Kalp yetersizliği hastalarının bakımında uzaktan hasta izleminin klinik sonuçlarının değerlendirilmesi
Küçük Resim Yok
Dosyalar
Tarih
2021
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Ege Üniversitesi, Tıp Fakültesi
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
Amaç: KY hastalarının takip ve yönetiminde akıllı telefon uygulaması üzerinden ağırlık, kalp hızı ve kan basıncı uzaktan izleminin; KY nedeniyle ölüm, acil servis başvurusu ve hastane yatışını azaltıp azaltmadığını saptamak ve bu sistemin kullanılabilirliğini değerlendirmek
Metot: Prospektif, randomize kontrollü, açık etiketli, tek merkezli çalışma olarak planlandı. En az 6 aydır düşük ejeksiyon fraksiyonlu KY tanısı olan, SolV EF ≤ %35, tedavi gerektiren KOAH ve hemodiyaliz gerektiren böbrek yetersizliği olmayan hastalar dışlama kriterlerine göre çalışmaya alındı. 158 hasta yaşa göre eşleştirilmiş çift tasarımında rastgele olarak, olağan bakım grubu (OBG) ve telemonitörizasyon grubu (TMG) olmak üzere iki kola randomize edildi. Primer sonlanım noktası KY nedeniyle ölüm, acil servis başvurusu, hastane yatışı birleşik sonucu olarak alındı. TMG’de takibe düzenli devam eden hastalarda yaşam konforundaki değişikliği saptamak için hastalara aynı mobil uygulama üzerinden MHFQL ölçeğini doldurmaları istendi. TMG’de ilk 90 günde takibi bırakan hastaların telemonitörizasyonu bırakma sebeplerini öğrenmek için açık uçlu telefon anketi yapıldı.
Bulgular: Ortalama(±sd) yaş ve takip süresi sırası ile 52,4(±10,4) yıl ve 288,9 (±37) gündü. Primer sonlanım noktası açısından TMG ve OBG arasında anlamlı fark izlenmedi (95% CI 0.61-1.89, Log rank p=0.7924, HR:1.07). TMG’de hastaların %38’i (n=30) ilk 90 günde telemonitörize takibi bıraktı. %37 (n=11) oranla takibi bırakmanın en sık sebebi uzaktan takip sisteminin yarattığı anksiyete artışıydı, bunu %23(n=7) oran ile sosyal destek yetersizliği takip etti. TM izlemi bırakan grup (TBG n=30) ve düzenli devam eden grubun (TDG n=49) tüm bazal karakteristik verilerinde anlamlı farklılık izlenmedi. Primer sonlanım açısından OBG, TDG, TBG arasında anlamlı fark izlenmedi. (95% CI OBG’ye göre TDG ve TBG sırasıyla HR:0.83 0.43-1.59, HR:1,48 0,39-3,14). MLHFQ ölçeğini yanıtlayan 29 TDG hastada TM öncesi ve sonrasında fiziksel fonksiyon, emosyonel durum, toplam skorda istatiksel anlamlı farklılık izlenmedi. (Sırasıyla 95% CI P = 0,6787, P = 0,4115, P = 0,6752)
Sonuç: Akıllı telefonla uzaktan izleme destekli bakım yaklaşımı hastaların klinik durumunda ölçülebilir bir iyileştirme göstermedi. Çalışma birincil sonuçlar açısından istatistiksel olarak anlamlı farklılıklar yaratmamış olsa da hem yeni farklı bakış açıları geliştirmeyi, hem de daha fazla araştırmayı teşvik edecek kadar cesaret vericidir.
