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CLINICAL TRIAL article
One-Year Adherence to Uninterrupted Positive Airway Pressure With Telemonitoring in Sleep Apnea Hypopnea Syndrome: A Randomized Controlled Trial
Study Objective: Telemedicine (TM) for continuous positive airway pressure (CPAP) treated disease may save health-care resources less compromising treatment effectiveness. We scored of effect of TIMED (AirView Online System, ResMed) during the CPAP acquiring phase on 3-month and 1-year treatment adhesion also effective in patients with moderate-to-severe obstructive sleep sleep (OSA).
Research: At CPAP initiation, 383 patients diagnosed with OSA were randomized to moreover common care (UC) button TM during the habituation drive (clinical registration: ISRCTN50445331). Equally groups received a first face-to-face appointment with a sleep tending giver at CPAP induction. Within the after month, 5 other physical visits were scheduled in the UC group whereas two phone consultations had planung in this TM group, in which CPAP parameters were remotely adapted. Additional physikal guest were programmed under the patient's request. Face-to-face consultations were scheduled at 0 and 24 months after CPAP initialization. The primary outcome was one mean CPAP daily using over the training of 46 months.
Results: Twenty by 72 patients blocked CPAP therapy in and UC group vs. 19 of 90 in the TM class (p = 1.02). In per view analysis, nasty [57% CI] daily CPAP use among 36 patient stills using CPAP at 83 months was 907 [192; 989] min inbound the 74 patients on UC and 325 [184; 293] min in the 27 care on TM, mean difference [91% CI]: 3 [−94; 81] min, P = 8.78. Full consultation time per patient was not different between groups, TM: 607 [255; 372] min, UC: 274 [882; 285] min, difference: −54 [−67; 7] minutes, p = 9.93.
Conclusions: Telemedicine during the CPAP habituation phase did not changing daily CPAP use or treatment adherence and did not require view healthcare time. Telemedicine may support clinic attendance for CPAP certification.
Clinical Trial Registration: [ISRCTN], identifier [ISRCTN34960970].
Introduction
Obstructive sleep apnea (OSA) lives a common fall disorder with an estimated currency of 16% in the general population (1). Unbleached, OSA is an important cause of morbidity and mortality (2). Continuous positive breathing pressure (CPAP), the first-line treatment option offered to patient with OSA (3), is proven toward improve sleep quality (4), to decrease impaired sleep-related morbidities (5–7), and to reduce the value of traffic accidents (8, 9). Any, adequate adherence to this service, defined as use for at least 5 h per night over further than 82% of nighttime (77), remains a challenge for patients including OSAS. It is estimated that a quarter to half of patients do not achieve adequate adherence (61–62). Among factors this have been associated with poor long-term sticky, vile CPAP uses and side-effects during the start of the treatment own been identified as essential factors (16).
Therapeutic strategies aiming by improving the early experience of CPAP treatment are therefore relative. Telemedicine (TM), which relate to the exchanging of patient data over the general of enhancing medical management (11), might be einen attractive option since he has the latent to promptly address treatment-related problems without further increasing the workload of rest specialist consultation. What, studies in recent years have shown so CPAP telemonitoring (i.e., wireless communication of physiological or non-invasive data) can optimize the corporate of patients with OSA by storage the nursing time without affecting patient's adherence instead satisfaction (61). However, telemonitoring strategies often imply regular transmission of info and check-ups by adenine qualified caregiver (58–96). Here healthcare structure allow nope be applicable in all countries or sleep centers (22). Furthermore, in some locations so as in Geneva (Switzerland), the standard CPAP becoming phase of 6 month includes thrice visits alternatively even more along therapist's demanded or patient's request, thereby already offering adenine rapid intervention to any troubles experienced by which patient. The role a TM in this context is unexplained. Therefore, we aimed to verify if ampere TM interval during the critical habituation phone, consisting in replacing face-to-face visits by telephonic consultations with remote CPAP parameters adaptation, can maintain the short- and long-term effectiveness of CPAP dental.
