UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032305
Receipt No. R000036773
Scientific Title Effects of comprehensive environmental support on occupational therapy for community-dwelling older adults: a randomized controlled trial
Date of disclosure of the study information 2018/04/18
Last modified on 2018/04/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of comprehensive environmental support on occupational therapy for community-dwelling older adults: a randomized controlled trial
Acronym Effects of comprehensive environmental support on occupational therapy for community-dwelling older adults: a randomized controlled trial
Scientific Title Effects of comprehensive environmental support on occupational therapy for community-dwelling older adults: a randomized controlled trial
Scientific Title:Acronym Effects of comprehensive environmental support on occupational therapy for community-dwelling older adults: a randomized controlled trial
Region
Japan

Condition
Condition Disuse syndrome
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to identify the effects of comprehensive environmental support on the occupational therapy for community-dwelling older adults through a randomized controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes MOS 36-Item Short-Form Health Survey (SF-36) Japanese version (three months after intervention)
Key secondary outcomes Nishimura's Activity of Daily Living Scale (N-ADL) and Life Satisfaction-100 (LS-100) (three months after intervention)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Participants in the experimental group receive occupational therapy using the Comprehensive Environmental Questionnaire for the Elderly (CEQ) for three months. The CEQ aims to identify environmental factors that affect the QOL among community living adults, and consists of 14 items grouped into three factors (secure environment, interactive environment and family environment). Based on a result of the CEQ, occupational therapists support to improve environmental factors one to four times a week, which collaborated other professions. Before an intervention, we individually educate the usage of the CEQ and comprehensive (i.e. physical, social and institutional) environmental support to the occupational therapists for a day.
Interventions/Control_2 Participants in the control group receive standard occupational therapy in the facility for three months. Occupational therapists support to improve body functions and/or ADLs one to four times a week.
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

Not applicable
Gender Male and Female
Key inclusion criteria Participants newly utilize nursing care and rehabilitation in home care facilities. They are in a stable physical condition and indicate an agreement to participate in the study.
Key exclusion criteria Participants have major communication or cognitive deficits. We will cancel the investigation of participant that could not carry on occupational therapy in the facility.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Yabuwaki
Organization Kibi International University
Division name Department of Occupational Therapy, School of Health Science and Social Welfare
Zip code
Address 8 Igamachi, Takahashi-shi, Okayama
TEL 0866-22-9404
Email yabu@kiui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Yabuwaki
Organization Kibi International University
Division name Department of Occupational Therapy, School of Health Science and Social Welfare
Zip code
Address 8 Igamachi, Takahashi-shi, Okayama
TEL 0866-22-9404
Homepage URL
Email yabu@kiui.ac.jp

Sponsor
Institute Kibi International University
Institute
Department

Funding Source
Organization Japanese Association of Occupational Therapists
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 牧田病院デイケアセンター(北海道),デイサービスだいち(北海道),介護老人保健施設エバーグリーン・ツルガヤ(宮城県),寺岡クリニック通所リハビリテーション(宮城県),介護老人保健施設回生の里(千葉県),ケアホームしあわせデイサービスセンター(静岡県),リハステーション守山デイサービス(滋賀県),介護老人保健施設あけぼの(高知県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 18 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 Completed
Date of protocol fixation
2011 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 08 Day
Last follow-up date
2012 Year 06 Month 27 Day
Date of closure to data entry
2012 Year 10 Month 17 Day
Date trial data considered complete
2012 Year 10 Month 31 Day
Date analysis concluded
2013 Year 01 Month 08 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 18 Day
Last modified on
2018 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036773

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.