Diabetic nephropathy self-care -
The study is being carried out in compliance with the Declaration of Helsinki. This protocol and informed consent forms were approved by the Research Ethics Committee of The University of Tokyo Graduate School of Medicine and affiliated institutions.
This study was registered in the University Hospital Medical Information Network Clinical Trials Registry UMIN [ 34 ]. All participants are included after providing their signed and informed consent to participate in the trial.
The participants are also informed of their right to withdraw from the study at any time. After the study concludes, data will be accessible by study groups for analysis and dissemination. All results of any analyses will be presented at major national and international scientific conferences and submitted for peer-reviewed journals of international repute and visibility.
We will compare changes in albuminuria levels, physical parameters, blood tests, and nutritional intake between the intervention and control groups.
These will be analyzed using the 2-tailed t test or Mann-Whitney U test, as appropriate. Changes in J-SDSCA, MMAS-8, and JP-ADDQoL scores will also be analyzed using the Mann-Whitney U test.
We will compare the proportion of hypoglycemia during the study in the intervention group to the proportion in the control group using Fisher's exact test. Statistical analyses will be performed using SAS version 9.
The study was approved in April We started recruiting patients in July and completed recruitment in August The final week follow-up was completed in April The first results are expected to be available later in We recruited participants with written informed consent Figure 1.
No participants were excluded due to an inability to use DialBetesPlus. A participant in the control group and another in the intervention group were also excluded after randomization due to the late discovery of ineligibility.
The baseline characteristics of the remaining patients are shown in Multimedia Appendix 1. Data for continuous variables are expressed as mean SD or median IQR. Table 2 displays the baseline demographic characteristics of the remaining participants, excluding the 2 late-discovered ineligible participants.
The baseline characteristics showed no significant differences between the control group and the intervention group. The beneficial effect of mHealth on T2DM in improving glycemic control has been widely reported [ 14 , 35 , 36 ].
However, the impact of mHealth on DKD, one of the major microvascular complications of T2DM, has not yet been shown. To our knowledge, this is the first study evaluating the efficacy of mHealth on DKD in which microalbuminuria is the primary endpoint and eGFR is one of the secondary endpoints.
Furthermore, because we followed participants for 6 months after the intervention, this study enables us to assess if the novel smartphone-based self-management support system DialBetesPlus can discernibly modify self-care behaviors in T2DM patients.
DialBetesPlus is an improved version of the previously reported DialBetics [ 17 ]. Additionally, patients can receive feedback on their daily and weekly diets to comprehensively look at their lifestyles.
While recent meta-analysis on mHealth shows that bidirectional communication between patients and health providers is indispensable for better glycemic control outcomes of T2DM patients [ 35 , 37 ], DialBetesPlus features a completely automated feedback system using the algorithm of DialBetics.
Even though patients who used DialBetics cannot contact their health providers directly via DialBetics, a previous study showed significant reductions in HbA 1c 0. We hypothesize that albuminuria levels will significantly decrease in the intervention group compared to the control group due to improved self-care behaviors and glycemic control.
This study may broaden the potential of mHealth to prevent the progression of T2DM microvascular complications. The MMAS-8 scoring and coding presented in the article were done using the electronic Morisky Widget MMAS-8 Software. Use of the Morisky Widget MMAS-8 software, copyright registration number TX , is protected by US copyright laws.
Permission for the use of the Morisky Widget MMAS-8 software is required and was obtained for this research. A license agreement is available from MMAS Research LLC NE 20th St Bellevue, WA , USA; strubow morisky. The ADDQoL was applied in the study with the consent and license received from the author, Clare Bradley Health Psychology Research Unit, Royal Holloway, University of London [ 38 ].
Finally, we would like to thank the participants, physicians see Multimedia Appendix 2 , and other health care professionals at the 8 participating institutions. This research was supported by AMED grant JP19ek KW, YT, KT, TY, TK, MN, NK, and KO contributed to the design and implementation of the study.
YK, AS, KW, KM, AH, MM, HW, YT, SJ, NH, TY, SK, AI, SS, TM, UO, TI, and TT conceived and planned the study. YK, AS, and KW drafted the manuscript. KW is the principal investigator of the study and was responsible for conducting the study overall.
