UMIN-CTR Clinical Trial

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 Kenji Middle name Last name Yabuwaki
Organization	Tohoku Fukushi University
Division name	Department of Rehabilitation, Faculty of Health Sciences
Zip code	989-3201
Address	6-149-1 Kunimigaoka, Aoba-ku, Sendai-shi, Miyagi
TEL	022-728-6038
Email	k-yabuwaki@tfu-mail.tfu.ac.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Yabuwaki
Organization	Tohoku Fukushi University
Division name	Department of Rehabilitation, Faculty of Health Sciences
Zip code	989-3201
Address	6-149-1 Kunimigaoka, Aoba-ku, Sendai-shi, Miyagi
TEL	022-728-6038
Homepage URL
Email	k-yabuwaki@tfu-mail.tfu.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	Japanese Association of Occupational Therapists
Address	Morimitsu-shinko Bldg., 1-5-9 Kotobuki, Taito-ku,Tokyo
Tel	03-5826-7871
Email	kadaikenkyu@jaot.or.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	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	2021 Year 03 Month 14 Day

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