UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025792 |
|---|---|
| Receipt number | 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 15:14:35 |
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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
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
skosaka-tky@umin.ac.jp
Sponsor or person
Institute
Department of Sophia University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028795
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| Registered date | File name |
| Research case data | |
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