UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044276
Receipt number R000050573
Scientific Title Questionnaire survey to investigate muscle mass assessment
Date of disclosure of the study information 2021/05/21
Last modified on 2022/11/20 10:18:23

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Basic information

Public title

Questionnaire survey to investigate muscle mass assessment

Acronym

Questionnaire survey to investigate muscle mass assessment

Scientific Title

Questionnaire survey to investigate muscle mass assessment

Scientific Title:Acronym

Questionnaire survey to investigate muscle mass assessment

Region

Japan


Condition

Condition

Medicine and surgery in general

Classification by specialty

Medicine in general Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate muscle mass assessment in practice and to improve proper muscle mass assessment

Basic objectives2

Others

Basic objectives -Others

To clear educational opportunity in muscle mass assessment

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle mass assessment in practice

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Doctor, nurse, physical therapist, occupational therapist, nutritionist

Key exclusion criteria

Non-medical worker

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Nobuto
Middle name
Last name Nakanishi

Organization

Kobe university

Division name

Department of Disaster and Emergency Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki, Chuo-ward, Kobe

TEL

078-382-6521

Email

nobuto_nakanishi@yahoo.co.jp


Public contact

Name of contact person

1st name Nobuto
Middle name
Last name Nakanishi

Organization

Kobe university

Division name

Department of Disaster and Emergency Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki, Chuo-ward, Kobe

TEL

078-382-6521

Homepage URL


Email

nobuto_nakanishi@yahoo.co.jp


Sponsor or person

Institute

Kobe university

Institute

Department

Personal name



Funding Source

Organization

Kobe University

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

Ethical committee in Kobe university

Address

Kobe University, 7-5-2 Kusunoki, Chuo-ward, Kobe

Tel

0783826669

Email

kansatsu@med.kobe-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

神戸大学病院


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 21 Day


Related information

URL releasing protocol

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0276855

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/36327311/

Number of participants that the trial has enrolled

1058

Results

In total, 93% of the participants were familiar with general muscle mass assessment, and 64% had conducted it. Ultrasound-based muscle mass assessment was performed by 21% of the participants. Necessity and interest scored 7 (6-8) and 8 (7-10), respectively for ultrasound-based muscle mass assessment. The barriers to its implementation included lack of relevant education (84%), limited staff (61%), and absence of fixed protocol (61%).

Results date posted

2022 Year 11 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Of the 1,058 responders, 1,026 participants, comprising 282 physicians, 489 physical therapists, 84 occupational therapists, 120 nurses, and 51 dieticians, were included in the analysis.

Participant flow

Answering in the online survey

Adverse events

None

Outcome measures

a web-based cross-sectional survey was conducted on healthcare providers in Japan, which comprised four parts: 1) participant characteristics; 2) general muscle mass assessment; 3) ultrasound-based muscle mass assessment; and 4) the necessity of, interest in, and barriers to its implementation.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 05 Month 18 Day

Date of IRB

2021 Year 06 Month 20 Day

Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2021 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Questionnaire survey by using google form


Management information

Registered date

2021 Year 05 Month 21 Day

Last modified on

2022 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name