Implementation of a coagulation component into a phosphate kinetics model in haemodialysis therapy: A tool for detection of clotting problems?

A coagulation component should be considered in phosphate kinetics modelling because intradialytic coagulation of the extracorporeal circuit and dialyser might reduce phosphate removal in haemodialysis. Thus, the objective of this study was to add and evaluate coagulation as an individual linear clearance reduction component to a promising three-compartment model assuming progressive intradialytic clotting. The model was modified and validated on intradialytic plasma and dialysate phosphate samples from 12 haemodialysis patients collected during two treatments (HD1 and HD2) at a Danish hospital ward. The most suitable clearance reduction in each treatment was identified by minimizing the root mean square error (RMSE). The model simulations with and without clearance reduction were compared based on RMSE and coefficient of determination (R2 ) values. Improvements were found for 17 of the 24 model simulations when clearance reduction was added to the model. The slopes of the clearance reduction were in the range of 0.011-0.632/h. Three improvements were found to be statistically significant (|observed z value| > 1.96). A very significant correlation (R2  = 0.708) between the slopes for HD1 and HD2 was found. Adding the clearance reduction component to the model seems promising in phosphate kinetics modelling and might be explained, at least in part, by intradialytic coagulation. In future studies, the model might be developed further to serve as a potentially useful tool for the quantitative detection of clotting problems in haemodialysis. NEW FINDINGS: What is the central question of this study? The aim was to add an intradialytic coagulation component to a modified version of a promising three-compartment phosphate kinetics model. The hypothesis was that circuit and dialyser clotting can be modelled by an individual linear phosphate clearance reduction component during haemodialysis treatment. What is the main finding and its importance? Improvements were found for 17 of 24 model simulations when clearance reduction was added to the model. Thus, the kinetics model seems promising and could be a useful tool for the quantitative detection of clotting problems in haemodialysis patients.

Patient-Reported Outcomes for Function and Pain in Total Knee Arthroplasty Patients.

BACKGROUND: Some patients undergoing total knee arthroplasty successfully manage their condition postoperatively, whereas others encounter challenges in regaining function and controlling pain during recovery at home. OBJECTIVE: The aim of this study was to use traditional statistics and machine learning to develop prediction models that identify patients likely to have increased care needs related to managing function and pain following total knee arthroplasty. METHODS: This study included 201 patients. Outcomes were changes between baseline and follow-up in the functional and pain subcomponents of the Oxford Knee Score. Both classification and regression modeling were applied. Twenty-one predictors were included. Tenfold cross-validation was used, and the regression models were evaluated based on root-mean-square error, mean absolute error, and coefficient of determination. Classification models were evaluated based on the area under the receiver operating curve, sensitivity, and specificity. RESULTS: In classification modeling, random forest and stochastic gradient boosting provided the best overall metrics for model performance. A support vector machine and a stochastic gradient boosting machine in regression modeling provided the best predictive performance. The models performed better in predicting challenges related to function compared to challenges related to pain. DISCUSSION: There is valuable predictive information in the data routinely collected for patients undergoing total knee arthroplasty. The developed models may predict patients who are likely to have enhanced care needs regarding function and pain management. Improvements are needed before the models can be implemented in routine clinical practice.

Phosphate Kinetic Models in Hemodialysis: A Systematic Review.

BACKGROUND: Understanding phosphate kinetics in dialysis patients is important for the prevention of hyperphosphatemia and related complications. One approach to gain new insights into phosphate behavior is physiologic modeling. Various models that describe and quantify intra- and/or interdialytic phosphate kinetics have been proposed, but there is a dearth of comprehensive comparisons of the available models. The objective of this analysis was to provide a systematic review of existing published models of phosphate metabolism in the setting of maintenance hemodialysis therapy. STUDY DESIGN: Systematic review. SETTING & POPULATION: Hemodialysis patients. SELECTION CRITERIA FOR STUDIES: Studies published in peer-reviewed journals in English about phosphate kinetic modeling in the setting of hemodialysis therapy. PREDICTOR: Modeling equations from specific reviewed studies. OUTCOMES: Changes in plasma phosphate or serum phosphate concentrations. RESULTS: Of 1,964 nonduplicate studies evaluated, 11 were included, comprising 9 different phosphate models with 1-, 2-, 3-, or 4-compartment assumptions. Between 2 and 11 model parameters were included in the models studied. Quality scores of the studies using the Newcastle-Ottawa Scale ranged from 2 to 11 (scale, 0-14). 2 studies were considered low quality, 6 were considered medium quality, and 3 were considered high quality. LIMITATIONS: Only English-language studies were included. CONCLUSIONS: Many parameters known to influence phosphate balance are not included in existing phosphate models that do not fully reflect the physiology of phosphate metabolism in the setting of hemodialysis. Moreover, models have not been sufficiently validated for their use as a tool to simulate phosphate kinetics in hemodialysis therapy.

