UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045882 |
|---|---|
| Receipt number | R000052314 |
| Scientific Title | An open-label comparative study to evaluate the effectiveness of video education during outpatient waiting time in chronic kidney disease |
| Date of disclosure of the study information | 2021/10/28 |
| Last modified on | 2024/10/28 15:05:35 |
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Basic information
Public title
An open-label comparative study to evaluate the effectiveness of video education during outpatient waiting time in chronic kidney disease
Acronym
Study on education of chronic kidney disease in outpatient waiting time
Scientific Title
An open-label comparative study to evaluate the effectiveness of video education during outpatient waiting time in chronic kidney disease
Scientific Title:Acronym
Study on education of chronic kidney disease in outpatient waiting time
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether the use of pamphlets and videos in an outpatient setting can be an effective educational intervention for CKD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Kidney Disease Knowledge Survey, translated and modified into Japanese, will be used to assess before and after the educational intervention. The evaluation will be conducted immediately after the educational intervention.
Key secondary outcomes
Perceived kidney knowledge survey, Self-Care behaviors, translated and modified from Japanese. Blood pressure, weight, blood tests (Cre, eGFR), urine tests (Cre, UP, Na and items to be calculated from them). Measured before and after the educational intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
During the outpatient waiting time, take 15 minutes to watch a video on kidney disease education. After completing the second questionnaire, participants will be given a pamphlet on kidney disease education to take home.
Interventions/Control_2
During the outpatient waiting time, take 15 minutes to watch a pamphlet on kidney disease education. After completing the second questionnaire, participants will be given the pamphlet to take home.
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 Inpatient or outpatient: Outpatient
2 CKD stage 3 to 5
3 First time to see a nephrologist
4 Patients whose next outpatient visit will be within 3 months
5 Patients who are able to freely and voluntarily give written consent for participation
Key exclusion criteria
1 Patients who cannot give consent
2 Patients on dialysis and kidney transplant patients
3 Patients who are judged by a principal investigator or sub-investigator to be unsuitable as subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Aizawa |
Organization
Chiba University Hospital
Division name
Nephrology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture, JAPAN
TEL
043-222-7171
m_aizw@chiba-u.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Kimura |
Organization
Chiba University Hospital
Division name
Nephrology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture, JAPAN
TEL
043-222-7171
Homepage URL
maikoco1005@gmail.com
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture, JAPAN
Tel
043-222-7171
inohana-rinri@chiba-u.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
| 2021 | Year | 10 | Month | 28 | 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
50
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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 29 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052314
