Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
| Autor: | Makiko Mieno, Toshimasa Yamauchi, Yuya Tsurutani, Uru Nezu Osada, Akiko Sankoda, Masaomi Nangaku, Akihiro Isogawa, Yuki Kawai, Taichi Minami, Aki Hayashi, Shiro Komiya, Yasuo Terauchi, Nobuhito Hirawa, Hiromichi Wakui, Tamio Iwamoto, Tatsuro Takano, Kazuhiko Ohe, Kayo Waki, Kana Miyake, Tadashi Yamakawa, Jun Saito, Shinobu Satoh, Takashi Kadowaki, Kouichi Tamura, Naoki Kashihara |
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| Rok vydání: | 2021 |
| Předmět: |
kidney
self-management medicine.medical_specialty microalbuminuria efficacy albuminuria law.invention Randomized controlled trial Quality of life law Internal medicine Diabetes mellitus self-care Protocol medicine intervention Glycemic therapy support diabetes behavior business.industry General Medicine medicine.disease diabetic kidney disease Clinical trial self-management support system mHealth diabetes mellitus randomized controlled trial Albuminuria Microalbuminuria medicine.symptom business chronic disease Kidney disease |
| Zdroj: | JMIR Research Protocols |
| ISSN: | 1929-0748 |
| DOI: | 10.2196/31061 |
| Popis: | Background Diabetic 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. Objective The 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. Methods This 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. Results The 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. Conclusions This 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 Registration UMIN-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 |
| Databáze: | OpenAIRE |
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