Interaction between functional health literacy and telehomecare: Short-term effects from a randomized trial.

This study was conducted as part of a randomized, controlled trial, and explored whether the introduction of a Danish telehomecare intervention, referred to as 'the Telekit', and its associated educational components affect functional health literacy. The study sample consisted of 60 chronic obstructive pulmonary disease patients in the intervention group who received the Telekit, and 56 in the control group; all participants were collected from the large-scale, randomized TeleCare North trial by consecutive sampling. To avoid recall bias, the design did not include a baseline measurement, comparing instead the post-intervention measurements between the intervention and control groups. First, the comparability of the two groups was determined, and statistically significant differences in their functional health literacy scores were examined using an independent t-test. Furthermore, the associations between functional health literacy and both groups were tested using multiple regression analysis. No statistically significant difference was observed between the intervention and control groups, suggesting that the introduction of the Telekit and its associated educational components has no effect on functional health literacy. However, further research should be conducted using a larger sample.

Validation of the Test of Functional Health Literacy in Adults in a Danish population.

OBJECTIVE: To describe how the original American full-length version of the Test of Functional Health Literacy in Adults (TOFHLA) was translated and adapted for use in the Danish setting and culture. A reliable Danish version of the TOFHLA was created and pretested using patients diagnosed with chronic obstructive pulmonary disease (COPD) as case group. METHODS: Forty-two patients with COPD completed the Danish TOFHLA and participated in a face-to-face interview concerning their basic demographics. Statistical analyses were conducted to explore the demographic data provided by the participants and to determine the internal consistency and reliability of the Danish TOFHLA. RESULTS: The mean age of sample was 68.7 years (range 34-86). The face validity, internal consistency and item to scale correlations of the Danish TOFHLA were determined and found to fulfil well-established criteria; on this basis, we found the reliability and consistency of the Danish TOFHLA to be satisfying. CONCLUSION: The Danish TOFHLA is now ready for application in future research projects, which test levels of functional health literacy in an elderly Danish population at risk of chronic diseases. The evolvement in the measurement of health literacy is still ongoing, as there is a need to refine existing methods. Until recently, there has been a total lack of instruments for assessing health literacy in Scandinavia; it is hoped that this development of the Danish TOFHLA will promote further research within the field of health literacy in Scandinavia and other European countries.

A telemonitoring intervention design for patients with poorly controlled type 2 diabetes: protocol for a feasibility study.

BACKGROUND: Maintaining optimal glycemic control in type 2 diabetes (T2D) is difficult. Telemedicine has the potential to support people with poorly regulated T2D in the achievement of glycemic control, especially if the telemedicine solution includes a telemonitoring component. However, the ideal telemonitoring design for people with T2D remains unclear. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring designs for people with non-insulin-dependent T2D with a goal of identifying the optimal telemonitoring intervention for a planned future large-scale randomized controlled trial. METHOD: This 3-month randomized feasibility study will be conducted in four municipalities in North Denmark starting in January 2024. There will be 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) combined with sleep and mental health monitoring. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, sources of differences in direct intervention costs between the two alternative interventions will be investigated. DISCUSSION: Telemonitoring has the potential to support people with diabetes in achieving glycemic control, but the existing evidence is inconsistent, and thus, the optimal design of interventions remains unclear. The results of this feasibility study are expected to produce relevant information about telemonitoring designs for people with T2D and help guide the design of future studies. A well-tested telemonitoring design is essential to ensure the quality of telemedicine initiatives, with goals of user acceptance and improved patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT06134934 . Registered November 1, 2023. The feasibility trial has been approved (N-20230026) by the North Denmark Region Committee on Health Research Ethics (June 5, 2023).

Effectiveness of Telemedicine in Managing Diabetes in Pregnancy: A Systematic Review and Meta-Analysis.

