Dataset Information

A Telemonitoring and Hybrid Virtual Coaching Solution "CAir" for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients' disabilities. Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention. OBJECTIVE:This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and to investigate its effects on the health-related quality of life of patients with COPD. METHODS:A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching. Participants randomized to the intervention group will receive a CAir Desk and a hybrid digital coaching intervention for 12 weeks. As a primary outcome, we will measure the delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire, from baseline to week 12 (the end of the intervention). RESULTS:The development of the CAir Desk and virtual coach has been completed. Recruitment to the trial started in September 2020. We expect to start data collection by December 2020 and expect it to last for approximately 18 months, as we follow a multiwave approach. We expect to complete data collection by mid-2022 and plan the dissemination of the results subsequently. CONCLUSIONS:To our knowledge, this is the first study investigating a combination of telemonitoring and hybrid virtual coaching in patients with COPD. We will investigate the effectiveness, efficacy, and usability of the proposed intervention and provide evidence to further develop app-based and chatbot-based disease monitoring and interventions in COPD. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT04373070; https://clinicaltrials.gov/ct2/show/NCT04373070. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/20412.

SUBMITTER: Gross C

PROVIDER: S-EPMC7644383 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Telemonitoring and Hybrid Virtual Coaching Solution "CAir" for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial.

Gross Christoph C Kohlbrenner Dario D Clarenbach Christian F CF Ivankay Adam A Brunschwiler Thomas T Nordmann Yves Y V Wangenheim Florian F

JMIR research protocols 20201022 10

<h4>Background</h4>Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients' disabilities. Technological progress a ...[more]

PMID: 33090112

Similar Datasets

Project description:RationaleHospital readmission for chronic obstructive pulmonary disease (COPD) has attracted attention owing to the burden to patients and the health care system. There is a knowledge gap on approaches to reducing COPD readmissions.ObjectivesTo determine the effect of comprehensive health coaching on the rate of COPD readmissions.MethodsA total of 215 patients hospitalized for a COPD exacerbation were randomized at hospital discharge to receive either (1) motivational interviewing-based health coaching plus a written action plan for exacerbations (the use of antibiotics and oral steroids) and brief exercise advice or (2) usual care.Measurements and main resultsWe evaluated the rate of COPD-related hospitalizations during 1 year of follow-up. The absolute risk reductions of COPD-related rehospitalization in the health coaching group were 7.5% (P = 0.01), 11.0% (P = 0.02), 11.6% (P = 0.03), 11.4% (P = 0.05), and 5.4% (P = 0.24) at 1, 3, 6, 9, and 12 months, respectively, compared with the control group. The odds ratios for COPD hospitalization in the intervention arm compared with the control arm were 0.09 (95% confidence interval [CI], 0.01-0.77) at 1 month postdischarge, 0.37 (95% CI, 0.15-0.91) at 3 months postdischarge, 0.43 (95% CI, 0.20-0.94) at 6 months postdischarge, and 0.60 (95% CI, 0.30-1.20) at 1 year postdischarge. The missing value rate for the primary outcome was 0.4% (one patient). Disease-specific quality of life improved significantly in the health coaching group compared with the control group at 6 and 12 months, based on the Chronic Respiratory Disease Questionnaire emotional score (emotion and mastery domains) and physical score (dyspnea and fatigue domains) (P < 0.05). There were no differences between groups in measured physical activity at any time point.ConclusionsHealth coaching may represent a feasible and possibly effective intervention designed to reduce COPD readmissions. Clinical trial registered with www.clinicaltrials.gov (NCT01058486).

Project description:RationaleSocioeconomically disadvantaged patients with chronic obstructive pulmonary disease (COPD) often face barriers to evidence-based care that are difficult to address in public care settings with limited resources.ObjectivesTo determine the benefit of health coaching for patients with moderate to severe COPD relative to usual care.MethodsWe conducted a randomized controlled trial of 9 months of health coaching versus usual care for English- or Spanish-speaking patients at least 40 years of age with moderate to severe COPD. Primary outcomes were COPD-related quality of life and the dyspnea subscale of the Chronic Respiratory Disease Questionnaire. Secondary outcomes were self-efficacy for managing COPD, exercise capacity (6-min walk test), and number of COPD exacerbations. Additional outcomes were COPD symptoms, lung function (forced expiratory volume in 1 s percent predicted), smoking status, bed days owing to COPD, quality of care (Patient Assessment of Chronic Illness Care), COPD knowledge, and symptoms of depression (Patient Health Questionnaire). Outpatient visits, emergency department visits, and hospitalizations were assessed by review of medical records. Generalized linear modeling was used to adjust for baseline values and account for clustering by clinic.ResultsOf 192 patients enrolled, 158 (82%) completed 9 months of follow-up. There were no significant differences between study arms for the primary or secondary outcomes. At 9 months, patients in the coached group reported better quality of care (mean Patient Assessment of Chronic Illness Care score, 3.30 vs. 3.18; adjusted P = 0.02) and were less likely to report symptoms of moderate to severe depression (Patient Health Questionnaire score, ≥15) than those in the usual care arm (6% vs. 20%; adjusted P = 0.01). During the study, patients in the coaching arm had 48% fewer hospitalizations related to COPD (0.27/patient/yr vs. 0.52/patient/yr), but this difference was not significant in the adjusted analysis.ConclusionsThese results help inform expectations regarding the limitations and benefits of health coaching for patients with COPD. They may be useful to health policy experts in assessing the potential value of reimbursement and incentives for health coaching-type activities for patients with chronic disease. Clinical trial registered with www.clinicaltrials.gov (NCT02234284).

