Abstract
Continuous positive airway pressure (CPAP) is an effective treatment for obstructive sleep apnoea (OSA), but treatment compliance is often unsatisfactory. This study investigated the efficacy and cost-effectiveness of telemonitoring for improving CPAP compliance.
100 newly diagnosed OSA patients requiring CPAP (apnoea–hypopnoea index >15 events·h−1) were randomised to standard management or a telemonitoring programme that collected daily information about compliance, air leaks and residual respiratory events, and initiated patient contact to resolve issues. Clinical/anthropometric variables, daytime sleepiness and quality of life were recorded at baseline and after 3 months. Patient satisfaction, additional visits/calls, side-effects and total costs were assessed.
There were no significant differences between the standard and telemedicine groups in terms of CPAP compliance (4.9±2.2 versus 5.1±2.1 h·night−1), symptoms, clinical variables, quality of life and unwanted effects. Telemedicine was less expensive than standard management (EUR123.65 versus EUR170.97; p=0.022) and was cost-effective (incremental cost-effectiveness ratio EUR17 358.65 per quality-adjusted life-year gained). Overall patient satisfaction was high, but significantly more patients rated satisfaction as high/very high in the standard management versus telemedicine group (96% versus 74%; p=0.034).
Telemonitoring did not improve CPAP treatment compliance and was associated with lower patient satisfaction. However, it was more cost-effective than traditional follow-up.
Abstract
Telemonitoring did not improve CPAP compliance, showed lower patient satisfaction, but proved to be cost-effective http://ow.ly/UvHX306AC0V
Introduction
Obstructive sleep apnoea (OSA) is a highly prevalent disorder, affecting 10% of adult men and 4% of adult women in Western countries [1]. It is characterised by recurrent collapse of the upper airway during sleep, leading to nocturnal hypoxaemia, sleep fragmentation and daytime hypersomnolence. Untreated OSA is associated with a higher risk of developing arterial hypertension, cardiovascular and cerebrovascular diseases, as well as a worse quality of life (QoL) [2–5]. Moreover, OSA is a risk factor for traffic accidents and has an important socioeconomic impact [6, 7].
First-line therapy for moderate to severe OSA is the application of continuous positive airway pressure (CPAP), which provides a pneumatic splint and prevents upper airway collapse during sleep [8]. Good CPAP adherence (use of the device for at least 4 h·night–1) [9], may improve QoL and daytime sleepiness, decrease the risk of new-onset hypertension and cardiovascular events, and reduce blood pressure in patients with resistant hypertension [10–13]. Adherence is therefore essential for the efficacy of CPAP treatment, and the optimisation of adherence and compliance is an important aspect of patient management.
Although published evidence shows that CPAP is a highly effective therapy, a significant proportion of patients (up to 36%) underuse or even discontinue CPAP [14–16], mostly because of treatment-related side-effects (e.g. pressure intolerance, claustrophobia, mask displacement and machine noise) [17] and lack of improvement in symptoms. Many of these problems could be solved by a closer follow-up, allowing patients to continue effective therapy, but this would increase the workload for sleep units that are already operating at full capacity and increase the cost of managing OSA. Therefore, new methods of facilitating and improving CPAP compliance are needed, particularly during the first months of treatment when long-term CPAP compliance is established [18].
Recent technologies have already enabled CPAP devices to monitor applied pressures, air leaks, the apnoea–hypopnoea index (AHI) and objective adherence, and to send this information to a patient's healthcare provider on a daily basis. These systems could allow early detection of problems and facilitate appropriate interventions, thereby improving early experience with CPAP and potentially improving long-term adherence [19].
This pilot study compared the effectiveness of a telemonitoring-based strategy versus standard follow-up on compliance with CPAP treatment in OSA patients.
Methods
Study design and patients
This prospective randomised controlled study was conducted at the sleep unit of St Maria Hospital (Lleida, Spain) between January and July 2015, and included adult patients (>18 years) with newly diagnosed OSA requiring treatment with CPAP (AHI >15 events·h−1). Assuming an α risk of 0.05 and a β risk of 0.2 in a two-sided test, a sample size of 49 subjects in each group was needed to detect differences ≥1 h in CPAP treatment compliance. A common standard deviation of 1.75 was assumed. Given the high motivation of both professionals and patients to be involved, no dropouts were anticipated and thus a total of 100 patients were planned to be recruited.
Patients were randomised to have CPAP therapy managed using standard care or a telemonitoring-based strategy and followed up over 3 months. Patients with impaired lung function (overlap syndrome, obesity hypoventilation and restrictive disorders), severe heart failure, psychiatric disorders, periodic leg movements, pregnancy, other dysomnias or parasomnias, and/or a history of previous CPAP treatment were excluded. The study was approved by the hospital's ethics committee and registered at ClinicalTrials.gov (trial number NCT02517346). All recruited patients signed an informed consent form.
