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UMIN-CTR Clinical Trial |
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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 | 2019/08/05 |
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 |
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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 |
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Scientific Title:Acronym | Examining the effects of home-visit OT using MTDLP on the social functioning of people with mental disabilities | |
Region |
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Condition | |||
Condition | Mental illness | ||
Classification by specialty |
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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.
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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 |
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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. |
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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. |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Baseline Characteristics | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Anticipated trial start date |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |