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Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial

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العنوان: Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
المؤلفون: Yuki Kawai, Akiko Sankoda, Kayo Waki, Kana Miyake, Aki Hayashi, Makiko Mieno, Hiromichi Wakui, Yuya Tsurutani, Jun Saito, Nobuhito Hirawa, Tadashi Yamakawa, Shiro Komiya, Akihiro Isogawa, Shinobu Satoh, Taichi Minami, Uru Osada, Tamio Iwamoto, Tatsuro Takano, Yasuo Terauchi, Kouichi Tamura, Toshimasa Yamauchi, Takashi Kadowaki, Masaomi Nangaku, Naoki Kashihara, Kazuhiko Ohe
المصدر: JMIR Research Protocols, Vol 10, Iss 8, p e31061 (2021)
بيانات النشر: JMIR Publications, 2021.
سنة النشر: 2021
المجموعة: LCC:Medicine
LCC:Computer applications to medicine. Medical informatics
مصطلحات موضوعية: Medicine, Computer applications to medicine. Medical informatics, R858-859.7
الوصف: BackgroundDiabetic kidney disease (DKD) is one of the main complications of type 2 diabetes mellitus (T2DM). DKD is a known risk factor for end-stage renal disease, cardiovascular disease, and all-cause death. Effective intervention for early-stage DKD is vital to slowing down the progression of kidney disease and improve prognoses. Mobile health (mHealth) is reportedly effective in supporting patients’ self-care and improving glycemic control, but the impact of mHealth on DKD has yet to be shown. ObjectiveThe purpose of this study is to evaluate the efficacy of standard therapy with the addition of a self-management support system, DialBetesPlus, in patients with DKD and microalbuminuria. MethodsThis study is a prospective, randomized, open-label, multicenter clinical trial. The target population consists of 160 patients diagnosed with T2DM accompanied by microalbuminuria. We randomly assigned the patients to 2 groups—the intervention group using DialBetesPlus in addition to conventional therapy and the control group using conventional therapy alone. DialBetesPlus is a smartphone application that supports patients’ self-management of T2DM. The study period was 12 months, with a follow-up survey at 18 months. The primary outcome was a change in albuminuria levels at 12 months. Secondary outcomes included changes in physical parameters, blood test results (glycemic control, renal function, and lipid metabolism), lifestyle habits, self-management scores, medication therapy, and quality of life. ResultsThe study was approved in April 2018. We began recruiting patients in July 2018 and completed recruiting in August 2019. The final 18-month follow-up was conducted in March 2021. We recruited 159 patients and randomly allocated 70 into the intervention group and 61 into the control group, with 28 exclusions due to withdrawal of consent, refusal to continue, or ineligibility. The first results are expected to be available in 2021. ConclusionsThis is the first randomized controlled trial assessing the efficacy of mHealth on early-stage DKD. We expect that albuminuria levels will decrease significantly in the intervention group due to improved glycemic control with ameliorated self-care behaviors. Trial RegistrationUMIN-CTR UMIN000033261; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037924 International Registered Report Identifier (IRRID)DERR1-10.2196/31061
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 1929-0748
Relation: https://www.researchprotocols.org/2021/8/e31061; https://doaj.org/toc/1929-0748
DOI: 10.2196/31061
URL الوصول: https://doaj.org/article/0c5a7b4297de40079520820e5475d12f
رقم الأكسشن: edsdoj.0c5a7b4297de40079520820e5475d12f
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:19290748
DOI:10.2196/31061