Interventions
Patients randomised to standard care were fitted with a mask and given a CPAP device (AirSense 10; ResMed, Martinsried, Germany) and a leaflet explaining how to use it. A short instruction session on how to use a CPAP device was also given to patients and partners in the sleep unit by a trained nurse with experience in the follow-up of CPAP-treated patients. This included a practical demonstration of how to put on the mask, and the correct management and cleaning of the tubes, masks and humidifier. Information on how to turn the CPAP device on and off was provided by the homecare provider at the time of machine delivery. All patients were visited after 1 month of treatment by the specialist nurse at the sleep unit. Information about CPAP pressure, compliance and adherence (use of CPAP for ≥4 h·day−1), residual respiratory events and leaks were downloaded from the device. CPAP-related side-effects, CPAP machine care and maintenance (changes of mask, tubes and humidifier), and the number of additional visits and calls were recorded by the nurse.
In the telemonitoring group, patients were also fitted with a mask and given a CPAP device (AirSense 10) and a leaflet explaining how to use it, and received the same training sessions from the same personnel as in the standard care arm. Each CPAP device given to patients in this group was equipped with mobile 2G (GSM/GPRS) technology capable of sending daily information on CPAP adherence, CPAP pressures, mask leak and residual respiratory events to the MyOSA–Oxigen Salud web database (www.oxigensalud.com) Automatic alarms for the provider were generated in case of mask leak >30 L·min−1 for >30% of the night or usage of <4 h·night−1 on two consecutive nights. In case of alarm, the pulmonary specialist medical officer of the CPAP provider contacted the patient, providing case-by-case problem solving. This included suggestions about how to minimise symptoms (dry mouth, mask issues, discomfort with the device), specific interventions to improve compliance (mask changing, chin strap, pressure or humidifier settings, saline nasal sprays) and support for the patient in the use of CPAP.
Assessments
Clinical variables and anthropometric parameters (age, sex, blood pressure, body weight, height, body mass index (BMI), neck, waist and hip circumference), daytime sleepiness (based on Epworth Sleepiness Scale score) and QoL (assessed using the EuroQol EQ-5D health questionnaire; www.euroqol.org) were recorded by a sleep unit physician during clinic visits at baseline and at 3 months. At the 3-month evaluation, patients were asked to rate their satisfaction with therapy using a questionnaire, and information about CPAP pressures, compliance and adherence (CPAP utilisation ≥4 h·day−1), residual respiratory events, and leaks was downloaded from all CPAP devices by the physician. In addition, the physician recorded CPAP-related side-effects, CPAP machine care and maintenance (changes of mask, tubes and humidifier), and the number of additional visits and calls.
Costs
Total direct and indirect costs of each intervention were assessed to perform cost and cost-effective analyses. The costs of hospital visits and telephone consultations with sleep unit physicians were assessed using prices provided by the Catalan Institute of Health [20]. No OSA-related hospital admissions were recorded during the follow-up and thus no additional costs due to hospitalisations had to be added. Costs for telephone consultations with the CPAP provider, visits from the CPAP provider, changes in materials related to the CPAP device, and additional costs for 2G (GSM/GPRS) daily data transfer and patients' activation and maintenance of daily data monitoring by the CPAP provider in the telemonitoring group were assessed using prices provided by the CPAP provider. All costs related to the CPAP provider were paid by the Catalan Institute of Health and thus all direct costs were assessed from a healthcare system perspective. Patients' costs related to travel to the sleep unit or CPAP provider offices were calculated and included as indirect costs, and thus these indirect costs were assessed from a patient perspective. A full list of costs recorded is provided in online supplementary table S1. The cost-effectiveness of both strategies for managing OSA patients undergoing CPAP treatment was evaluated by calculating the incremental cost-effectiveness ratio (ICER) [21]. The ICER is based on total costs incurred and quality-adjusted life-years (QALYs) gained, and calculates the ratio between the differences in the cost (EUR) and effectiveness (QALYs) of both strategies.
Statistical analysis
Continuous variables were expressed as mean±standard deviation, while categorical variables were reported as absolute numbers and percentages. Differences between study groups were assessed using the Chi-squared or Fisher's exact test to compare dichotomous variables, and the t-test for continuous variables. Linear or logistic regression analyses were used, as appropriate, to compare differences between study groups. Age, sex, AHI and variables that differed at baseline (p<0.100) were included as covariates. Cost differences between study groups were assessed using the Mann–Whitney two-sample statistic. Sensitivity analyses were performed for 25% and 50% increases in CPAP provider costs.
