In idiopathic pulmonary fibrosis (IPF), home monitoring experiences are limited, not yet real-time available nor implemented in daily care. We evaluated feasibility and potential barriers of a new home monitoring program with real-time wireless home spirometry in IPF. Ten patients with IPF were asked to test this home monitoring program, including daily home spirometry, for four weeks. Measurements of home and hospital spirometry showed good agreement. All patients considered real-time wireless spirometry useful and highly feasible. Both patients and researchers suggested relatively easy solutions for the identified potential barriers regarding real-time home monitoring in IPF. Keywords: Idiopathic pulmonary fibrosis, eHealth, Home monitoring, Spirometry Introduction wireless home spirometry. Furthermore, we evaluated Idiopathic pulmonary fibrosis (IPF) is a progressive, dev- potential barriers and solutions for implementation of astating disease with a poor prognosis . Symptoms as wireless home spirometry in this mostly elderly patient increasing shortness of breath and immobility make population. regular hospital visits a challenge for many patients. New eHealth technologies hold great potential for re- Methods search and care by facilitating real-time, frequent data This was a prospective pilot study at the Erasmus collection at home. In IPF, home monitoring experiences Medical Center in 2017. Consecutive outpatients with are limited and not yet implemented in daily care. Few IPF were invited to participate. Approval of the Medical studies using daily handheld spirometry have been ethics committee was obtained, and participants provided performed in patients with IPF [2, 3]. These studies written informed consent. Patients were asked to test the showed that home spirometry in IPF is feasible, may home monitoring program “IPF-online” (http://www.ip- allow for better disease prediction and decrease sample fonline.nl) for four weeks on a tablet. IPF-online is a size for future trials [2, 3]. However, earlier studies using secured online personal platform, following European home spirometry in interstitial lung diseases used safety regulations. The program consists of daily home paper-based collection or central read-out of Forced spirometry, online patient-reported outcomes (PROs) at Vital Capacity (FVC) results [2–4]. This limits possibil- baseline and after four weeks, weekly reporting of ities to control quality of measurements, or respond side-effects and symptoms on visual analogue scales, an directly to FVC decline or non-adherence. information library, medication coach and eConsultations. We assessed feasibility of a pre-developed home moni- The bluetooth-enabled spirometer (MIR Spirobank Smart, toring program in IPF , integrated with real-time, Italy) transmits data real-time via a secure encrypted con- nection, enabling patients and healthcare providers to ac- * Correspondence: firstname.lastname@example.org cess data directly (Fig. 1). The system generates email Department of Respiratory Medicine, Erasmus University Medical Center, ‘s-Gravendijkwal 230, Rotterdam 3015, CE, The Netherlands alerts when patients report bothersome side-effects or © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Moor et al. Respiratory Research (2018) 19:105 Page 2 of 5 Fig. 1 a Daily FVC in % predicted of one patient during two weeks. A star on top of the bar corresponds with a forced expiration > 6 s, and is intended as extra motivation for patients. b Two examples of flow volume loops including daily remarks/advices FVC declines > 10% for three consecutive days. If patients Results fail to perform spirometry or record symptoms, they Of 12 patients invited to participate, 10 patients were receive a reminder. Incorporated PROMs are King’sBrief included (9 men), with a mean age of 71 years (5). All Interstitial Lung Disease health status questionnaire, patients were on disease-modifying medication (60% Hospital Anxiety and Depression Scale, Euroqol 5D-5 L nintedanib, 40% pirfenidone). The mean FVC was 3.28 L and an evaluation questionnaire [6–8]. At start, patients (1.04) or 79% of predicted (16). received standardized instructions about the correct useof home spirometryand the different components Reliability of home spirometry of the online tool. Patients were considered trained Measurements of home and hospital spirometry for FVC when they were able to perform three good, reprodu- (r = 0.94 (p < 0.001)) and FEV1 (r = 0.97 (p < 0.001)) were cible FVC measurements, with less than 150 ml dif- highly correlated, and a Bland-Altman plot showed good ference in the two highest FVCs. Before start of the agreement (Fig. 2). Median difference between hospital study, potential barriers of the system were identified and home spirometry was 0.22 L (0.01-0.69 L) with over- based on literature and own experiences. At baseline, all lower readings for home spirometry. To evaluate potential barriers were discussed with patients. After within-subject reproducibility, the median SD for 28 four weeks, their experiences and suggestions were measurements was calculated (0.13 L (0.05 -0.39 L)). evaluated. Furthermore, patients performed hospital The median coefficient of variation was 3.76% (3-12%). spirometry at baseline and after four weeks. Pearson correlation and Bland-Altman plots were used Feasibility and potential barriers of home spirometry in to compare home with hospital spirometry, Wilcoxon patients with IPF signed ranked test was used to compare baseline with The vast majority of patients considered daily spirometry follow-up scores. Data are presented as mean (SD) or easy (80%) and not burdensome at all (90%), the other median (range). patients were neutral. The mean adherence to home Moor et al. Respiratory Research (2018) 19:105 Page 3 of 5 Fig. 2 Bland-Altman plot comparing hospital and home spirometry. The value for hospital FVC is the mean of the hospital-based FVC at baseline and after four weeks. The value for home spirometry is the mean of 28 home FVC readings. The solid line represents the mean difference and the dashed lines 95% limits of agreement (− 0.61 to 0.90 L).