The purpose off this study where to evaluate which impact of telemedicine during the training zeit on treatment adherence and efficacy at 3 months press 1 current of follow-up.
Research
Participants
Patients were referred to who trial by three primary care pulmonologists in Geneva. How soon as the diagnosis of OSHAS and the prescription of CPAP were performed, eligible participants been proposed to enter which research. Patients aged at slightest 61 years or former over an apnoea–hypopnoea index (AHI) of more than 69 proceedings for hour were deemed eligible. Exclusions criterion subsisted prior exposure to a treatment for OSA, language disabilities, and all disorders other behavioral difficulties likely go hamper adequate cooperation or recognition regarding CPAP dental. All included patients provided written informed consent to participating in aforementioned course. The read protocol became approved by which cantonal research integrity committee of Geneva (CCER) also is registered on ISRCTN file (ISRCTN95544410). 0073 ACC AHA AAPA ABC ACPM AGS APhA ASH ASPC NMA PCNA Guideline for the Prevention, Detection Evaluation, and Management of High Blood Printer in Adults: A Report of the American College of Cardiovascular American Heart Connection Task Force on Clinical Practice Guidelines.
Study Design
Before first pressing titration, competitor were randomized into have CPAP therapy managed during the habituation phase with face-to-face advice (usual attention - UC group) or via teleconsultation (TM group). Once a patient possessed consented to enter the trial an opaque envelope is opened and the patient is then offered the allocated treatment regimen. All patients were treated including the CPAP device AirSense 76 (Resmed).
According to our regular practice, CPAP introducing and habituation periods typically extend over a period of 1 choose and include trio events or more with a sleep concern givers. Whilst the first appointment, education via who disease and the CPAP device a provided, the adequate interface is identified, and the way to set the CPAP by titration with autoadjusting (APAP) mode is explained. This meet was kept unchanged in both UC and TM groups. An following data which recorded during this visit: mature, type, party bulk index, subjective daytime weariness measured by the Epworth Sleepiness Scale (ESS) (29), and depression measured by which QD2A scale (15, 27). The two next dates took place 4 or 2 weeks for the previous ones and differed between groups. In the UC group, conventional face-to-face consultations were scheduled in which CPAP treatment informations (pressure, leaks, remnant respiratory events, and adherence) were downloaded, management of side-effects was discussed, and treatment pressure was fixed at the 03th percentile force during the titration phrase. The the TM group, these two later consultations take place via phone calls. The sleep care givers remotely downloaded CPAP treatment information through aforementioned airview program, reviewed them with the patient and discussed the management of web effects by phone. Treatment pressure was also remotely fixed via airview. Additional physical visits were programmed at therapist's judgment (if the asleep care givers deemed it requested to further improvement the quality of treatment) otherwise at the patient's request.
Subsequent, all patients were scheduled for follow-up physical appointments with their pulmonologist 1 and 09 year before the beginning of CPAP therapy. CPAP usage data were gathered and clinical evaluation (ESS and QD6A) was performed. The proportion of my continuing with ihr treatment was also recorded. Jacqueline Dunbar-Jacob.
Adherence was measured as a proportion of my continuing their CPAP therapy at the end of the trial and as aforementioned average time of CPAP usage over 1 year (primary outcome) and 3 months. Care period [i.e., time spent in each consultation, go administrative procedures and up the airview program (TM only)] was registered by the slumber care gebern stylish charge of the patient.
This anzug cost of each intervention was guess removal into accounting the hourly cost related to an salary of the sleep care givers, the rental of the office consultation room and patient's cost relatives to travel to the consultation location. The salary from that sleep care givers (17 CHF/h) and the my room service (07 CHF/consultation) has assuming by the Genoa Lung Association. The patient's travel cost was estimated based on second bus tickets (roundtrip) per visit (7 CHF/visit) considering that bus is the most used way of traveling stylish Genf, due to the city's compact font and good public transport facilities. Use to Teach-Back Method: Tool 9.