All tests were two-sided and p-values <0.05 were considered statistically significant. All analyses were performed on both an intention-to-treat and a per-protocol basis. Statistical analyses were performed using Stata version 12.1 (StataCorp, College Station, TX, USA).
Results
A total of 100 subjects were randomised: 48 to standard care and 52 to telemedicine. Baseline patient demographic and clinical characteristics in the two intervention groups are shown in table 1. Overall, patients had a mean age of 55 years, 23% were women, were mostly obese (mean BMI 35 kg·m−2) and had a high AHI (mean 52 events·h−1). The only significant differences between the standard and telemedicine groups at baseline were a lower waist/hip ratio and a higher incidence of dyslipidaemia in the telemedicine versus standard care group (table 1). All results presented are for the intention-to-treat analysis; similar results were obtained in the per-protocol analysis.
Baseline patient demographic and clinical characteristics in 100 study patients
There were no significant differences between the standard care and telemedicine groups with regard to compliance with CPAP, improvement in symptoms and QoL, changes in clinical variables, and treatment-related side-effects after 3 months of follow-up (table 2).
Continuous positive airway pressure treatment compliance, symptoms, clinical variables, quality of life and treatment-related side-effects at 3 months of follow-up
Overall patient satisfaction at 3 months was good (table 3). Patients managed using telemedicine reported significantly lower overall satisfaction than those receiving standard care and tended to be less satisfied about appropriate contact with the hospital (table 3). Overall, patients managed using telemedicine placed a positive value on all aspects of the telemonitoring programme, with the exception of privacy aspects (table 3).
Patient satisfaction after 3 months of follow-up
Values for direct and indirect costs assessed during the study are summarised in table 4. The total average cost per randomised patient was 28% lower in the telemonitoring group than in the standard care group. This was primarily a result of lower costs for planned follow-up visits to the sleep unit, which are not required when telemonitoring is used. The number of QALYs gained was similar in each treatment group (0.060 for standard care and 0.057 for telemonitoring). The ICER for the telemonitoring strategy compared with standard care was EUR17 358.65 per QALY gained. Sensitivity analyses showed that increasing CPAP provider costs by 25% was associated with savings of EUR39.88 for telemonitoring versus standard care (p=0.048 for between-group comparison) and with savings of EUR32.43 when CPAP provider costs were increased by 50% (p=0.116) (online supplementary table S2).
Within-trial treatment and follow-up costs (average cost per randomised patient)
Discussion
This study is the second randomised controlled clinical trial to assess the effectiveness of telemonitoring for improving CPAP compliance, the largest to date in terms of the number of enrolled patients, and the first to include cost and cost-effectiveness analyses. Although there were no significant overall differences in CPAP treatment compliance between OSA patients managed using telemonitoring compared with standard care, use of the telemonitoring strategy reduced overall costs and was cost-effective. However, patient satisfaction was higher in the standard care group.
Contrary to expectations, telemonitoring did not improve CPAP compliance after 3 months of follow-up in our study. This is in contrast to the results of a Canadian randomised controlled trial enrolling 75 patients that showed a better compliance with auto-titrating positive airway pressure after 3 months of management using telemonitoring compared with standard care (191±147 versus 105±118 min·day−1; p=0.006) [19]. These contrasting results could be explained by differences between the studies in terms of compliance in control patients. In the present study, patients managed using standard care had a mean CPAP usage of 4.9 h·night−1 compared with 1.75 h·night−1 in the Canadian study [19]. This suggests that the comparative effectiveness of telemonitoring for improving CPAP compliance is dependent on the baseline compliance of patients in whom telemonitoring is utilised.
Other trials have explored different telemedicine approaches to improve CPAP compliance, including teleconsultation with a physician [22], periodic automated calls retrieving patient's self-reported information [23], daily internet-based informational support and feedback [24], and telehealth sessions with a nurse [25]. However, the results of these trials were inconsistent, thus reinforcing the idea of the additional efficacy of telemonitoring strategies being highly dependent on the baseline characteristics and compliance of the target population, as well as the proposed telemedicine intervention.
A key aspect of any new treatment strategy, including telemedicine, is the cost of the intervention and its cost-effectiveness. In the current study, both direct and indirect costs were included in a cost-effectiveness analysis, which showed that the telemonitoring strategy used was less expensive and more cost-effective than standard management. Although other telemedicine interventions to improve CPAP compliance have been shown to be less costly than standard care [22], this is the first CPAP compliance telemonitoring trial to specifically report cost-effectiveness. The main source of savings in the telemedicine arm was the reduction in planned monitoring visits, which were partially replaced by a remote intervention. The combination of lower management costs and similar compliance compared with standard care meant that the intervention was cost-effective.
