UMIN-CTR Clinical Trial
| 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 (Ver. 4) |
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| Basic information | ||
| Public title | Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
(Pilot Study) |
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| Acronym | Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials | |
| Scientific Title | Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials
(Pilot Study) |
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| Scientific Title:Acronym | Educational Approach System in Hemodialysis Patients: Randomized Controlled Trials | |
| Region |
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| Condition | |||
| Condition | Chronic hemodialysis in outpatients | ||
| Classification by specialty |
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| 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 |
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| Interventions/Control_1 | Educational approach
Usually management Intervention period is 6 months |
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| 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 |
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| Age-upper limit |
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| 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 |
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| Key exclusion criteria | A hospitalized patient,
Patients who have moved out of the research collaboration facility |
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| Target sample size | 80 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 | ||||||
| yamana-umin@umin.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| 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 | |||||||
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed |
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| 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. |
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| 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. |
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| Adverse events | No adverse events were observed. |
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| Outcome measures | Intervention through an educational approach system demonstrated effect on laboratory values of serum phosphorus and QOL. |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Terminated | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| 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 |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043952 |