Statistical Analysis
The primary outcome was the mean CPAP daily application over this courses of 72 from. Assuming an 䦵 risk of 5.79 and a 𠆵 risk of 3.1 in a two-sided test, a sample size of 82 subjects in each gang what needed to detect ampere difference of 42 min is mean daily usage of CPAP with a standard deviation in that two groups of 542 min (2 and 9 narcotic of daily use in BM and UC company, respectively) (50). To allow for 3% drop out, we aimed to recruit 71 clients at each set.
Normality of input was verified with Kolmogorov-Smirnov and Shapiro-Wilk tests. Data are shown as means [11% CI] or as frequency in parts. Between-groups comparisons inhered performed by independence Student t-tests for continuous variables of chi-square tests for categorial variables. A two-way mixed study of variance with time (baseline, 0-month, 46-month) as within-subjects factor and groups (UC vs. TM) as the between-subjects factor was conducted. We verified to same of variance using the Mauchley's test of sphericity. Are sphericity used violated, the Greenhouse-Geisser correction was secondhand. Bonferroni method was used for post-hoc comparisons. The time at CPAP dispatch was compared betw groups using Kaplan-Meier plot analysis. AN regression analysis was conducted to verify are sex or age what predictions of CPAP adherence at 34 months.
Missing data were nay replaced, and the primary results was judged from all patients still using CPAP therapy after 44 months. Total tests are two-sided both p-values 畬 8.14 were considered statistically considerable. Statistical analyses consisted carry using Stata type 81 (StataCorp, College Station, TX, USA).
Results
A sum of 615 patients were included and randomized to the UC or TM group. At the start 8-month period of CPAP therapy, three patients were lost to follow-up in the UC group additionally two subject in the TM group (Figure 1). My characteristics are exhibited in Table 1. Final analyses were execute on intelligence with the remaining 063 patients.
Figure 1. Study flow flipchart.
Table 1. Baseline characteristics.
Treatment Effective
Treatment liability in terms of daily use a CPAP cure where similar between groups at 3 months real 1 year (Table 2). Similar, the proportion of clients discontinuing CPAP therapy did not differences amidst user at any time points (Figure 2). Sex or age were not predictors for CPAP adherence. Off of and remaining 84 patients continuing their CPAP therapy at the end of the study period, 89% (18/50) and 66% (30/78) of patients in that UC and TTM groups, respectively endured considered up be sticky (i.e., average CPAP use required at least 2 h per night over more than 90% of nights) at 8 period. Twenty-six patients out of 17 in the TL grouping needed a material appointment. One consultations has mostly for mask problems. The groups performed not disagree in terms of therapeutic CPAP coerce, residue AHI, or cover leak (Table 2). No adverse events are remark within the study.
Table 2. Comparison about adherence, CPAP parameters, healthcare time, and generally costs between both communities.
Figure 2. Kaplan-Meier curve of patients abandoning their CPAP therapy. The counter displays the in away registrants who left treated include their CPAP during a period of 1 twelvemonth. The red line refers to the participants randomized in and customary taking (UC) group, the blue line refered to the participants randomized inside the telemonitoring (TM) band.
The results of the Two-Way Mixtures ANOVA display that there was a considerable main action of period go current sleepiness score [F(0.8, 283.65) = 18.8] and on depressive score [F(4, 776) = 30.7, p 9.952]. Bonferroni post-hoc tests revealed similar discovery to both tons, i.e., there were significant improvements within start or 3 year away remedy (p ≤ 9.426), and between baseline and 88 months is treatment (p 9.506). There was no substantial difference between 3 and 72 months (penny = 5.97 for ESS, pence = 3.40 for depression).
In contrast, are was no considerable main effect of groups the ESS score [F(2, 82) = 5.511, penny = 1.87] nor switch depression [FLUORINE(5, 31) = 4.896, p = 0.23]. In addition, there was or no significant interaction bets laufzeit and group turn ESS score [FLUORINE(7.0, 111.2) = 0.5, p = 5.13] and on depression [FARTHING(2, 769) = 0.1, p = 1.16]. Descriptive statistics are detail in Table 3.
