UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022407 |
|---|---|
| Receipt number | R000025254 |
| Scientific Title | Research on the effectiveness of the modified version of collaborative partnership model in the self-management acquisition of systemic lupus erythematosus patients |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2017/11/27 09:07:56 |
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Basic information
Public title
Research on the effectiveness of the modified version of collaborative partnership model in the self-management acquisition of systemic lupus erythematosus patients
Acronym
Research on the effectiveness of the modified version of collaborative partnership model in the self-management acquisition of systemic lupus erythematosus patients
Scientific Title
Research on the effectiveness of the modified version of collaborative partnership model in the self-management acquisition of systemic lupus erythematosus patients
Scientific Title:Acronym
Research on the effectiveness of the modified version of collaborative partnership model in the self-management acquisition of systemic lupus erythematosus patients
Region
| Japan |
Condition
Condition
Systemic Lupus Erythematosus
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a nursing intervention model for SLE patients to help the self-management acquisition for to engage in the social life seems to the people, it is to verify the effectiveness of the modified version of collaborative partnership model.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difficulties in the SLE patient care
Key secondary outcomes
Subjective QOL of incurable patients
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention period; about 2 months.
Intervention model; modified version of collaborative partnership model.
Lead to the acquisition of the self-management of SLE patients using a model; intervention content.
Analytical methods;and conducted interviews before and after the intervention,and analyzed by qualitative inductive method.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
SLE patients with comprehension, of decision-making capacity
Key exclusion criteria
Patient understanding, there is no decision-making ability SLE
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KUMIKO UZAWA |
Organization
Juntendo University Faculty of Health Care and Nursing
Division name
Adult Health Nursing
Zip code
Address
2-5-1,takasu,urayasu city,Chiba
TEL
047-350-4046
kkuwae@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KUMIKO UZAWA |
Organization
Juntendo University Faculty of Health Care and Nursing
Division name
Adult Health Nursing
Zip code
Address
2-5-1,takasu,urayasu city,Chiba
TEL
047-350-4046
Homepage URL
kkuwae@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025254