BACKGROUND: Strict monitoring of blood glucose during pregnancy is essential for ensuring optimal maternal and neonatal outcomes. Telemedicine could be a promising solution for supporting diabetes management; however, an updated meta-analysis is warranted. This study assesses the effects of telemedicine solutions for managing gestational and pregestational diabetes. METHODS: PubMed, EMBASE, Cochrane Library Central Register of Controlled Trials, and CINAHL were searched up to October 14, 2020. All randomized trials assessing the effects of telemedicine in managing diabetes in pregnancy relative to any comparator without the use of telemedicine were included. The primary outcome was infant birth weight. A meta-analysis comparing the mean difference (MD) in birth weight across studies was applied, and subgroup and sensitivity analyses were performed. The revised Cochrane tool was applied to assess the risk of bias, and the certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. RESULTS: From a total of 18 studies, ten (totaling 899 participants) were used to calculate the effect on infant birth weight. The results nonsignificantly favored the control (MD of 19.34 g; [95% confidence interval, CI -47.8; 86.47]), with moderate effect certainty. Heterogeneity was moderate (I2 = 37.39%). Statistically significant secondary outcomes included differences in two-hour glucose tolerance postpartum (gestational diabetes; two studies: standardized mean difference 9.62 mg/dL [95% CI: 1.95; 17.28]) that favored the control (GRADE level, very low) and risk of shoulder dystocia (four studies: log odds -1.34 [95% CI: -2.61; -0.08]) that favored telemedicine (GRADE, low). CONCLUSIONS: No evidence was found to support telemedicine as an alternative to usual care when considering maternal and fetal outcomes. However, further research is needed, including economic evaluations.

Patient support ICT tool for hypertension monitoring.

Detection of hypertension is traditionally a matter for the general practitioner, but an alternative detection scheme is home blood pressure measurement by patients, on patients' or doctors' decision. We designed and implemented a prototype software tool to provide information about hypertension, video instructions on correct home blood pressure measurement technique and a measurements diary. The system was developed using standard, software development methods and techniques. The program was developed for Danish-speaking patients. Usability (navigability, level and outcome of instructions, logical arrangement, level and focus of information, and program accessibility) was evaluated in a think-aloud test with test users performing specific, realistic tasks. The prototype provides written information about hypertension, written and video instructions on correct blood pressure measurement technique, and measurements diary functionality. All test users performed all tasks and rated navigability, level and outcome of instructions, logical arrangement, level and focus of information, and program accessibility high, and had positive attitudes towards the system. The components in the patient support tool can be used separately or in combination. The effects of video for home blood pressure measurement technique instruction remain unexplored.

The potential of dividing the oxford knee score into subscales for predicting clinically meaningful improvements in pain and function of patients undergoing total knee arthroplasty.

BACKGROUND: Subdividing the Oxford Knee Score (OKS) into a pain component scale (OKS-PCS) and a function component scale (OKS-FCS) for predicting clinically meaningful improvements may provide a basis for identifying patients in need of enhanced support from health care professionals to manage pain and functional challenges following total knee arthroplasty. AIM: To assess the potential of dividing the OKS into subscales for predicting clinically meaningful improvements in pre- and postoperative pain and function by comparing two different versions of extracting pain and function derived from the OKS. METHODS: This retrospective observational cohort study included 201 patients undergoing total knee arthroplasty. Multiple logistic regression analysis was applied for binary classification of whether patients achieved clinically meaningful improvements in pain and function. RESULTS: The best overall version for predicting clinically meaningful improvements had an area under the receiver operating characteristic curve of 0.79 for both pain and function, whereas Nagelkerke's R2 was 0.322 and 0.334, respectively. CONCLUSION: The findings indicate that it is reasonable to subdivide the OKS into subscales for predicting clinically meaningful improvements in pain and function. However, more studies are needed to compare various types of classification algorithms in larger patient populations.

A pilot assessment of why patients choose not to participate in self-monitoring oral anticoagulant therapy.

Patients suffering from heart diseases often face lifelong oral anticoagulant therapy. Traditionally, the patient's general practitioner takes care of the treatment. An alternative management scheme is a self-monitoring setup where the patient monitors and manages the oral treatment himself. Despite international evidence of reduced thrombosis risk and death rate among patients enrolled in self-monitoring, a majority of eligible patients deselect this opportunity. Little is about the causes if this. This study is a pilot assessment of why patients, located in the North Denmark Region, choose not to participate. The study is based on qualitative interviews with two nurses working in a medical practice and two patients participating in conventional anticoagulant therapy. The results of this study seem to suggest that at least some patients feel a lack of information to base their decision regarding self-monitoring or conventional management on and that the knowledge among the health personnel at the medical clinics should be increased.

Data mining to assess variations in oral anticoagulant treatment.