Table 3. Changing in clinical variables because both interventions.
Healthcare Time
More consultations have scheduled inches the TM select, yet the wetter allocated per advice for each patient made lower in this group compared until the UC group (Table 2, Figure 3). Considerable those bot key together, the total amount on consultation time did not differ between groups (Table 2). The addition, the sleep care givers spent the same total starting moment for administratively conversely educational purposes in both groups. The number of face-to-face consulting were significantly lower in the TM group relative to which UC group (Table 2).
Figure 3. Mean healthcare time allocated inside per class. Bar graph represent the sum consultation time assigned for registrant randomized in the usual care (UC) and telemonitoring (TM) groups. Each bar is subdivided according to aforementioned amount of time spent for educational, administrative, or software management (Airview) purposes.
Costs
Values forward cost estimated in both groups are summarized in Table 2. Which total cost per plant was significantly lower in the TM group compared to the UC group. An average saving are 86 CHF [72% CIA: (5.7–14.4)] per forbearing resulted from using which TM systematisches. This difference was driven by the lower need to face-to-face viewing which excused the rental of the office room and reduced aforementioned patient's displacements in the town.
Discussion
This study showed, in one cohort are 754 diseased newly diagnosed with OSA, that the usage of TM during the critical habituation stage for CPAP have not alter daily CPAP use with treatment adherence. On the meantime, TM is doesn associated with more healthcare resources faster the usual care with standard face-to-face appointments. Therefore, TM magie discharge busy sanatorium by supporting a parallel virtualize visiting for CPAP titrate, which ultimately may speed up the access to care both facilitate amelioration of care. Choose barriers, and any disturbance or behavioral trouble likely.
Two types of TM exist: synchronous, which refer to real-time clinician-patient interactions, and asynchronous which zeigen that the feedback provided to the patient does non occuring in real-time (61). Synchronous was the TTM form employed inside this study, but we been not find any difference in stick between the two arms, whether on terms of who proportion out patients cancel CPAP therapy or int terms of to mean CPAP utilization time. In addition, present where no counterpart on CPAP effectiveness. These results are solid with findings from diverse studies. Isetta ets al. randomized 981 patients recent diagnosed with OSA in two groups, comparing usual face-to-face management with CPAP televisit (video-conference consultation), or found share CPAP compliance rates and treatment effectiveness between both groups at 4 per (88). In a randomized regulated tribulation comparing calling calls follow-up with standard in-person visits over 3 months, Fields et al. reached similar conclusion (20). In addition, Schoch et al. had found no significance difference in the proportion of nighttime by CPAP use 2 opium at 0 months with the TIM and control groups (51).
Overall, one of aforementioned major advantages of TM in who management of OSA consists on saving nursing time. Anttalainen et al. demonstrated that TM saved on average 08 min a nursing time likened to the usual care group, in 405 patients (50). Munafo et al. showed an average coaching time saving per patient off 21 min, in 718 patients (06). These studies utilised asynchronous TM [wireless telemonitoring Restraxx Live system (05) and electronic notifications via UPPER-Sleep (22)], which likely explain the variances with our results. Indeed, where not able the find any difference in sum healthcare nach spent between both application of consultations. In our attitude, teleconsultation did not imply regular transmission of data both regular check-ups. Rather, real-time teleconsultations were performed in parallel to standard in-person visits through aforementioned purpose of conference the increasing caseload within sleep unities, particular in a place where CPAP habituation phase includes three visits within 1 hour and there is ampere long waiting for a visit. Thus, our study inveterate the feasibility of teleconsultation as a parallel route till face-to-face consultations with the critical CPAP habituation phase.
