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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025792
Receipt No. R000028795
Scientific Title A Multicenter, randomized, parallel-group study assessing efficacy of actual support of renal replacement therapy modality selection program(CKD-SMD app) and home blood pressure measurement system in patients with chronic kidney disease(CKD)
Date of disclosure of the study information 2017/01/22
Last modified on 2019/07/27

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Basic information
Public title A Multicenter, randomized,
parallel-group study assessing efficacy of actual support of renal replacement therapy modality selection program(CKD-SMD app) and
home blood pressure measurement system in patients with chronic kidney disease(CKD)
Acronym A Multicenter, randomized,
parallel-group study assessing efficacy of actual support of renal replacement therapy modality selection program(CKD-SMD app) and
home blood pressure measurement system in chronic kidney disease(CKD)
Scientific Title A Multicenter, randomized,
parallel-group study assessing efficacy of actual support of renal replacement therapy modality selection program(CKD-SMD app) and
home blood pressure measurement system in patients with chronic kidney disease(CKD)
Scientific Title:Acronym A Multicenter, randomized,
parallel-group study assessing efficacy of actual support of renal replacement therapy modality selection program(CKD-SMD app) and
home blood pressure measurement system in chronic kidney disease(CKD)
Region
Japan

Condition
Condition Patients with chronic kidney disease(CKD)
Classification by specialty
Nephrology Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to develop a support decision making (SDM) application for patients with chronic kidney disease (CKD), to prevent their future disease progression and support decision making regarding renal replacement therapy (RRT) and uncover the effect of SDM application for patients with CKD, to prevent their future disease progression and support decision making RRT .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes *The data of blood pressure:(Changes in the data of home blood pressure)
Key secondary outcomes *Renal function:Blood sampling data (Hb,Ht,RBC.eGFR, S-cre, BUN), Spot urine measured on one occasion (proteinuria or albuminuria) s
*Self efficacy,Kidney disease burden,Knowledge level of self management in CKD,Kind of decision for renal replacement therapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Behavior,custom Other
Interventions/Control_1 Intervention: Subjects receive usual care from the attending physician and we lend them the tablet equipped with CKD-SMD app and they are gotten browse by self during 8 weeks.(From the time of the start of the survey to next time outpatient visits). Its content is composed "Lets study CKD" and "What is RRT?"On the other hand, the advanced levels included 4 menus: "Learn and consent CKD" "The reality of hemodialysis" "The reality of peritoneal dialysis" "The reality of peritoneal dialysis" and "The reality of kidney transplantation".In addition, we lend procedure of blood pressure measurement method and sphygmomanometer with communication function for subjects,they use it to get the data of blood pressure measurement for 8 weeks. After that we will recover the machines from them. And they answer the questionnaire three times(baseline and next time outpatient visits and after 6 months finished the examination).
Interventions/Control_2 Control : Subjects receive usual care from the attending physician.In addition, we lend procedure of blood pressure measurement method andsphygmomanometer with communication function for subjects,they use it to get the data of blood pressure measurement for 8 weeks.After that we will recover the machine from them. And they answer the questionnaire three times baseline and next time outpatient visits and after 6 months finished the examination).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria are patients in the kidney internal medicine hospital and to be assure by doctor.
Patients before renal replacement therapy selection and eGFR<60.
To participate in this study received sufficient information, obtained the written consent by the free will of the individual.
Key exclusion criteria Investigator or investigator be inappropriate as determined.
After renal transplantation.
they are likely to introduce renal replacement therapy within one month.
Minor
Target sample size 68

Research contact person
Name of lead principal investigator
1st name Shiho
Middle name
Last name Shiho Kosaka
Organization Department of Sophia University
Division name Nursing
Zip code 1618550
Address 4-16-11,shimo-otiai shinjyukuku, Tokyo
TEL 03-3950-6159
Email skosaka-tky@umin.ac.jp

Public contact
Name of contact person
1st name Shiho
Middle name
Last name Kosaka
Organization Department of Sophia University
Division name Nursing
Zip code 1618550
Address 4-16-11,shimo-otiai shinjyukuku, Tokyo
TEL 03-3950-6159
Homepage URL
Email skosaka-tky@umin.ac.jp

Sponsor
Institute Department of Sophia University
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Toranomon Hospital Kajigaya, Department of Internal Medicine, Hospital Kidney Center.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sophia University IRB
Address 4 Yonbancho Chiyoda Tokyo
Tel 03-3238-4050
Email farie3@sophia.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 虎の門病院分院 腎センター(神奈川)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 22 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_regist.cgi?recptno=R000028795&flwp_key=9005eSwtTcNA7
Publication of results Partially published

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled 54
Results
 All participants baseline data were the mean (SD) age, eGFR, and HBPM (morning and evening) of participants were 70.7(11.0) years, 37.0ml/min per 1.73 m2, and 133.7/78.3 and 130.5/76.0mmHg, respectively. No significant differences between groups were observed at baseline. In the female intervention group, the morning systolic blood pressure (SBP) difference significantly decreased, -7.7 vs. -2.6 mmHg (p<0.05).
Results date posted
2019 Year 07 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
 This study was a randomized, controlled trial involving 54 patients with stage 3, 4, or 5 non-dialysis CKD
Participant flow
The intervention group was provided with a tablet equipped with the CKD-SDM app. An automated sphygmomanometer for home blood pressure monitoring (HBPM) was used in both groups for 8 weeks.
Adverse events
nothing
Outcome measures
change in HBPM,changes in renal functions and self-management knowledge level 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 02 Month 27 Day
Date of IRB
2017 Year 02 Month 27 Day
Anticipated trial start date
2017 Year 03 Month 07 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 22 Day
Last modified on
2019 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028795

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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