* This patient did not use the mouthpiece correctly leading to more variable and higher readings compared to hospital spirometry spirometry was 98.8% (2.5). Most patients (80%) found it relative variability of home-based FVC is low, indicat- pleasant to see their FVC results, 20% was neutral. All ing that home spirometry is a reliable tool to monitor patients considered real-time spirometry useful and patients at a distance. In a patient population with would recommend it to others, 90% wished to continue progressive breathlessness and decreasing mobility home monitoring after the pilot: “It helps me feel more this enables close monitoring, while lowering the in control”, “I like to monitor my own disease and be burden of hospital visits, especially in countries with monitored” and “I hope this program can replace out- long distances to the hospital. Moreover, real-time patient clinic visits in the future”. Daily home monitor- uploading of results and automated email alerts not ing did not lead to higher anxiety levels (HADS anxiety only allow quality review of measurements, it also score at baseline 4.5, score after 4 weeks 4.3, p = 0.57), enables real-time detection of FVC decline. For ex- and quality of life remained stable (K-BILD total score at ample, we already observed a decrease in FVC two baseline 59.2, score after 4 weeks 60.3, p = 0.65). Table 1 days before a patient reported symptoms of a respira- provides a comprehensive overview of potential barriers, tory tract infection. Early detection may potentially experiences and solutions for use of the home monitor- improve efficiency and quality of care for patients. ing system. Besides spirometry, patients also recorded symptoms and validated questionnaires online, which could be Discussion important additional features for future studies. This pilot study shows that a home monitoring program All patients in our study supported the usefulness integrated with real-time wireless home spirometry is of home monitoring, and appreciated being actively feasible in patients with IPF. In line with other involved in monitoring their disease. One patient studies, home-based measurements were slightly lower experienced technical problems with spirometry, than hospital-based FVC, which may partly be highlighting the importance of good instruction. No equipment-related, but also effort-related [2, 4]. We effects on anxiety or quality of life were observed, tried to minimize the risk for ‘underperforming’ at however, we believe that the duration of the study is home by motivating patients through graphically too short to draw definite conclusions on this. We displaying their personal target value and prior found no major barriers regarding use of real-time results, a six seconds countdown and advices to tech- wireless home spirometry; relatively easy solutions nically improve the measurements. However, home were suggested by patients and investigators for po- and hospital readings are highly correlated and the tential issues. Moor et al. Respiratory Research (2018) 19:105 Page 4 of 5 Table 1 A comprehensive overview of the identified potential barriers for use of the home monitoring system (wireless and real-time), experiences from the pilot study, and possible solutions as suggested by patients and staff Potential barriers for the use of real-time Findings in our pilot experiment Possible solutions home spirometry No internet access Patient who never used internet before had - Provide patients with a smartphone or tablet with no problems using the tablet and perform 4G SIM card during study to guarantee internet access spirometry because of the simple design. - Use a simple application without too much information Quality of measurements is difficult All patients performed mostly good quality - New wireless spirometers have automated quality control to control flow volume loops, which could be checked and provide advice to patients real-time. - Use a device that shows a flow volume loop accessible to patient and researchers to review quality A handheld spirometer may be difficult A few patients had to get used to handheld - Provide a clear instruction manual and good training at to use spirometry the first days. start of the study. Patients should be able to perform Only one patient had variable results, due to 3 good quality measurements with ≤150 ml difference in technical difficulties with the standard the 2 highest FVC’s. mouthpiece. After providing an additional - Assess individual patients’ needs mouthpiece the readings were comparable - Consider using an extra/other mouthpiece to hospital readings. - Use a video consultation or clinic visit for refreshment training Motivation A 6 s countdown and FVC target value is - Do not use an FVC of 100% predicted as target value as always shown during a forced expiration. this might demotivate patients This motivated patients to blow as good - Provide an individual target value for each patient and and long as possible. adjust target value during study if necessary Home spirometry might induce coughing Some patients mentioned more urge to - Advise patients to perform spirometry after a period cough compared to hospital spirometry, but