Unique ID issued by UMIN | UMIN000038568 |
---|---|
Receipt number | 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 23:19:46 |
Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
(Pilot Study)
Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
(Pilot Study)
Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
Japan |
Chronic hemodialysis in outpatients
Nephrology | Nursing |
Others
NO
To investigate the usefulness of an educational approach system using Two-Dimensional Mapping (2DM)
Efficacy
Not applicable
QOL
percentage weight gain
urea nitrogen
creatinine
serum potassium level
serum phosphorus level
serum calcium level
hematocrit
hemoglobin
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Maneuver |
Educational approach
Usually management
Intervention period is 6 months
Usually management
Not applicable |
Not applicable |
Male and Female
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
A hospitalized patient,
Patients who have moved out of the research collaboration facility
80
1st name | Eiko |
Middle name | |
Last name | Yamana |
Former Fukuoka Prefectural University
School of Nursing
825-8585
4395 Ita,Tagawa City,Fukuoka,Japan
+81-947-42-2118
yamana-umin@umin.ac.jp
1st name | Eiko |
Middle name | |
Last name | Yamana |
Former Fukuoka Prefectural University
School of Nursing
825-8585
4395 Ita,Tagawa City,Fukuoka,Japan
+81-947-42-2118
yamana-umin@umin.ac.jp
Fukuoka Prefectural University
None
Self funding
Fukuoka Prefectural University Research Ethics Committee
4395 Ita,Tagawa City,Fukuoka,Japan
+81-947-42-2118
kyomu5@fukuoka-pu.ac.jp
NO
2019 | Year | 11 | Month | 13 | Day |
NA
Partially published
NA
30
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.
2019 | Year | 11 | Month | 13 | Day |
Delay expected |
It takes time to publish the results.
Baseline attributes of the participants showed no difference between the two groups.
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.
No adverse events were observed.
Intervention through an educational approach system demonstrated effect on laboratory values of serum phosphorus and QOL.
Terminated
2009 | Year | 11 | Month | 25 | Day |
2009 | Year | 11 | Month | 25 | Day |
2010 | Year | 05 | Month | 13 | Day |
2011 | Year | 12 | Month | 31 | Day |
The title of ethics review and the title of registration are different.
2019 | Year | 11 | Month | 13 | Day |
2019 | Year | 11 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043952
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Registered date | File name |
Research case data | |
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Registered date | File name |