Project description:BackgroundChronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) often coexist and are associated with a high morbidity and reduced quality of life (QoL). Although these diseases share similarities in symptoms and clinical course, and exacerbations of both diseases often overlap, care pathways for both conditions are usually not integrated. This results in frequent outpatient consultations and suboptimal treatment during exacerbations, leading to frequent hospital admissions. Therefore, we propose an integrated care pathway for both diseases, using telemonitoring to detect deterioration at an early stage and a single case manager for both diseases.ObjectiveThis study aims to investigate whether an integrated care pathway using telemonitoring in patients with combined CHF and COPD results in a higher general health-related QoL (HRQoL) as compared with the traditional care pathways. Secondary end points include disease-specific HRQoL, level of self-management, patient satisfaction, compliance to the program, and cost-effectiveness.MethodsThis is a monocenter, prospective study using a quasi-experimental interrupted time series design. Thirty patients with combined CHF and COPD are included. The study period of 2.5 years per patient is divided into a preintervention phase (6 months) and a postintervention phase (2 years) in which end points are assessed. The intervention consists of an on-demand treatment strategy based on monitoring symptoms related to CHF/COPD and vital parameters (weight, blood pressure, heart rate, oxygen saturation, temperature), which are uploaded on a digital platform. The monitoring frequency and the limit values of the measurements to detect abnormalities are determined individually. Monitoring is performed by a case manager, who has the opportunity for a daily multidisciplinary meeting with both the cardiologist and the pulmonologist. Routine appointments at the outpatient clinic are cancelled and replaced by telemonitoring-guided treatment.ResultsFollowing ethical approval of the study protocol, the first patient was included in May 2018. Inclusion is expected to be complete in May 2021.ConclusionsThis study is the first to evaluate the effects of a novel integrated care pathway using telemonitoring for patients with combined CHF and COPD. Unique to this study is the concept of remote on-demand disease management by a single case manager for both diseases, combined with multidisciplinary meetings. Moreover, modern telemonitoring technology is used instead of, rather than as an addition to, regular care.Trial registrationNetherlands Trial Register NL6741; https://www.trialregister.nl/trial/6741.International registered report identifier (irrid)DERR1-10.2196/20571.

Project description:BackgroundAlthough a number of studies have suggested that the use of Telemonitoring (TM) in patients with Chronic Obstructive Pulmonary Disease (COPD) can be useful and efficacious, its real utility in detecting Acute Exacerbation (AE) signaling the need for prompt treatment is not entirely clear. The current study aimed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life (HRQL) and to reduce utilization of healthcare services.MethodsA 12-month Randomised Controlled Trial (RCT) was conducted in the Veneto region (Italy). Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual's normal range. The study's primary endpoint was HRQL, measured by the Italian version of the two Short Form 36-item Health Survey (SF36v2). Its secondary endpoints were: scores on the Hospital Anxiety and Depression Scale (HADS); the number and duration of hospitalizations; the number of readmissions; the number of appointments with a pulmonary specialist; the number of visits to the emergency department; and the number of deaths.ResultsThree hundred thirty-four patients were enrolled and randomized into two groups for a 1 year period. At its conclusion, changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [(-2.07 (8.98) vs -1.91 (7.75); p = 0.889 and -1.08 (11.30) vs -1.92 (10.92); p = 0.5754, respectively]. Variations in HADS were not significantly different between the two groups [0.85 (3.68) vs 0.62 (3.6); p = 0.65 and 0.50 (4.3) vs 0.72 (4.5); p = 0.71]. The hospitalization rate for AECOPD and/or for any cause was not significantly different in the two groups [IRR = 0.89 (95% CI 0.79-1,04); p = 0.16 and IRR = 0.91 (95% CI 0,75 - 1.04); p = 0.16, respectively]. The readmission rate for AECOPD and/or any cause was, however, significantly lower in the TM group with respect to the control one [IRR = 0.43 (95% CI 0.19-0.98); p = 0.01 and 0.46 (95% CI 0.24-0.89); p = 0.01, respectively].ConclusionStudy results showed that in areas where medical services are well established, TM does not significantly improve HRQL in patients with COPD who develop AE. Although not effective in reducing hospitalizations, TM can nevertheless facilitate continuity of care during hospital-to-home transition by reducing the need for early readmission.Trial registrationRetrospectively registered on January 2012, ClinicalTrials.gov Identifier: NCT01513980 .