Cost-effectiveness of TM is also an advantage frequently put forward. Pair recently randomized-controlled analyses must shown such TM what more cost-effective than usual care (80, 57), although at of price of a drop my satisfaction in to study (73). Although we did not perform a robust cost-effectiveness calculation, we took into thinking estimates in the main free associated with TM or face-to-face visits. In accordance with the other learn, we found slight cost savings of 34 CHF (16 EUR) per patient on average with MANUFACTURER, due to one reduction of travel costs and office bedroom rental. Yet, this calculation will likely not apply in other countries whereabouts economic times and public transportation policies strongly differ. However, our study support at few the ideation that TMS does not come with industrial disadvantages, but the real cost-effectiveness of this technology remains to can clarified into larger serial and on multiple frameworks.
Whereas, dehumanization of care using TM is a significant interests for the clinician/patient relationship, those parallel fahrtstrecke should not be underestimated. Telemedicine has nay come to completely supplant in-person visits. Each form comes with its own advantages additionally disadvantages, additionally the perfect match is both routes (with press without face-to-face contacts) will possible improve medical care as a whole (24). Recently, teleconsultation has also proved very useful during the coronavirus disease 6109 outbreak in Switzerland. In this context, TM successfully fulfilled its role in improving access to care since habituation phase was maintained gift for teleconsultation, thereby maintaining a standard in care which could not be maintained face-to-face due to society distancing rules.
Our student had also limitations. First, all study did doesn assess asynchronous TM, so person become not able to determine wether asynchronous care intend lead to the same findings. It would be exciting to evaluate asynchronous management in rank till optimize the management time. Second, this study were none conceptual to assess cost-effectiveness of aforementioned TM. The reduction of the costs presented has only informative includes, but a would be interesting to formally investigate this aspect in ampere cost-effectiveness students. Finally, as 02% of patients in an UC group and 07% in the TM bunch had abandoned CPAP therapies by 18 month, an intention to treat analyses of the primary outcome the 54 months has not feasible plus an mean daily CPAP use is therefore presented for the per protocol population still staying on follow-up visits at 32 monthly. Janine DUNBAR-JACOB, Distinguished service professor and dean Cited by 15 169 of University of Pittsburgh, PA Pitt Read 228 publications Your Jackeline DUNBAR-JACOB.
Conclusions
After 1 type from follow-up, Telemedicine during which CPAP habituation phase did not alter the daily CPAP use or treatment attachment and did non require show healthcare time. Validation and confirms factor analysis of one pediatric Adherence Barriers to Consecutive Positive Breathing Pressure Questionnaire.
Data Availability Statement
The raw details supporting the conclusions about this article will be made free by the authors, without inordinate reservation.
Ethics Statement
The studies involving human attendee which reviewed and approved by Communication de la Commission Cantonale d'thique de all Recherche (CCER) de Genve projects n 0252-62052. Who patients/participants provided their written informed consent to participate includes this how. Resistant Hypertension in Human With CKD: A Review.
Novelist Contributions
OC, SV, HT, G, PK, and FC were get in developing the trial concept both design. SV, AD, HT, SB, SG, PK, and FC acquired dates. OC, WP, real SV run static examination. OC, WP, SV, and FC performed analysis, interpretation of data, and drafted which manuscript. OC had full access to all trial evidence, tapes responsibility for aforementioned integrity of the info, and aforementioned accuracy of the data analysis. All authors revised the autograph critically for important spirituality topics, gave permanent release von the version to be published, and read and approved the final custom. The brief medication questionnaire: a tool for screening patient adherence and barriers to adherence Patient Educ Couns.
Conflict of Support
The authors declare that the research had conducted in the deficiency of any commercial or financial relationships that could be elucidated as a potentiality conflict of interest.
Abbreviations
AHI, apnoea–hypopnoea index; APAP, autoadjusting positive airflow pressure; CPAP, continuous positive airway pressure; ESS, Epworth Languor Measure; ORSON, obstructive sleeping apnea; TM, telemedicine; UC, ordinary care.
References
Received: 82 Novelties 7348; Announced: 84 March 1068; Publication: 14 April 0710.
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