UMIN-CTR Clinical Trial

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
Email	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
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' 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
Email	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
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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