Project description:RationalePhysical inactivity among patients with chronic obstructive pulmonary disease is associated with exacerbations requiring high-cost health care utilization including urgent, emergent, and hospital care.ObjectivesTo examine the effectiveness of a behavioral lifestyle physical activity intervention combined with chronic obstructive pulmonary disease self-management education to prevent high-cost health care utilization.MethodsThis was an analysis of secondary outcomes of the Chronic Obstructive Pulmonary Disease Self-Management Activation Research Trial, a two-arm randomized trial of stable adult outpatients with chronic obstructive pulmonary disease recruited from primary care and pulmonary clinics. Following a 6-week self-management education run-in period, participants were randomized to usual care or to a telephone-delivered home-based health coaching intervention over 20 weeks. Secondary outcomes of physical activity and health care utilization were determined by self-report 6, 12, and 18 months after randomization. Associations between treatment allocation arm and these secondary outcomes were examined using log-binomial and Poisson regression models.ResultsA total of 325 outpatients with stable chronic obstructive pulmonary disease were enrolled in the trial. Their average age was 70.3 years (standard deviation, 9.5), and 50.5% were female; 156 were randomized to usual care and 149 to the intervention. A greater proportion of participants reported being persistently active over the 18-month follow-up period in the intervention group (73.6%) compared with the usual care group (57.8%) (mean difference, 15.8%; 95% confidence interval, 4.0-27.7%). This association varied by severity of forced expiratory volume in 1 second impairment (P for interaction = 0.09). Those in the intervention group with moderate impairment (forced expiratory volume in 1 second, 50-70% predicted), more frequently reported being persistently active compared with the usual care (86.0 vs. 65.1%; mean difference, 20.9%; 95% confidence interval, 5.7-36.1%). Patients with severe and very severe forced expiratory volume in 1 second impairment (forced expiratory volume in 1 second < 50% predicted) in the intervention group also reported being persistently active more frequently compared with usual care (63.3 vs. 50.8%; mean difference, 12.6%; 95% confidence interval, -4.7 to 29.8). The intervention was associated with a lower rate of lung-related utilization (adjusted rate ratio, 0.38; 95% confidence interval, 0.23-0.63) only among participants with severe spirometric impairment.ConclusionsOur results demonstrate that a feasible and generalizable home-based coaching intervention may decrease sedentary behavior and increase physical activity levels. In those with severe chronic obstructive pulmonary disease, this intervention may reduce lung disease-related health care utilization. Clinical trial registered with www.clinicaltrials.gov (NCT01108991).

Project description:IntroductionChronic obstructive pulmonary disease (COPD) is a prevalent chronic lung disease characterised by persistent and progressive airflow obstruction resulting from tracheal and/or alveolar lesions. Patients afflicted with COPD endure a poor quality of life primarily due to the symptoms of the disease. Pulmonary rehabilitation (PR) constitutes a core component of the comprehensive management of individuals dealing with COPD. Nevertheless, suboptimal adherence and completion rates are the chief impediments associated with PR. Virtual reality (VR) is emerging as a promising approach to support patients with COPD in their PR journey. Currently, no comprehensive systematic review has evaluated the impact of VR as a PR adjunct in patients with COPD. We aimed to investigate and summarise the evidence from recent studies related to the effect of VR as an adjunct to PR in COPD cases.Methods and analysisWe will conduct a comprehensive search of databases, including Web of Science, CINAHL, PubMed, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov, from their inception up to May 2023 to identify randomised controlled trials examining VR as an adjunct to PR in patients with COPD, with no restrictions on publication status or language. Our primary outcome measure will be the 6-min walk test. Two independent researchers will screen the literature for suitable articles for inclusion in this meta-analysis. Data collection and assessment of bias risk will be performed. This meta-analysis is intended to furnish data on each outcome as sufficient data become available. Heterogeneity will be assessed using the χ2 test and I2 statistics. The current review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Ethics and disseminationEthical approval is waived due to the retrospective nature of this study. Furthermore, the findings will be disseminated through peer-reviewed journals.Prospero registration numberCRD42022374736.

Dataset Information

A Telemonitoring and Hybrid Virtual Coaching Solution "CAir" for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial.

Publications

A Telemonitoring and Hybrid Virtual Coaching Solution "CAir" for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets