UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027409
Receipt number R000031410
Scientific Title The Collaborative Client-Centered Approach is effective for Instrumental Activities of Daily Living occupational therapy in a Japanese setting.
Date of disclosure of the study information 2017/05/19
Last modified on 2017/05/19 15:41:11

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Basic information

Public title

The Collaborative Client-Centered Approach is effective for Instrumental Activities of Daily Living occupational therapy in a Japanese setting.

Acronym

The Collaborative Approach is effective for Instrumental Activities of Daily Living.

Scientific Title

The Collaborative Client-Centered Approach is effective for Instrumental Activities of Daily Living occupational therapy in a Japanese setting.

Scientific Title:Acronym

The Collaborative Approach is effective for Instrumental Activities of Daily Living.

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to compare the effectiveness of collaborative, client-led, and therapist-led approaches.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Assessment of Motor and Process Skills(AMPS)(after three intervention sessions)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Other

Interventions/Control_1

The collaborative approach comprised weekly one-hour sessions and ran for three weeks.

Interventions/Control_2

The client-led approach comprised weekly one-hour sessions and ran for three weeks.

Interventions/Control_3

The therapist-led approach comprised weekly one-hour sessions and ran for three weeks.

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

40 years-old >

Gender

Male and Female

Key inclusion criteria

All participants were recruited consistent with the following inclusion criteria: healthy adults with no IADL disability history; familiar with >10 IADLs on a list created for this study; no prior expertise, knowledge, or skills related to the occupational therapy intervention.

Key exclusion criteria

Participants who meet key inclusion criteria

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaneno Tatsuya

Organization

Mejiro University

Division name

Department of Occupational Therapy

Zip code


Address

339-8501 320 Ukiya, iwatukiku, Saitama city, Saitama-ken Japan

TEL

048-797-2152

Email

kaneno@mejiro.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaneno Tatsuya

Organization

Mejiro University

Division name

Department of Occupational Therapy

Zip code


Address

339-8501 320 Ukiya, iwatukiku, Saitama city, Saitama-ken Japan

TEL

048-797-2152

Homepage URL

https://www.mejiro.ac.jp/univ/course/health/ot/

Email

kaneno@mejiro.ac.jp


Sponsor or person

Institute

Mejiro University

Institute

Department

Personal name



Funding Source

Organization

Self-funding

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


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

2017 Year 05 Month 19 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

Completed

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 01 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

2017 Year 05 Month 19 Day

Last modified on

2017 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031410


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name