Variations in International Normalized Ratio's (INR) are closely related to bleeding and thrombosis incidents in patients on oral anticoagulation treatment. This study investigates predictive factors that affect INR values. Data sampled with relatively high frequency allows for detection of local INR variations, and hence also allows detection and evaluation of predictive factors where time is taken into consideration. Univariate linear regression was applied and different models were reduced into a final predictive model. F-tests were utilized to test whether or not a model reduction would benefit INR predictions, in terms of decreasing observed variance. In addition to an INR submodel, the final model includes individual interaction from the last three days change in mean warfarin intake and three days change in mean vitamin K intake. Prediction residual error was mainly reduced by the INR submodel, while the warfarin model and the vitamin K submodel did not benefit predictions to same extend compared to the INR submodel. However, more studies on the temporal aspects of the effect of warfarin seem to be relevant.

Clinical implications of a quality assessment of transcutaneous CO2 monitoring in preterm infants in neonatal intensive care.

More than 1% of infants are born premature. Many of these children require special treatment because of immature organs and body functions. CO2 is an important parameter to monitor in order to avoid serious brain damage. Blood sampling of CO2 has several shortcomings and non-invasive transcutaneous CO2 is being investigated in order to assess its potential to contribute with the same type of information as blood CO2 measurements. The present study assesses the quality of transcutaneous CO2 data by comparing it to the "golden standard" blood CO2 data, in order to provide clinicians with a better understanding of the usefulness and limitations of transcutaneous CO2 data in neonatal care. The study shows that for low transcutaneous CO2 the error is relatively high and in most cases the true CO2, represented by the blood CO2, which can be regarded as the "gold standard", is higher than the measured transcutaneous CO2. The opposite is the case for high transcutaneous CO2. It is discussed how this is not due to any systematic error in the equipment, but due to the natural behaviour of noisy data.

Assessing importance of dietary data in anticoagulation treatment.

This paper describes the outcome of including information on dietary intake in the attempt to predict International Normalized Ratio (INR) values. An already published model has been extended and is now tested with the additional dietary data and without it. When predicting INR values seven days into the future, the new proposed model outperforms the existing one. It is concluded that adding information on dietary intake improves the accuracy of INR predictions.

Characteristics of Subjects With Undiagnosed COPD Based on Post-Bronchodilator Spirometry Data.

BACKGROUND: COPD is largely underdiagnosed. Patients with undiagnosed COPD need to be diagnosed to ensure early treatment institution. It is therefore relevant to obtain a more profound understanding of the characteristics of patients with undiagnosed COPD to improve COPD case finding. This study aimed to explore the characteristics of subjects with undiagnosed COPD from the United States National Health and Nutrition Examination Survey (NHANES) dataset (2007-2012) based on post-bronchodilator spirometry. METHODS: A multitude of statistical tests were performed to explore the potential characteristics of subjects with undiagnosed COPD. A total of 1,098 subjects with a post-bronchodilator FEV1/FVC < 0.7 or lower limit of normal (LLN) were included in the final sample. RESULTS: Undiagnosed subjects experienced less phlegm (P < .001), wheezing (P < .001), and chest pain (P < .001) than subjects diagnosed with COPD. They were characterized by less shortness of breath (P < .001), fewer work/school days lost to wheezing (P < .001), less sleep disturbance (P < .001), and less difficulty socializing (P < .001). The undiagnosed subjects felt less depressed (P < .001). Additionally, they were less likely to have asthma (P < .001). The annual household income was higher among the undiagnosed subjects (P < .001), and they were also characterized by higher FEV1 (P < .001), and FVC (P < .001). CONCLUSIONS: Subjects with undiagnosed COPD were characterized by fewer symptoms and had better lung function than their diagnosed counterparts.

A Decision Support Tool for Healthcare Professionals in the Management of Hyperphosphatemia in Hemodialysis.

Hyperphosphatemia is known as one of the more challenging conditions in end-stage renal disease patients. This study set out to present and evaluate a healthcare-oriented decision support tool in the management of hyperphosphatemia within hemodialysis therapy. A prototype module was designed to fit into the interface of a modern dialysis machine (Fresenius 5008). The prototype included three main functions: 1) immediate bedside blood sample access, 2) a model based prognosis tool with estimates of P-phosphate and 3) an overview of the user's phosphate related activities during dialysis treatments. The prototype was evaluated by a) heuristic evaluation with five human computer interaction experts and b) user testing with think-aloud by three users as (clinical) domain experts. The two evaluation procedures identified a total of 103 usability problems and led to some specific amendments to improve its practical potential. The overall results will guide further development of the decision support tool to ensure that the functions will support the user's needs. In conclusion, the prototype was evaluated to be relevant and potentially beneficial in the management of hyperphosphatemia in hemodialysis patients. Furthermore, it was found that some of the functions could be used for educational purposes or as decision support for some patient groups, e.g. for patient doing home-dialysis.

