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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name