UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050427 |
|---|---|
| Receipt number | R000057428 |
| Scientific Title | Multicenter Interventional Trial of a Mobile Phone Application for Self-Management in Patients with Chronic Kidney Disease |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2025/02/26 12:52:32 |
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Basic information
Public title
Multicenter Interventional Trial of a Mobile Phone Application for Self-Management in Patients with Chronic Kidney Disease
Acronym
Multicenter Interventional Trial of a Mobile Phone Application for Self-Management in Patients with Chronic Kidney Disease
Scientific Title
Multicenter Interventional Trial of a Mobile Phone Application for Self-Management in Patients with Chronic Kidney Disease
Scientific Title:Acronym
Multicenter Interventional Trial of a Mobile Phone Application for Self-Management in Patients with Chronic Kidney Disease
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether an intervention using an ambulatory app for patients with chronic kidney disease can improve self-management of medications and other medical care by providing regular self-management information from healthcare providers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of medication compliance after 24 weeks of app intervention
Key secondary outcomes
(1) Rate of blood pressure measurement: The ratio of the number of times the blood pressure was measured (twice a day in the morning and at night).
(2) Rate of weight measurement: Ratio of the number of days weight was measured.
(3) Blood pressure variability: the difference between the blood pressure at the beginning of the observation period (baseline) and the blood pressure at the end of the observation period and the intervention period (systolic and diastolic).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
App-based information delivery
Interventions/Control_2
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
(1) Patients 20 years of age or older at the time of consent.
(2) Patients with CKD stage G2 to G4
(3) Patients receiving antihypertensive medication for at least 4 weeks prior to enrollment
(4) Outpatients
(5) Patients who have given written consent to participate in this study.
Key exclusion criteria
(1) Patients with rapidly progressive glomerulonephritis
(2) Patients with polycystic kidney disease
(3) Patients who have undergone kidney transplantation
(4) Patients deemed inappropriate by the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Nakagawa |
Organization
Asahikawa Medical University
Division name
Division of Cardiology, Nephrology, Pulmonology and Neurology, Department of Internal Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2442
naka-nao@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Nakagawa |
Organization
Asahikawa Medical University
Division name
Division of Cardiology, Nephrology, Pulmonology and Neurology, Department of Internal Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2442
Homepage URL
naka-nao@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido, Japan
Tel
0166-68-2442
naka-nao@asahikawa-med.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
119
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057428