All authors commented on the manuscript and approved the final version. The author s disclose receipt of the external financial support for the research, authorship, and publication of this article: In addition to the AMED grant, this research was supported by NTT DOCOMO Inc.
and Nihon Chouzai Co, Ltd. KM was a member of a cooperative program between the University of Tokyo and NTT DOCOMO. Edited by G Eysenbach; submitted org , org, as well as this copyright and license information must be included.
Skip to Main Content Skip to Footer. Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial Authors of this article: Yuki Kawai 1, 2 ; Akiko Sankoda 2 ; Kayo Waki 2, 3 ; Kana Miyake 2, 3 ; Aki Hayashi 2 ; Makiko Mieno 4 ; Hiromichi Wakui 1 ; Yuya Tsurutani 5 ; Jun Saito 5 ; Nobuhito Hirawa 6 ; Tadashi Yamakawa 7 ; Shiro Komiya 1 ; Akihiro Isogawa 8 ; Shinobu Satoh 9 ; Taichi Minami 10 ; Uru Osada 10 ; Tamio Iwamoto 11 ; Tatsuro Takano 12 ; Yasuo Terauchi 13 ; Kouichi Tamura 1 ; Toshimasa Yamauchi 3 ; Takashi Kadowaki 14, 15 ; Masaomi Nangaku 16 ; Naoki Kashihara 17 ; Kazuhiko Ohe 2.
Article Authors Cited by 5 Tweetations 2 Metrics. Corresponding Author: Kayo Waki, MD, MPH, PhD Department of Planning, Information and Management, University of Tokyo Hospital Hongo, Bunkyo-ku Tokyo, Japan Phone: 81 3 Fax 3 Email: kwaki-tky m.
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.
List of trial institutions. The University of Tokyo Hospital Yokohama City University Hospital Yokohama City University Medical Center Yokohama Rosai Hospital Saiseikai Yokohamashi Nanbu Hospital Fujisawa City Hospital Chigasaki Municipal Hospital Mitsui Memorial Hospital Textbox 1.
Inclusion and exclusion criteria. Inclusion criteria Diagnosed with T2DM HbA 1c 6. Table 1. Assessment and follow-up schedule. b MMAS 8-item Morisky Adherence Scale. c JP-ADDQoL: Japanese version of the Audit of Diabetes-Dependent Quality of Life. Table 2. Baseline patient characteristics. b HbA 1c : glycated hemoglobin.
c LDL-C: low-density lipoprotein cholesterol. d HDL-C: high-density lipoprotein cholesterol. e eGFR: estimated glomerular filtration rate.
f UACR: urine albumin-to-creatinine ratio. g One case had a missing value. Multimedia Appendix 1 Patient characteristics prior to randomization. DOCX File , 19 KB. Multimedia Appendix 2 Physicians involved in participant recruitment.
References IDF Diabetes Atlas, 8th Edition. Brussels: International Diabetes Federation; Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet May 16; Lower estimated glomerular filtration rate and higher albuminuria are associated with all-cause and cardiovascular mortality.
A collaborative meta-analysis of high-risk population cohorts. Patient receiving nursing home care visits for the management of diabetes. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. gov identifier NCT number : NCT Layout table for location information Switzerland University of Lausanne Hospitals Lausanne, Vaud, Switzerland, University of Applied Sciences of Western Switzerland. Layout table for investigator information Study Director: Maya Shaha, PhD, RN University of Lausanne- Faculty of Biology and Medicine, Institut universitaire de formation et de recherche en soins.
More Information. Publications automatically indexed to this study by ClinicalTrials. gov Identifier NCT Number : Helou N, Talhouedec D, Shaha M, Zanchi A. The impact of a multidisciplinary self-care management program on quality of life, self-care, adherence to anti-hypertensive therapy, glycemic control, and renal function in diabetic kidney disease: A Cross-over Study Protocol.
BMC Nephrol. doi: Keywords provided by Nancy Helou, University of Applied Sciences of Western Switzerland:. Diabetic nephropathies Nursing Multidisciplinary Self-care Quality of Life. Layout table for MeSH terms Kidney Diseases Diabetic Nephropathies Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases.
For Patients and Families For Researchers For Study Record Managers. Home RSS Feeds Site Map Terms and Conditions Disclaimer Customer Support. Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA. gov HHS Vulnerability Disclosure U. National Library of Medicine U.
