Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol f...
Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
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Author / Creator
Kawai, Yuki , Sankoda, Akiko , Waki, Kayo , Miyake, Kana , Hayashi, Aki , Mieno, Makiko , Wakui, Hiromichi , Tsurutani, Yuya , Saito, Jun , Hirawa, Nobuhito , Yamakawa, Tadashi , Komiya, Shiro , Isogawa, Akihiro , Satoh, Shinobu , Minami, Taichi , Osada, Uru , Iwamoto, Tamio , Takano, Tatsuro , Terauchi, Yasuo , Tamura, Kouichi , Yamauchi, Toshimasa , Kadowaki, Takashi , Nangaku, Masaomi , Kashihara, Naoki and Ohe, Kazuhiko
Publisher
Toronto: JMIR Publications
Journal title
Language
English
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Publisher
Toronto: JMIR Publications
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Scope and Contents
Contents
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...
Alternative Titles
Full title
Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
Authors, Artists and Contributors
Author / Creator
Sankoda, Akiko
Waki, Kayo
Miyake, Kana
Hayashi, Aki
Mieno, Makiko
Wakui, Hiromichi
Tsurutani, Yuya
Saito, Jun
Hirawa, Nobuhito
Yamakawa, Tadashi
Komiya, Shiro
Isogawa, Akihiro
Satoh, Shinobu
Minami, Taichi
Osada, Uru
Iwamoto, Tamio
Takano, Tatsuro
Terauchi, Yasuo
Tamura, Kouichi
Yamauchi, Toshimasa
Kadowaki, Takashi
Nangaku, Masaomi
Kashihara, Naoki
Ohe, Kazuhiko
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Primary Identifiers
Record Identifier
TN_cdi_doaj_primary_oai_doaj_org_article_0c5a7b4297de40079520820e5475d12f
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_doaj_primary_oai_doaj_org_article_0c5a7b4297de40079520820e5475d12f
Other Identifiers
ISSN
1929-0748
E-ISSN
1929-0748
DOI
10.2196/31061