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

被引:12
作者
Kawai, Yuki [1 ,2 ]
Sankoda, Akiko [1 ]
Waki, Kayo [1 ,3 ]
Miyake, Kana [1 ,3 ]
Hayashi, Aki [1 ]
Mieno, Makiko [4 ]
Wakui, Hiromichi [2 ]
Tsurutani, Yuya [5 ]
Saito, Jun [5 ]
Hirawa, Nobuhito [6 ]
Yamakawa, Tadashi [7 ]
Komiya, Shiro [2 ]
Isogawa, Akihiro [8 ]
Satoh, Shinobu [9 ]
Minami, Taichi [10 ]
Osada, Uru [10 ]
Iwamoto, Tamio [11 ]
Takano, Tatsuro [12 ]
Terauchi, Yasuo [13 ]
Tamura, Kouichi [2 ]
Yamauchi, Toshimasa [3 ]
Kadowaki, Takashi [14 ,15 ]
Nangaku, Masaomi [16 ]
Kashihara, Naoki [17 ]
Ohe, Kazuhiko [1 ]
机构
[1] Univ Tokyo Hosp, Dept Planning Informat & Management, Tokyo, Japan
[2] Yokohama City Univ, Grad Sch Med, Dept Med Sci & Cardiorenal Med, Yokohama, Kanagawa, Japan
[3] Univ Tokyo, Grad Sch Med, Dept Diabet & Metab Dis, Tokyo, Japan
[4] Jichi Med Univ, Ctr Informat, Dept Med Informat, Shimotsuke, Tochigi, Japan
[5] Yokohama Rosai Hosp, Endocrinol & Diabet Ctr, Yokohama, Kanagawa, Japan
[6] Yokohama City Univ, Med Ctr, Dept Nephrol & Hypertens, Yokohama, Kanagawa, Japan
[7] Yokohama City Univ, Med Ctr, Dept Endocrinol & Diabet, Yokohama, Kanagawa, Japan
[8] Mitsui Mem Hosp, Div Diabet, Tokyo, Japan
[9] Chigasaki Municipal Hosp, Dept Endocrinol & Metab, Chigasaki, Kanagawa, Japan
[10] Saiseikai Yokohamashi Nanbu Hosp, Dept Diabet & Endocrinol, Yokohama, Kanagawa, Japan
[11] Saiseikai Yokohamashi Nanbu Hosp, Dept Nephrol & Hypertens, Yokohama, Kanagawa, Japan
[12] Fujisawa City Hosp, Dept Diabet & Endocrinol, Fujisawa, Kanagawa, Japan
[13] Yokohama City Univ, Grad Sch Med, Dept Endocrinol & Metab, Yokohama, Kanagawa, Japan
[14] Univ Tokyo, Grad Sch Med, Dept Prevent Diabet & Lifestyle Related Dis, Tokyo, Japan
[15] Toranomon Gen Hosp, Tokyo, Japan
[16] Univ Tokyo, Grad Sch Med, Div Nephrol & Endocrinol, Tokyo, Japan
[17] Kawasaki Med Sch, Dept Nephrol & Hypertens, Kurashiki, Okayama, Japan
来源
JMIR RESEARCH PROTOCOLS | 2021年 / 10卷 / 08期
关键词
diabetic kidney disease; microalbuminuria; albuminuria; diabetes mellitus; self-management support system; mHealth; randomized controlled trial; diabetes; kidney; chronic disease; support; self-management; efficacy; protocol; therapy; intervention; self-care; behavior; QUALITY-OF-LIFE; ALBUMINURIA; MICROALBUMINURIA; VALIDITY; AUDIT; CARE;
D O I
10.2196/31061
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
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.
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页数:12
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