UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051706 |
|---|---|
| Receipt number | R000059001 |
| Scientific Title | Impact of online medical assistance using a smartphone for primary physicians and patients with chronic kidney disease on clinical practice and patients' outcome. |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/25 06:31:13 |
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Basic information
Public title
Impact of online medical assistance using a smartphone for primary physicians and patients with chronic kidney disease on clinical practice and patients' outcome.
Acronym
Effectiveness of smartphone based online medical assistance in chronic kidney disease
Scientific Title
Impact of online medical assistance using a smartphone for primary physicians and patients with chronic kidney disease on clinical practice and patients' outcome.
Scientific Title:Acronym
Effectiveness of smartphone based online medical assistance in chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the non-inferiority of online medical assistance for primary physicians and patients (Doctor to patients with doctor; D to P with D) compared to conventional face-to-face care by nephrologists, not only in improving family doctor and patient satisfaction, but also in preventing CKD progression and improving prognosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Prognosis of renal function during the 2-year observation period
2) Patient and institution characteristics in face-to-face care and online medical assistance care
Key secondary outcomes
1) Assessment of institutional and patient satisfaction using questionnaires
2) Expanded MACE (non-fatal myocardial infarction and stroke, cardiovascular death, heart failure for hospitalization, unstable angina, percutaneous coronary intervention)during the 2-year observation period
3) Number of online medical assistance, number of visits to family doctors, and number of visits to nephrologists during the observation period
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with CKD stage G3b-4 (eGFR 15-<45ml/min/1.73m2) aged 18 years or older who have given written consent to participate in this study and to receive online medical assistance, and family doctors that have agreed to participate in this study
Key exclusion criteria
1) Patients with suspected rapid progressive glomerulonephritis syndrome
2) Patients with suspected nephrotic syndrome
3) Heart failure (NYHA 3and 4)
4) Poorly controlled hypertension (systolic blood pressure 180mmHg or more, diastolic blood pressure 110mmHg or more)
5) Patients whose participation in this study is deemed inappropriate by the physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Terumasa |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka General Medical Center
Division name
Department of Kidney Disease and Hypertension
Zip code
558-8558
Address
3-1-56 Bandaihigashi Sumiyoshi-ku, Osaka
TEL
06-6692-1201
t-hayashi@abelia.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Terumasa |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka General Medical Center
Division name
Department of Kidney Disease and Hypertension
Zip code
558-8558
Address
3-1-56 Bandaihigashi Sumiyoshi-ku, Osaka
TEL
0666921201
Homepage URL
t-hayashi@abelia.ocn.ne.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Terumasa Hayashi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Medical Ethics Review Board, Osaka General Medical Center
Address
3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka
Tel
06-6692-1201
kenkyu@gh.opho.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 | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study to examine the non-inferiority of the online medical assistance group to the in-person group for the primary endpoint (eGFR 50% reduction, eGFR <15 ml/min/1,73 m2, and initiation of renal replacement therapy) during a 2-year observation period
Management information
Registered date
| 2023 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059001
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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