UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031695 |
|---|---|
| Receipt number | R000036199 |
| Scientific Title | Examining the effects of home-visit occupational therapy using the Management Tool for Daily Life Performance on the social functioning of people with mental disabilities |
| Date of disclosure of the study information | 2018/03/13 |
| Last modified on | 2019/08/05 11:33:52 |
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Basic information
Public title
Examining the effects of home-visit occupational therapy using the Management Tool for Daily Life Performance on the social functioning of people with mental disabilities
Acronym
Examining the effects of home-visit OT using MTDLP on the social functioning of people with mental disabilities
Scientific Title
Examining the effects of home-visit occupational therapy using the Management Tool for Daily Life Performance on the social functioning of people with mental disabilities
Scientific Title:Acronym
Examining the effects of home-visit OT using MTDLP on the social functioning of people with mental disabilities
Region
| Japan |
Condition
Condition
Mental illness
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of home-visit occupational therapy (OT) using the Management Tool for Daily Life Performance (MTDLP) on the social functioning and quality of life (QOL) of people with mental disabilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Social Functioning Scale
Japanese Version
Key secondary outcomes
WHO QOL26
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group: Home-visit OT using MTDLP
Occupational therapists will conduct home-visit OT once a week, for 30 minutes to 1 hour each, for a duration of 4 months.
MTDLP is tool for assessment, planning, and management developed by the Japanese Association of Occupational Therapists. By using MTDLP, occupational therapists support patients in enabling them to perform what they hope to or cannot, despite wanting to do in their lives.
The intervention of home-visit OT using MTDLP for lifestyle improvement is designed to enable patients to perform their daily activities as they desire at the actual place where they live.
Interventions/Control_2
Control group: Usual Home-visit OT
Occupational therapists will conduct home-visit OT once a week, for 30 minutes to 1 hour each, for 4 months.
This intervention that does not use MTDLP has contents decided by the occupational therapists with due consideration of patients'needs.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. People with mental disabilities aged 18 to 65 years
2. A person who was prescribed psychiatric home-visit nursing by the attending doctor and is already receiving or planning to undergo it
3. A person deemed appropriate for this study by the director of the collaborative research institution
4. A person allowed to participate this study by the attending doctor
5. A person who has provided written consent for participating in this research; in the case of minors, those who have provided written consent and have obtained it from their parents
Key exclusion criteria
1. A person who has been diagnosed with severe mental retardation, dementia, or substance use-related disorder
2. A person who has declined to participate in this research
3. A person who is evaluated to be unable to give sufficient consent by the attending doctor or the director of the collaborative research institution
4. A person whose psychiatric symptoms was predicted to worsen because of participating in this research by the director of the collaborative research institution or attending doctor
5. A person who is unable to complete pre-assessment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Kobe University Graduate School
Division name
Health Sciences
Zip code
6540142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe
TEL
078-796-4576
hashimo@kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Mashimo |
Organization
Kobe University Graduate School
Division name
Doctoral Course of Health Sciences
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe
TEL
090-1140-5493
Homepage URL
muuhina0915@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
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
Visiting Nurse Station Cocoroccle
HEALTHCARE CORPORATIONS KOUNOIKE-KAI AKITSUKOUNOIKE HOSPITAL
Ujioubaku-Hospital
Kibouya home-visit nursing station
Nagaoka Health Care Center"Nagaoka Hospital"
Hyogo Mental Health Center
Visiting nursing station Arimakougen
Home Visiting Station Inaho
Shukokai home-visit nursing station "Wing"
Home Visiting Station Clover
Home Nursing Station'KEYAKI'
Home Nursing Station Satuki-kan(Satsuki House)
Visiting Nursing Station Hiraku
Visiting Nursing Station Musubu
Psychiatric home-visit nursing care uninet machikado
Warai Home Nursing Station
Houmonkango station ""fureai"" Hannan hospital
Muromachi home-visit nursing station
Visiting nursing station Relife inokuchi
Senogawa Medical Corporation Visiting nursing station Visite
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences
Address
7-10-2, Tomogaoka, Suma-ku, Kobe ,Hyougo
Tel
078-792-5555
syomu2@ams.kobe-u.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
| 2018 | Year | 03 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036199
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
