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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031695
Receipt No. 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 2018/11/17

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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
Middle name
Last name Takeshi Hashimoto
Organization Kobe University Graduate School
Division name Health Sciences
Zip code
Address 7-10-2, Tomogaoka, Suma-ku, Kobe
TEL 078-796-4576
Email hashimo@kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Izumi Mashimo
Organization Kobe University Graduate School
Division name Doctoral Course of Health Sciences
Zip code
Address 7-10-2, Tomogaoka, Suma-ku, Kobe
TEL 090-1140-5493
Homepage URL
Email muuhina0915@gmail.com

Sponsor
Institute Kobe University Graduate School of Health Sciences
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 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'

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
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
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
Anticipated trial start date
2018 Year 03 Month 13 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
2018 Year 03 Month 12 Day
Last modified on
2018 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036199

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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