The impact of non-model-related variability on blood glucose prediction.

BACKGROUND: Physiological models are frequently used to predict blood glucose values from insulin and meal data of people with diabetes. Obviously, errors in the input data used result in prediction errors. A more complex problem is that no model may include all factors influencing the blood glucose level in any given situation. We have analyzed the influence of five parameters on prediction accuracy with respect to the time horizon. METHODS: A physiological model, consisting of an insulin model, a meal model, and a glucose metabolism model in combination with a Monte Carlo simulation, was used for this investigation. It was used to examine the change in blood glucose following the intake of carbohydrate and insulin. The intra-individual variability, which was studied, included pharmacokinetic variability of insulin aspart and estimation error of carbohydrate intake, as well as the accuracy of blood glucose meters and insulin pens. RESULTS: Simulations showed how the coefficient of variance for the different model compartments changes over time. For average people with diabetes the inaccuracies of blood glucose meters and carbohydrate estimates contribute to more than half of the variance. CONCLUSION: We showed how blood glucose prediction is severely affected by the inaccuracy in the input variables. Metabolic fluctuations, causing variability in insulin dynamics, also display important effects, but these are difficult to change. The inaccuracy of carbohydrate counting and the use of blood glucose meters appear to be the two main sources of error, which can be reduced through better patient education.

Modeling the effect of blood glucose and physical exercise on plasma adrenaline in people with type 1 diabetes.

BACKGROUND: Adrenaline is often studied in people with type 1 diabetes during hypoglycemic episodes. Adrenaline is difficult and costly to measure, and therefore a pharmacokinetic model of adrenaline can be a supportive tool that adds information and saves measurements resources. METHODS: We have developed a compartment model of adrenaline secretion and elimination. It is based on input on physical exercise, blood glucose level, and optional infused adrenaline. The model parameters are identified using least square regression on published data of adrenaline kinetics measured in a number of different clinical studies. RESULTS: Simulation of published adrenaline measurements shows agreement with data of adrenaline infusion (R(2) = 0.9), exercise (R(2) = 0.97), and hypoglycemic episodes (R(2) = 0.93-0.97). The identified function describing adrenaline secretion during hypoglycemia shows an exponential increase for a blood glucose decreasing below 3.5 mmol/L and an approaching maximum around 1 mmol/L. Exercise intensity increasing above 50% of maximal oxygen uptake maximum causes approximately exponential increase in adrenaline secretion. CONCLUSION: The model is a simple tool that can be used to simulate and predict adrenaline concentrations in situations of hypoglycemia, physical exercise, and adrenaline infusion. In conclusion, the developed model, although simple, seems to be useful for simulating adrenaline dynamics in situations with hypoglycemic episodes, physical exercise, or infusion.

Causes of misdiagnosis of chronic obstructive pulmonary disease: A systematic scoping review.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) has serious implications at both the individual and the societal level. It is crucial that COPD is diagnosed correctly to ensure provision of the right treatment. However, the current diagnostic procedures may lead to misdiagnosis. AIM: The aim of this scoping review was to disseminate knowledge about potential causes of misdiagnosis of COPD. METHODS: A systematic, comprehensive search was performed in PubMed, Embase and Cinahl. RESULTS: A thorough review produced a sample of 73 articles. The synthesis revealed five potential causes of misdiagnosis of COPD, including: the threshold for defining COPD (n = 36), errors made in primary care (n = 15), errors linked to the spirometry test (n = 13), differential diagnoses (n = 10), and patient-related factors (n = 8). CONCLUSIONS: The causes of misdiagnosis of COPD are attributable mainly to spirometry and to the healthcare professional performing the diagnostic assessment. With a view to limiting misdiagnosis of COPD, future research should help clarify strategies for alternative objective tests for determining if a patient has COPD and explore how to better support primary care in the diagnosing of COPD.

Subgroup analysis of telehealthcare for patients with chronic obstructive pulmonary disease: the cluster-randomized Danish Telecare North Trial.

PURPOSE: Results 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. METHODS: First, 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. RESULTS: The 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. CONCLUSION: Future 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 REGISTRATION: Clinicaltrials.gov, NCT01984840.

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: 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.