Background

Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer.

Methods

This multi-centre, pragmatic randomised controlled trial (RCT) will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks.

For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective.

Discussion

The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.

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

A report on the British Society for Plant Pathology, Presidential meeting 'Plant pathogen genomics - from, sequence to application', University of Nottingham, UK, 15-18 December 2003.

A report on the British Society for Plant Pathology Presidential meeting 'Plant pathogen genomics - from sequence to application', University of Nottingham, UK, 15-18 December 2003.

53BP1 is a human BRCT protein that was originally identified as a p53-interacting protein by the Saccharomyces cerevisiae two-hybrid screen. Although the carboxyl-terminal BRCT domain shows similarity to Crb2, a DNA damage checkpoint protein in fission yeast, there is no evidence so far that implicates 53BP1 in the checkpoint. We have identified a Xenopus homologue of 53BP1 (XL53BP1). XL53BP1 is associated with chromatin and, in some cells, localized to a few large foci under normal conditions. Gamma-ray irradiation induces increased numbers of the nuclear foci in a dose-dependent manner. The damage-induced 53BP1 foci appear rapidly (in 30 min) after irradiation, and de novo protein synthesis is not required for this response. In human cells, 53BP1 foci colocalize with Mrel1 foci at later stages of the postirradiation period. XL53BP1 is hyperphosphorylated after X-ray irradiation, and inhibitors of ATM-related kinases delay the relocalization and reduce the phosphorylation of XL53BP1 in response to X-irradiation. In AT cells, which lack ATM kinase, the irradiation-induced responses of 53BP1 are similarly affected. These results suggest a role for 53BP1 in the DNA damage response and/or checkpoint control which may involve signaling of damage to p53.

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.

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.