UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036942
Receipt number R000042096
Scientific Title Development of a social activity program using ICT to prevent flail in urban
Date of disclosure of the study information 2021/04/01
Last modified on 2023/12/16 08:51:36

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Basic information

Public title

Development of a social activity program using ICT to prevent flail in urban

Acronym

Development of a social activity program using ICT to prevent flail in urban

Scientific Title

Development of a social activity program using ICT to prevent flail in urban

Scientific Title:Acronym

Development of a social activity program using ICT to prevent flail in urban

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to implement and test the effects of a social activity program for flail prevention among older men living in urban areas using a collective social activity program and an interaction app.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Social flail evaluation items

Key secondary outcomes

Physical fare evaluation items
Psychological flare evaluation items


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

1. Implementation of social activity programs in monthly group activities
2. Use of a smartphone with an interaction app downloaded

Interventions/Control_2

Observation only

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

65 years-old <=

Age-upper limit

99 years-old >

Gender

Male

Key inclusion criteria

1. Older people who don't need assistance in activities of daily living
2. Obtained consent to participate in the study

Key exclusion criteria

None

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Michiyo
Middle name
Last name Hirano

Organization

Hokkaido University

Division name

Faculty of Health Sciences

Zip code

060-0812

Address

N12W5, Kita-ku, Sapporo 060-0812, Japan

TEL

011-706-3377

Email

mihirano@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Michiyo
Middle name
Last name Hirano

Organization

Hokkaido University

Division name

Faculty of Health Sciences

Zip code

060-0812

Address

N12W5, Kita-ku, Sapporo 060-0812, Japan

TEL

011-706-3377

Homepage URL


Email

mihirano@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Ethics Committee

Address

N12W5, Kita-ku, Sapporo 060-0812, Japan

Tel

011-706-3316

Email

shomu@hs.hokudai.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

2021 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1111/opn.12575

Number of participants that the trial has enrolled

11

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

Completed

Date of protocol fixation

2019 Year 06 Month 15 Day

Date of IRB

2019 Year 05 Month 13 Day

Anticipated trial start date

2019 Year 08 Month 20 Day

Last follow-up date

2023 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 06 Month 03 Day

Last modified on

2023 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name