We expected that a reduction in the number of clinic/hospital visits combined with easy monitoring would be appreciated by patients. However, although patient satisfaction was high in both groups, it was significantly higher in the standard management group. Several factors may have contributed to this finding. First, patients willing to participate in a clinical trial are usually highly motivated and thus may be less concerned about avoiding hospital visits than an average patient. Second, contact with the CPAP provider rather than with a hospital physician could be seen to be less satisfactory by some patients. Finally, as reported in the specific telemonitoring questionnaire, some patients reported concerns about their privacy, either because they were contacted due to low compliance or because their compliance data were held by non-hospital-based medical personnel. However, most patients placed a positive value on the usefulness of online information and telemonitoring. Therefore, there is obviously room for improvement regarding patient satisfaction with the telemedicine strategy used in this study. We hypothesise that there may be an initial barrier preventing patients from fully embracing and feeling comfortable with telemonitoring. It would therefore appear that better ways of educating patients about telemonitoring are required to ensure that they have an adequate understanding of both the suitability of the telemonitoring approach for the management of CPAP compliance and the protection of privacy, especially for patients who might be more attached to their hospital physician or more concerned about privacy issues. This could improve patient satisfaction with telemonitoring strategies.
Savings generated by use of the telemedicine approach, via avoidance of planned visits to the sleep unit, were significant and had an important impact in terms of cost-effectiveness. Moreover, telemonitoring could facilitate a reduction of the care burden at sleep units that are already operating at, or close to, maximum capacity.
The current study has several strengths, including the novelty of the 2G (GSM/GPRS) telemonitoring strategy, utilisation of the same CPAP devices in both study arms, inclusion of a broad range of effect measures (i.e. compliance, changes in symptoms and changes in QoL), evaluation of patient satisfaction, and the inclusion of cost and cost-effectiveness analyses. However, there are also some limitations that need to be taken into account. First, the assessment of patient satisfaction was performed using a nonvalidated questionnaire. The high level of compliance in the standard management group could have masked any potential benefits of telemonitoring. The exclusion of patients with other associated sleep disorders (periodic limb movements or other parasomnias), severe comorbidities (e.g. respiratory or cardiovascular diseases) and central sleep apnoea limits the generalisability of the current results to patients with pure OSA. Such patients are likely to be the ideal population for telemonitoring programmes. However, patients with more complex presentations are likely to benefit the most from standard management including close follow-up in sleep units. All cost analyses are highly dependent on the characteristics of the healthcare setting in which they are conducted. Therefore, extrapolation of the results to different settings should be done cautiously. Moreover, the possibility of unrealistic pricing of the supplied telemonitoring services cannot be completely ruled out, although sensitivity analyses increasing such costs by 25% and 50% were performed. Finally, the short follow-up period of this study (3 months) does not allow the extrapolation of the results to the long term.
Conclusions
In this study telemonitoring was not able to improve CPAP treatment compliance. Moreover, telemonitoring was associated with lower patient satisfaction compared with standard care. However, for the first time, telemonitoring was shown to be more cost-effective than standard care for the management of OSA, reducing the number of scheduled visits to the sleep unit. An extended follow-up period is needed to evaluate the long-term reproducibility of these results.
Supplementary material
Supplementary Material
Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.
Supplementary tables S1 and S2 ERJ-01128-2016_Supplement
Disclosures
Supplementary Material
F. Barbé ERJ-01128-2016_Barbe
A. Mayoral ERJ-01128-2016_Mayoral
H. Woehrle ERJ-01128-2016_Woehrle
Acknowledgements
The authors would like to thank all the patients involved in the study, as well as the kind support from Maricel Arbonés, Olga Mínguez and Lídia Pascual (Group of Translational Research in Respiratory Medicine, IRBLleida, Lleida, Spain).
Author contributions: C. Turino and J. de Batlle had full access to all of the data in the study and take responsibility for the content of the manuscript, including the integrity of the data. M. Sánchez-de-la-Torre and F. Barbé conceived and designed the study. C. Turino, A. Mayoral, A.L. Castro-Grattoni, S. Gómez and M. Dalmases were involved in the data acquisition. J. de Batlle analysed the data. C. Turino and J. de Batlle wrote the first draft of the manuscript. C. Turino, J. de Batlle, H. Woehrle, M. Sánchez-de-la-Torre and F. Barbé contributed to the interpretation of the data and clinical inputs. All authors were involved in the revision of the manuscript for important intellectual content and approved the final version to be published.
Footnotes
This article has supplementary material available from erj.ersjournals.com
Received: June 07 2016 | Accepted after revision: Nov 20 2016
This study is registered at www.clinicaltrials.gov with identifier number NCT02517346.
Support statement: This study was partially funded by ResMed Spain (Spain) and ALLER (Spain). Funding information for this article has been deposited with the Open Funder Registry.
Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com
- Copyright ©ERS 2017
References