National Institutes of Health U. Department of Health and Human Services. Recruitment Status : Completed First Posted : October 23, Last Update Posted : May 18, Diabetic Kidney Disease. Behavioral: Self-care management program.
Not Applicable. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Impact of a Multidisciplinary Self-care Management Program on Quality of Life, Self-care Behavior, Adherence to the Anti-hypertensive Treatment, Glycemic Control, and Renal Function in Adults Living With Diabetic Kidney Disease.
Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Behavioral: Self-care management program The self-care management consists of the usual care with an additional multidisciplinary self-management program that includes additional home and clinic visits and telephone follow-ups made by the self-care management nurse and clinic visits to the dietician.
Active Comparator: Sequence BAAB Patients will receive the multidisciplinary self-management program for 3 months. The procedure often uses an imaging device, such as an ultrasound transducer, to guide the needle.
Diabetic nephropathy usually is diagnosed during the regular testing that's part of managing diabetes. Get tested every year if you have type 2 diabetes or have had type 1 diabetes for more than five years. Our caring team of Mayo Clinic experts can help you with your diabetic nephropathy kidney disease -related health concerns Start Here.
The first step in treating diabetic nephropathy is to treat and control diabetes and high blood pressure. Treatment includes diet, lifestyle changes, exercise and prescription medicines. Controlling blood sugar and blood pressure might prevent or delay kidney issues and other complications.
In the early stages of diabetic nephropathy, your treatment might include medicines to manage the following:. Blood sugar. Medicines can help control high blood sugar in people with diabetic nephropathy. They include older diabetes medicines such as insulin. Newer drugs include Metformin Fortamet, Glumetza, others , glucagon-like peptide 1 GLP-1 receptor agonists and SGLT2 inhibitors.
Ask your health care professional if treatments such as SGLT2 inhibitors or GLP-1 receptor agonists might work for you. These treatments can protect the heart and kidneys from damage due to diabetes. If you take these medicines, you'll need regular follow-up testing. The testing is done to see if your kidney disease is stable or getting worse.
During kidney transplant surgery, the donor kidney is placed in the lower abdomen. Blood vessels of the new kidney are attached to blood vessels in the lower part of the abdomen, just above one of the legs.
The new kidney's duct through which urine passes to the bladder, called the ureter, is joined to the bladder. Unless they are causing complications, the other kidneys are left in place. For kidney failure, also called end-stage kidney disease, treatment focuses on either replacing the work of your kidneys or making you more comfortable.
Options include:. Kidney dialysis. This treatment removes waste products and extra fluid from the blood. Hemodialysis filters blood outside the body using a machine that does the work of the kidneys. For hemodialysis, you might need to visit a dialysis center about three times a week.
Or you might have dialysis done at home by a trained caregiver. Each session takes 3 to 5 hours. Peritoneal dialysis uses the inner lining of the abdomen, called the peritoneum, to filter waste.
A cleansing fluid flows through a tube to the peritoneum. This treatment can be done at home or at work. But not everyone can use this method of dialysis. In the future, people with diabetic nephropathy may benefit from treatments being developed using techniques that help the body repair itself, called regenerative medicine.
These techniques may help reverse or slow kidney damage. For example, some researchers think that if a person's diabetes can be cured by a future treatment such as pancreas islet cell transplant or stem cell therapy, the kidneys might work better.
These therapies, as well as new medicines, are still being studied. Explore Mayo Clinic studies testing new treatments, interventions and tests as a means to prevent, detect, treat or manage this condition.
Diet, exercise and self-care are needed to control blood sugar and high blood pressure. Your diabetes care team can help you with the following goals:. Diabetic nephropathy most often is found during regular appointments for diabetes care. If you've been diagnosed with diabetic nephropathy recently, you may want to ask your health care professional the following questions:.
Before any appointment with a member of your diabetes treatment team, ask whether you need to follow any restrictions, such as fasting before taking a test.
Margaret K. YuJephropathy KatonBessie A. Young; Stay energized and hydrated with these fluids Self-Care, Major Depression, and Chronic Kidney Nephropathg in seelf-care Outpatient Diabetic Population. Nephron Clinical Practice 1 December ; : — Depressed patients with diabetes are known to have worse diabetes self-care, but it is not known whether this mediates the association between depression and CKD in this population. Depression status was ascertained using the Patient Health Questionnaire-9 PHQ
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