UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032305 |
|---|---|
| Receipt number | 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 | 2021/03/14 14:39:29 |
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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
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
k-yabuwaki@tfu-mail.tfu.ac.jp
Sponsor or person
Institute
Kibi International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036773
