UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041730
Receipt number R000047631
Scientific Title Serial analysis for anxiety about steroid therapy
Date of disclosure of the study information 2020/09/10
Last modified on 2020/09/08 16:47:40

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Basic information

Public title

Serial analysis for anxiety about steroid therapy

Acronym

Analysis for anxiety about steroid therapy

Scientific Title

Serial analysis for anxiety about steroid therapy

Scientific Title:Acronym

Analysis for anxiety about steroid therapy

Region

Japan


Condition

Condition

Autoimmune disease

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the serial change of anxiety about steroid therapy in patients with autoimmune diseases.

Basic objectives2

Others

Basic objectives -Others

To identify the related factors associated with anxiety about steroid therapy.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Questionnaire for anxiety about steroid therapy, STAI, SDD, SF36

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who treated with steroid therapy(more than prednisolone 20mg/day) for auttoimune diaeses.
2)Patients who are older than 20 years old.
3)Any gender

Key exclusion criteria

Patients who cannot answer the question.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Kubo

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Medicine and Clinical Science

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

TEL

0836-22-2248

Email

mkubo@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Nawata

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Medicine and Clinical Science

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

TEL

0836-22-2248

Homepage URL


Email

tnawata@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University Hospital

Institute

Department

Personal name



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

Yamaguchi University Hospital

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

Tel

0836-22-2428

Email

me223@yamaguchi-u.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

2020 Year 09 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Enrolling by invitation

Date of protocol fixation

2020 Year 08 Month 03 Day

Date of IRB

2020 Year 08 Month 26 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients treated with steroid therapy often show anxiety about steroid therapy. In the current study, serial change of anxiety about steroid therapy is investigated.


Management information

Registered date

2020 Year 09 Month 08 Day

Last modified on

2020 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047631


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name