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

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 k...

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Autores principales: 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, Ohe, Kazuhiko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408755/
https://www.ncbi.nlm.nih.gov/pubmed/34402802
http://dx.doi.org/10.2196/31061
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author 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
Ohe, Kazuhiko
author_facet 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
Ohe, Kazuhiko
author_sort Kawai, Yuki
collection PubMed
description 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
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spelling pubmed-84087552021-09-14 Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial 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 Ohe, Kazuhiko JMIR Res Protoc Protocol 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 JMIR Publications 2021-08-17 /pmc/articles/PMC8408755/ /pubmed/34402802 http://dx.doi.org/10.2196/31061 Text en ©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. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 17.08.2021. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
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
Ohe, Kazuhiko
Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
title Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
title_full Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
title_fullStr Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
title_full_unstemmed Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
title_short Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial
title_sort efficacy of the self-management support system dialbetesplus for diabetic kidney disease: protocol for a randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408755/
https://www.ncbi.nlm.nih.gov/pubmed/34402802
http://dx.doi.org/10.2196/31061
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