Dataset Information

Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish 'TeleCare North' cluster-randomised trial.

ABSTRACT:

Objective

To assess the effect of telehealthcare compared with usual practice in patients with chronic obstructive pulmonary disease (COPD).

Design

A cluster-randomised trial with 26 municipal districts that were randomly assigned either to an intervention group whose members received telehealthcare in addition to usual practice or to a control group whose members received usual practice only (13 districts in each arm).

Setting

Twenty-six municipal districts in the North Denmark Region of Denmark.

Participants

Patients who fulfilled the Global Initiative for COPD guidelines and one of the following criteria: COPD Assessment Test score ?10; or Medical Research Dyspnoea Council Scale ?3;?or Modified Medical Research Dyspnoea Council Scale ?2; or ?2 exacerbations during the past 12 months.

Main outcome measures

Health-related quality of life (HRQoL) assessed by the physical component summary (PCS) and mental component summary (MCS) scores of the Short Form 36-Item Health Survey, Version 2. Data were collected at baseline and at 12?month follow-up and analysed according to the intention-to-treat principle with complete cases, n=574 (258 interventions; 316 controls) and imputed data, n=1225 (578 interventions, 647 controls) using multilevel modelling.

Results

In the intention-to-treat analysis (n=1225), the raw mean difference in PCS from baseline to 12?month follow-up was -2.6 (SD 12.4) in the telehealthcare group and -2.8 (SD 11.9) in the usual practice group. The raw mean difference in MCS scores in the same period was -4.7 (SD 16.5) and -5.3 (SD 15.5) for telehealthcare and usual practice, respectively. The adjusted mean difference in PCS and MCS between groups at 12 months was 0.1 (95% CI -1.4 to 1.7) and 0.4 (95% CI -1.7 to 2.4), respectively.

Conclusions

The overall sample and all subgroups demonstrated no statistically significant differences in HRQoL between telehealthcare and usual practice.

Trial registration number

NCT01984840; Results.

SUBMITTER: Lilholt PH

PROVIDER: S-EPMC5623392 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Publications

Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish 'TeleCare North' cluster-randomised trial.

Lilholt Pernille Heyckendorff PH Witt Udsen Flemming F Ehlers Lars L Hejlesen Ole K OK

BMJ open 20170509 5

<h4>Objective</h4>To assess the effect of telehealthcare compared with usual practice in patients with chronic obstructive pulmonary disease (COPD).<h4>Design</h4>A cluster-randomised trial with 26 municipal districts that were randomly assigned either to an intervention group whose members received telehealthcare in addition to usual practice or to a control group whose members received usual practice only (13 districts in each arm).<h4>Setting</h4>Twenty-six municipal districts in the North De ...[more]

PMID: 28490555

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Project description:OBJECTIVES:To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. DESIGN:A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. SETTING:Community-based setting in the geographical area of North Denmark Region in Denmark. PARTICIPANTS:26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. INTERVENTIONS:In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. MAIN OUTCOME MEASURE:Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. RESULTS:From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI -754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI -0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). CONCLUSIONS:Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. TRIAL REGISTRATION:Clinicaltrials.gov, NCT01984840, 14 November 2013.

Project description:PurposeResults from the Danish cluster-randomized trial of telehealthcare to 1,225 patients with chronic obstructive pulmonary disease (COPD), the Danish Telecare North Trial, concluded that the telehealthcare solution was unlikely to be cost-effective, by applying international willingness-to-pay threshold values. The purpose of this article was to assess potential sources of variation across subgroups, which could explain overall cost-effectiveness results or be utilized in future economic studies in telehealthcare research.MethodsFirst, the cost-structures and cost-effectiveness across COPD severities were analyzed. Second, five additional subgroup analyses were conducted, focusing on differences in cost-effectiveness across a set of comorbidities, age-groups, genders, resource patterns (resource use in the social care sector prior to randomization), and delivery sites. All subgroups were investigated post hoc. In analyzing cost-effectiveness, two separate linear mixed-effects models with treatment-by-covariate interactions were applied: one for quality-adjusted life-year (QALY) gain and one for total healthcare and social sector costs. Probabilistic sensitivity analysis was used for each subgroup result in order to quantify the uncertainty around the cost-effectiveness results.ResultsThe study concludes that, across the COPD severities, patients with severe COPD (GOLD 3 classification) are likely to be the most cost-effective group. This is primarily due to lower hospital-admission and primary-care costs. Telehealthcare for patients younger than 60 years is also more likely to be cost-effective than for older COPD patients. Overall, results indicate that existing resource patterns of patients and variations in delivery-site practices might have a strong influence on cost-effectiveness, possibly stronger than the included health or sociodemographic sources of heterogeneity.ConclusionFuture research should focus more on sources of heterogeneity found in the implementation context and the way telehealthcare is adopted (eg, by integrating formative evaluation into cost-effectiveness analyses).Trial registrationClinicaltrials.gov, NCT01984840.

Project description:BackgroundSeveral feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone.Methods/designThe present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight).DiscussionThere has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial.Trial registrationClinicaltrials.gov, http://NCT01984840, November 14, 2013.

