Kimihiko Murase1, Kiminobu Tanizawa2, Takuma Minami2, Takeshi Matsumoto2,3, Ryo Tachikawa2,4, Naomi Takahashi1, Toru Tsuda5, Yoshiro Toyama6, Motoharu Ohi6, Toshiki Akahoshi7, Yasuhiro Tomita8, Koji Narui8, Hiroshi Nakamura9, Tetsuro Ohdaira10, Hiroyuki Yoshimine11, Tomomasa Tsuboi12, Yoshihiro Yamashiro13, Shinichi Ando14, Takatoshi Kasai15, Hideo Kita16, Koichiro Tatsumi17, Naoto Burioka18, Keisuke Tomii4, Yasuhiro Kondoh19, Hirofumi Takeyama1, Tomohiro Handa20, Satoshi Hamada20, Toru Oga2, Takeo Nakayama21, Tetsuo Sakamaki22, Satoshi Morita23, Tomohiro Kuroda24, Toyohiro Hirai2, Kazuo Chin1. 1. Department of Respiratory Care and Sleep Control Medicine. 2. Department of Respiratory Medicine. 3. Department of Respiratory Medicine, Saiseikai Noe Hospital, Osaka, Japan. 4. Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. 5. Sleep Center, Kirigaoka Tsuda Hospital, Kitakyusyu, Japan. 6. Sleep Medical Center, Osaka Kaisei Hospital, Osaka, Japan. 7. Shinjuku Sleep and Respiratory Clinic, Tokyo, Japan. 8. Sleep Center, Toranomon Hospital, Tokyo, Japan. 9. Nakamura Clinic, Urazoe, Japan. 10. Department of Respiratory Medicine, Nishi-Niigata Chuo National Hospital, Niigata, Japan. 11. Inoue Hospital, Shunkaikai, Nagasaki, Japan. 12. Department of Respiratory Medicine, National Hospital Organization Minami Kyoto Hospital, Joyo, Japan. 13. Ureshinogaoka Samaritan Hospital, Okinawa, Japan. 14. Sleep Apnea Center, Kyushu University Hospital, Fukuoka, Japan. 15. Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan. 16. Department of Respiratory Medicine, Takatsuki Red Cross Hospital, Takatsuki, Japan. 17. Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan. 18. Department of Pathobiological Science and Technology, School of Health Science, Tottori University Faculty of Medicine, Tottori, Japan. 19. Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Japan. 20. Department of Advanced Medicine for Respiratory Failure, and. 21. Department of Health Informatics, Kyoto University School of Public Health, Kyoto, Japan. 22. System Integration Center, Gunma University, Gunma, Japan; and. 23. Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 24. Division of Medical Information Technology and Administration Planning, Kyoto University Hospital, Kyoto, Japan.
Abstract
Rationale: The effects of telemedicine on adherence in patients with obstructive sleep apnea with long-term continuous positive airway pressure (CPAP) use have never been investigated. Objectives: To examine effects of a telemedicine intervention on adherence in long-term CPAP users. Methods: In a prospective, randomized, multicenter noninferiority trial conducted in 17 sleep centers across Japan, patients who had used CPAP for >3 months and were receiving face-to-face follow-up by physicians every 1 or 2 months were randomized by a coordinating center in a blind manner to the following three groups: 1) follow-up every 3 months accompanied by a monthly telemedicine intervention (telemedicine group: TM-group), 2) follow-up every 3 months (3-month group: 3M-group), or 3) monthly follow-up (1-month group: 1M-group). Each group was followed up for 6 months. The change in percentage of days with ≥4 h/night of CPAP use from baseline to the end of the study period was evaluated. A decline of ≥5% from baseline was considered deterioration of adherence. Noninferiority of TM- and 3M-groups compared with the 1M-group according to the number of patients with deterioration of adherence was evaluated with the Farrington and Manning test (noninferiority margin 15%). Results: A total of 483 patients were analyzed (median duration of CPAP use, 29 [interquartile range, 12-71] mo), and deterioration of adherence was found in 41 of 161 (25.5%), 55 of 166 (33.1%), and 35 of 156 (22.4%) patients in the TM-, 3M-, and 1M-groups, respectively. The noninferiority of the TM-group compared with the 1M-group was verified (difference in percentage of patients with adherence deterioration, 3.0%; 95% confidence interval [CI], -4.8% to 10.9%; P < 0.01). Conversely, the 3M-group did not show noninferiority to the 1M-group (percentage difference, 10.7%; 95% CI, 2.6% to 18.8%; P = 0.19). In the stratified analysis, adherence in TM- and 1M-group patients with poor adherence at baseline improved (TM: 45.8% ± 18.2% to 57.3% ± 24.4%; P < 0.01; 1M: 43.1% ± 18.5% to 53.6% ± 24.3%; P < 0.01), whereas that of the 3M-group did not (39.3% ± 20.8% to 39.8% ± 24.8%; P = 0.84).Conclusions: Intensive telemedicine support could help to optimize CPAP adherence even after long-term CPAP use.Clinical trial registered with www.umin.ac.jp/ctr/index.htm (trial number: UMIN000023118).
RCT Entities:
Rationale: The effects of telemedicine on adherence in patients with obstructive sleep apnea with long-term continuous positive airway pressure (CPAP) use have never been investigated. Objectives: To examine effects of a telemedicine intervention on adherence in long-term CPAP users. Methods: In a prospective, randomized, multicenter noninferiority trial conducted in 17 sleep centers across Japan, patients who had used CPAP for >3 months and were receiving face-to-face follow-up by physicians every 1 or 2 months were randomized by a coordinating center in a blind manner to the following three groups: 1) follow-up every 3 months accompanied by a monthly telemedicine intervention (telemedicine group: TM-group), 2) follow-up every 3 months (3-month group: 3M-group), or 3) monthly follow-up (1-month group: 1M-group). Each group was followed up for 6 months. The change in percentage of days with ≥4 h/night of CPAP use from baseline to the end of the study period was evaluated. A decline of ≥5% from baseline was considered deterioration of adherence. Noninferiority of TM- and 3M-groups compared with the 1M-group according to the number of patients with deterioration of adherence was evaluated with the Farrington and Manning test (noninferiority margin 15%). Results: A total of 483 patients were analyzed (median duration of CPAP use, 29 [interquartile range, 12-71] mo), and deterioration of adherence was found in 41 of 161 (25.5%), 55 of 166 (33.1%), and 35 of 156 (22.4%) patients in the TM-, 3M-, and 1M-groups, respectively. The noninferiority of the TM-group compared with the 1M-group was verified (difference in percentage of patients with adherence deterioration, 3.0%; 95% confidence interval [CI], -4.8% to 10.9%; P < 0.01). Conversely, the 3M-group did not show noninferiority to the 1M-group (percentage difference, 10.7%; 95% CI, 2.6% to 18.8%; P = 0.19). In the stratified analysis, adherence in TM- and 1M-group patients with poor adherence at baseline improved (TM: 45.8% ± 18.2% to 57.3% ± 24.4%; P < 0.01; 1M: 43.1% ± 18.5% to 53.6% ± 24.3%; P < 0.01), whereas that of the 3M-group did not (39.3% ± 20.8% to 39.8% ± 24.8%; P = 0.84).Conclusions: Intensive telemedicine support could help to optimize CPAP adherence even after long-term CPAP use.Clinical trial registered with www.umin.ac.jp/ctr/index.htm (trial number: UMIN000023118).
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