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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000038568
Receipt No. R000043952
Scientific Title Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials (Pilot Study)
Date of disclosure of the study information 2019/11/13
Last modified on 2019/11/13

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Basic information
Public title Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
(Pilot Study)
Acronym Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
Scientific Title Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
(Pilot Study)
Scientific Title:Acronym Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
Region
Japan

Condition
Condition Chronic hemodialysis in outpatients
Classification by specialty
Nephrology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of an educational approach system using Two-Dimensional Mapping (2DM)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes QOL
Key secondary outcomes percentage weight gain
urea nitrogen
creatinine
serum potassium level
serum phosphorus level
serum calcium level
hematocrit
hemoglobin

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Educational approach
Usually management
Intervention period is 6 months
Interventions/Control_2 Usually management
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) receiving hemodialysis on an outpatient basis
2) hemodialysis experience of at least 4 months
3) systemically stable physical condition
4) percentage increase in body weight of at least 5% measured every 2 days
5) serum potassium of at least 5.1 mEq/l with regular tests
6) reliably functioning vascularaccess
7) mentally and emotionally stable
8) ability to complete the questionnaire by himself/herself
For 4) and 5), patients who satisfied one of the criteria and met the criteria at least twice during the 3 months
Key exclusion criteria A hospitalized patient,
Patients who have moved out of the research collaboration facility
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Eiko
Middle name
Last name Yamana
Organization Former Fukuoka Prefectural University
Division name School of Nursing
Zip code 825-8585
Address 4395 Ita,Tagawa City,Fukuoka,Japan
TEL +81-947-42-2118
Email yamana-umin@umin.ac.jp

Public contact
Name of contact person
1st name Eiko
Middle name
Last name Yamana
Organization Former Fukuoka Prefectural University
Division name School of Nursing
Zip code 825-8585
Address 4395 Ita,Tagawa City,Fukuoka,Japan
TEL +81-947-42-2118
Homepage URL
Email yamana-umin@umin.ac.jp

Sponsor
Institute Fukuoka Prefectural University
Institute
Department

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 Fukuoka Prefectural University Research Ethics Committee
Address 4395 Ita,Tagawa City,Fukuoka,Japan
Tel +81-947-42-2118
Email kyomu5@fukuoka-pu.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
2019 Year 11 Month 13 Day

Related information
URL releasing protocol NA
Publication of results Partially published

Result
URL related to results and publications NA
Number of participants that the trial has enrolled 30
Results
QOL had a significantly greater increase in the intervention group compared to the control group. Modulation in serum phosphorus levels was significantly different between the two groups and was significantly lower in the intervention group compared to the control group. 
Results date posted
2019 Year 11 Month 13 Day
Results Delayed
Delay expected
Results Delay Reason It takes time to publish the results.
Date of the first journal publication of results
Baseline Characteristics
Baseline attributes of the participants showed no difference between the two groups. 
Participant flow
Two participants in the intervention group (n=15) were lost to follow-up due to relocation and four participants in the control group (n=15) were lost to follow-up due to hospitalization (n=3) and relocation (n=1).  This resulted in 13 patients in the intervention group and 10 patients in the control group for analysis. 
Adverse events
No adverse events were observed.
Outcome measures
Intervention through an educational approach system demonstrated effect on laboratory values of serum phosphorus and QOL.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2009 Year 11 Month 25 Day
Date of IRB
2009 Year 11 Month 25 Day
Anticipated trial start date
2010 Year 05 Month 13 Day
Last follow-up date
2011 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The title of ethics review and the title of registration are different.

Management information
Registered date
2019 Year 11 Month 13 Day
Last modified on
2019 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043952

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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