Project description:ObjectiveTo investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care.Design24 month, multicentre, pragmatic cluster randomised controlled trialSetting40 general practices in the western part of the NetherlandsParticipantsPatients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team.InterventionGeneral practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines).Main outcome measuresThe primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes.ResultsOf a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference -0.01, 95% confidence interval -0.10 to 0.08; P=0.8). After 12 months, no differences were seen in secondary outcomes between groups, except for the PACIC domain "follow-up/coordination" (indicating improved integration of care) and proportion of physically active patients. Exacerbation rates as well as number of days in hospital did not differ between groups. After 24 months, no differences were seen in outcomes, except for the PACIC follow-up/coordination domain.ConclusionIn this pragmatic study, an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care, except improved level of integrated care and a self reported higher degree of daily activities. The contradictory findings to earlier positive studies could be explained by differences between interventions (provider versus patient targeted), selective reporting of positive trials, or little room for improvement in the already well developed Dutch healthcare system.Trial registrationNetherlands Trial Register NTR2268.

Project description:ObjectiveTo assess the cost-effectiveness of a structured education pulmonary rehabilitation programme (SEPRP) for chronic obstructive pulmonary disease (COPD) relative to usual practice in primary care. The programme consisted of group-based sessions delivered jointly by practice nurses and physiotherapists over 8 weeks.DesignCost-effectiveness and cost-utility analysis alongside a cluster randomised controlled trial.Setting32 general practices in Ireland.Participants350 adults with COPD, 69% of whom were moderately affected.InterventionsIntervention arm (n=178) received a 2 h group-based SEPRP session per week over 8 weeks delivered jointly by a practice nurse and physiotherapist at the practice surgery or nearby venue. The control arm (n=172) received the usual practice in primary care.Main outcome measuresIncremental costs, Chronic Respiratory Questionnaire (CRQ) scores, quality-adjusted life years (QALYs) gained estimated using the generic EQ5D instrument, and expected cost-effectiveness at 22 weeks trial follow-up.ResultsThe intervention was associated with an increase of €944 (95% CIs 489 to 1400) in mean healthcare cost and €261 (95% CIs 226 to 296) in mean patient cost. The intervention was associated with a mean improvement of 1.11 (95% CIs 0.35 to 1.87) in CRQ Total score and 0.002 (95% CIs -0.006 to 0.011) in QALYs gained. These translated into incremental cost-effectiveness ratios of €850 per unit increase in CRQ Total score and €472 000 per additional QALY gained. The probability of the intervention being cost-effective at respective threshold values of €5000, €15 000, €25 000, €35 000 and €45 000 was 0.980, 0.992, 0.994, 0.994 and 0.994 in the CRQ Total score analysis compared to 0.000, 0.001, 0.001, 0.003 and 0.007 in the QALYs gained analysis.ConclusionsWhile analysis suggests that SEPRP was cost-effective if society is willing to pay at least €850 per one-point increase in disease-specific CRQ, no evidence exists when effectiveness was measured in QALYS gained.Trial registrationCurrent Controlled Trials ISRCTN52 403 063.

Project description:ObjectiveTo evaluate the effects of a community based integrated intervention for early prevention and management of chronic obstructive pulmonary disease (COPD) in China.DesignCluster randomised controlled trial.SettingEight healthcare units in two communities.ParticipantsOf 1062 people aged 40-89, 872 (101 with COPD and 771 without COPD) who fulfilled the inclusion and exclusion criteria were allocated to the intervention or the usual care programmes.InterventionParticipants randomly assigned to integrated intervention (systematic health education, intensive and individualised intervention, treatment, and rehabilitation) or usual care.Main outcome measuresAnnual rate of decline in forced expiratory rate in one second (FEV(1)) before use of bronchodilator.ResultsAnnual rate of decline in FEV(1) was significantly lower in the intervention community than the control community, with an adjusted difference of 19 ml/year (95% confidence interval 3 to 36) and 0.9% (0.1% to 1.8%) of predicted values (all P<0.05), as well as a lower annual rate of decline in FEV(1)/FVC (forced vital capacity) ratio (adjusted difference 0.6% (0.1% to 1.2%) P=0.029). There were also higher rates of smoking cessation (21% v 8%, P<0.004) and lower cumulative death rates from all causes (1% v 3%, P<0.009) in the intervention community than in the control community during the four year follow-up. Improvements in knowledge of COPD and smoking hazards, outdoor air quality, environmental tobacco smoke, and working conditions were also achieved (all P<0.05). The difference in cumulative incidence rate of COPD (both around 4%) and cumulative death rate from COPD (2% v 11%) did not reach significance between the two communities.ConclusionsA community based integrated intervention can have a significant impact on the prevention and management of COPD, mainly reflected in the annual rate of decline in FEV(1).Trial registrationChinese Clinical Trials Registration (ChiCTR-TRC-00000532).

Dataset Information

Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish 'TeleCare North' cluster-randomised trial.

Objective

Design

Setting

Participants

Main outcome measures

Results

Conclusions

Trial registration number

Publications

Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish 'TeleCare North' cluster-randomised trial.

Similar Datasets

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