Objective: In the follow-up and management of HF patients, weight, heart rate and blood pressure monitoring via smartphone application; To determine whether it reduces death, emergency service admissions and hospitalization due to HF and to evaluate the usability of this system. Method: This study was planned as a prospective, randomized controlled open label, single center cohort study. Patients with a diagnosis of HFrEF for at least 6 months with optimal medical treatment were included in the study. Patients with LVEF above 35%, patients with COPD requiring treatment, and patients with renal failure requiring hemodialysis were excluded from the study. 158 patients were randomized into two arms in an age-matched pair design. (usual care (UC) and telemonitoring (TM) groups). The primary endpoint was death due to HF, emergency service admission, and hospitalization composite result. Patients in the TM group were asked to fill in the MHFQL scale to detect the change in comfort of life in patients who were regularly followed up. An open-ended telephone questionnaire was conducted to find out the reasons for discontinuing telemonitoring of patients who stopped following TM follow-up in the first 90 days. Results: The mean (± sd) age and follow-up time were 52.4 (± 10.4) years and 288.9 (± 37) days, respectively. No significant difference was observed between TM and UC in patients who reached the primary endpoint (95% CI 0.61-1.89, Log rank p = 0.7924, HR: 1.07). 38% (n = 30) of the patients in the TM group stopped telemonitored follow-up in the first 90 days. The most common reason for discontinuing this follow-up was the increase in anxiety caused by the remote monitoring system (37%, n = 11). This was followed by insufficient social support (23%, n = 7). There was no significant difference in the baseline characteristics of the group that left the TM follow-up (TMS n = 30) and the group that continued regularly (TMC n = 49). There was no significant difference between UC, TMC and TMS patients who reached the primary endpoint. (According to 95% CI UC, TMC and TMS HR: 0.83 0.43-1.59, HR: 1.48 0.39-3.14, respectively). In 29 TMC patients who answered the MLHFQ scale, there was no statistically significant change in physical function, emotional state, and total score before and after TM follow-up. (Respectively, 95% CI P = 0.6787, P = 0.4115, P = 0.6752) Conclusion: The smartphone remote monitoring assisted care approach did not show any measurable improvement in the clinical condition of the patients. Although the study did not create statistically significant differences in terms of primary results, it is encouraging enough to both develop new different perspectives and support further research.
Objective: In the follow-up and management of HF patients, weight, heart rate and blood pressure monitoring via smartphone application; To determine whether it reduces death, emergency service admissions and hospitalization due to HF and to evaluate the usability of this system. Method: This study was planned as a prospective, randomized controlled open label, single center cohort study. Patients with a diagnosis of HFrEF for at least 6 months with optimal medical treatment were included in the study. Patients with LVEF above 35%, patients with COPD requiring treatment, and patients with renal failure requiring hemodialysis were excluded from the study. 158 patients were randomized into two arms in an age-matched pair design. (usual care (UC) and telemonitoring (TM) groups). The primary endpoint was death due to HF, emergency service admission, and hospitalization composite result. Patients in the TM group were asked to fill in the MHFQL scale to detect the change in comfort of life in patients who were regularly followed up. An open-ended telephone questionnaire was conducted to find out the reasons for discontinuing telemonitoring of patients who stopped following TM follow-up in the first 90 days. Results: The mean (± sd) age and follow-up time were 52.4 (± 10.4) years and 288.9 (± 37) days, respectively. No significant difference was observed between TM and UC in patients who reached the primary endpoint (95% CI 0.61-1.89, Log rank p = 0.7924, HR: 1.07). 38% (n = 30) of the patients in the TM group stopped telemonitored follow-up in the first 90 days. The most common reason for discontinuing this follow-up was the increase in anxiety caused by the remote monitoring system (37%, n = 11). This was followed by insufficient social support (23%, n = 7). There was no significant difference in the baseline characteristics of the group that left the TM follow-up (TMS n = 30) and the group that continued regularly (TMC n = 49). There was no significant difference between UC, TMC and TMS patients who reached the primary endpoint. (According to 95% CI UC, TMC and TMS HR: 0.83 0.43-1.59, HR: 1.48 0.39-3.14, respectively). In 29 TMC patients who answered the MLHFQ scale, there was no statistically significant change in physical function, emotional state, and total score before and after TM follow-up. (Respectively, 95% CI P = 0.6787, P = 0.4115, P = 0.6752) Conclusion: The smartphone remote monitoring assisted care approach did not show any measurable improvement in the clinical condition of the patients. Although the study did not create statistically significant differences in terms of primary results, it is encouraging enough to both develop new different perspectives and support further research.
Açıklama
Anahtar Kelimeler
Kalp Yetersizliği, Telemonitörizasyon, Teletıp, Akıllı Telefon Uygulaması, m-Sağlık, Heart Failure, Telemonitoring, Telemedicine, Smartphone Application, m-Health