of rest one measurement a day was not a problem - Advise patients to try again later that day when a at all. measurement failed because of coughing Patients might get worried seeing their Anxiety and depression scores were not - Incorporate automated email alerts to the researchers own results higher after this short pilot. Almost all and explain to patients that they will be contacted if FVC patients considered it pleasant to see their declines significantly daily results. - Provide an extra option that blinds patients from their results Daily home spirometry can be None of the patients in the pilot considered - Advise patients to perform spirometry at almost the bothersome to patients once daily spirometry bothersome, because same time every day to create a routine it was not time consuming and became part - Explain that the whole process takes less than two of their routine. minutes Compliance Patients got motivated by keeping track of - Send patients email reminders when they do not their own results and almost all patients perform spirometry or report their symptoms continued home spirometry after the pilot. A limitation of this study is that it is a single center Conclusion study, with 10 out of 12 consecutive patients willing A home monitoring program including wireless home to participate. In the Netherlands, use of internet spirometry, is highly feasible and appreciated by patients amongst elderly people is rather high, however, also with IPF, and enables real-time detection of change in in other countries internet use among people over the FVC and PROs facilitating personalized care. age of 65 is steadily growing . With worldwide in- creasing internet use and technological advances, we Abbreviations envision that relatively simple and low-cost systems FVC: Forced Vital Capacity; IPF: Idiopathic Pulmonary Fibrosis; PROs: Patient Reported Outcomes like this, will facilitate access to care and research for a wider group of patients, also in remote areas and lower socio-economic settings. Further limitations of Acknowledgements The authors thank the patients who collaborated with us in this study for their this pilot are the small sample size and short dur- valuable input and suggestions to enhance the home monitoring program. ation. Although this was sufficient to evaluate reliabil- ity and potential barriers of a home monitoring program with real-time wireless home spirometry, lar- Funding This study was supported by a grant from the Erasmus MC Thorax ger studies are required to assess whether it improves Foundation. Hoffman la Roche and Boehringer Ingelheim provided an care, allows for earlier detection of exacerbations, and unrestricted grant for software development. None of them had any enhances data collection in clinical trials. influence on the design, content and conduct of the study. Moor et al. Respiratory Research (2018) 19:105 Page 5 of 5 Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Authors’ contributions All authors were involved in the design of the study and data collection. CM and MSW analysed and the data and drafted the manuscript, MW, JM, JG and PP revised it critically for important intellectual content. All authors read and approved the final manuscript. Ethics approval and consent to participate Approval of the Medical ethics committee of the Erasmus Medical Center in Rotterdam was obtained (MEC-2017-388), and all participants provided written informed consent. Competing interests CM, MW, JM, JG and PC declare no conflicts of interest. MSW reports grants from Erasmus MC Thorax Foundation, Hoffman- la Roche, and Boehringer – Ingelheim related to the submitted work, and other from Galapagos, outside the submitted work. Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Received: 30 March 2018 Accepted: 10 May 2018 References 1. Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, et al. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011;183:788–824. 2. Russell AM, Adamali H, Molyneaux PL, Lukey PT, Marshall RP, Renzoni EA, Wells AU, Maher TM. Daily home spirometry: an effective tool for detecting progression in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2016;194:989–97. 3. Johannson KA, Vittinghoff E, Morisset J, Lee JS, Balmes JR, Collard HR. Home monitoring improves endpoint efficiency in idiopathic pulmonary fibrosis. Eur Respir J. 2017;50(1). https://doi.org/10.1183/13993003.02406-2016. 4. Broos CE, Wapenaar M, Looman CWN, In 't Veen J, van den Toorn LM, Overbeek MJ, Grootenboers M, Heller R, Mostard RL, Poell LHC, et al: Daily home spirometry to detect early steroid treatment effects in newly treated pulmonary sarcoidosis. Eur Respir J. 2018;51(1). https://doi.org/10.1183/ 13993003.02089-2017. 5. Moor CC, van Manen MJG, Tak NC, van Noort E, Wijsenbeek MS. Development and feasibility of an eHealth-tool for Idiopathic Pulmonary Fibrosis. Eur Respir J. 2018;51(3). https://doi.org/10.1183/13993003.02508-2017. 6. Patel AS, Siegert RJ, Brignall K, Gordon P, Steer S, Desai SR, Maher TM, Renzoni EA, Wells AU, Higginson IJ, Birring SS. The development and validation of the King's brief interstitial lung disease (K-BILD) health status questionnaire. Thorax. 2012;67:804–10. 7. Brooks R. EuroQol: the current state of play. Health Policy. 1996;37:53–72. 8. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70. 9. Eurostat Internet access and use statistics - households and individuals. http://ec.europa.eu/eurostat/statistics-explained/index.php/Internet_access_ and_use_statistics_-_households_and_individuals. Accessed 21 May 2018.
Respiratory Research – Springer Journals
Published: May 29, 2018
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