. METHODS: The general practice electronic medical record was used as the source of information on HbA1c. Effects on HbA1c were assessed using a repeated measures model that included all HbA1c readings recorded during the 12-month trial period, and adjusted for differences in HbA1c readings recorded before recruitment. Secondary analysis averaged multiple HbA1c readings recorded for each individual during the trial period. RESULTS: 513 of the 3,230 participants were identified as having type 2 diabetes and thus were included in the study. Telehealth was associated with lower HbA1c than usual care during the trial period (difference 0.21% or 2.3 mmol/mol, 95% CI, 0.04% to 0.38%, p = 0.013). Among the 457 patients in the secondary analysis, mean HbA1c showed little change for controls following recruitment, but fell for intervention patients from 8.38% to 8.15% (68 to 66 mmol/mol). A higher proportion of intervention patients than controls had HbA1c below the 7.5% (58 mmol/mol) threshold that was targeted by general practices (30.4% vs. 38.0%). This difference, however, did not quite reach statistical significance (adjusted odds ratio 1.63, 95% CI, 0.99 to 2.68, p = 0.053). CONCLUSIONS: Telehealth modestly improved glycaemic control in patients with type 2 diabetes over 12 months. The scale of the improvements is consistent with previous meta-analyses, but was relatively modest and seems unlikely to produce significant patient benefit. TRIAL REGISTRATION NUMBER: International Standard Randomized Controlled Trial Number Register ISRCTN43002091.

Project description:ObjectiveTo 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.DesignA 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.SettingProvision 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.ParticipantsPatients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009.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).ConclusionsSecond 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 registrationISRCTN43002091.

Project description:BackgroundMuch is written about the promise of telehealth and there is great enthusiasm about its potential. However, many studies of telehealth do not meet orthodox quality standards and there are few studies examining quality of life in diabetes as an outcome.Objective To assess the impact of home-based telehealth (remote monitoring of physiological, symptom and self-care behavior data for long-term conditions) on generic and disease-specific health-related quality of life, anxiety, and depressive symptoms over 12 months in patients with diabetes. Remote monitoring provides the potential to improve quality of life, through the reassurance it provides patients.MethodsThe study focused on participant-reported outcomes of patients with diabetes within the Whole Systems Demonstrator (WSD) Telehealth Questionnaire Study, nested within a pragmatic cluster-randomized trial of telehealth (the WSD Telehealth Trial), held across 3 regions of England. Telehealth was compared with usual-care, with general practice as the unit of randomization. Participant-reported outcome measures (Short-Form 12, EuroQual-5D, Diabetes Health Profile scales, Brief State-Trait Anxiety Inventory, and Centre for Epidemiological Studies Depression Scale) were collected at baseline, short-term (4 months) and long-term (12months) follow-ups. Intention-to-treat analyses testing treatment effectiveness, were conducted using multilevel models controlling for practice clustering and a range of covariates. Analyses assumed participants received their allocated treatment and were conducted for participants who completed the baseline plus at least one follow-up assessment (n=317).Results Primary analyses showed differences between telehealth and usual care were small and only reached significance for 1 scale (diabetes health profile-disinhibited eating, P=.006). The magnitude of differences between trial arms did not reach the trial-defined minimal clinically important difference of 0.3 standard deviations for most outcomes. Effect sizes (Hedge's g) ranged from 0.015 to 0.143 for Generic quality of life (QoL) measures and 0.018 to 0.394 for disease specific measures.ConclusionsSecond generation home-based telehealth as implemented in the WSD evaluation was not effective in the subsample of people with diabetes. Overall, telehealth did not improve or have a deleterious effect quality of life or psychological outcomes for patients with diabetes over a 12-month period.

Dataset Information

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

Methods/design

Discussion

Trial registration

Publications

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.

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