UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035795 |
|---|---|
| Receipt number | R000040777 |
| Scientific Title | The effect of consultation focusing on nursing care by occupational therapist |
| Date of disclosure of the study information | 2019/02/07 |
| Last modified on | 2019/02/07 08:57:52 |
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Basic information
Public title
The effect of consultation focusing on nursing care by occupational therapist
Acronym
Effect of Collaborative Goal-Setting with Teachers
Scientific Title
The effect of consultation focusing on nursing care by occupational therapist
Scientific Title:Acronym
Effect of Collaborative Goal-Setting with Teachers
Region
| Japan |
Condition
Condition
Adult and child
Classification by specialty
| Rehabilitation medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the feasibility and effect of an indirect intervention which includes teacher consultation a visiting SBOT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Canadian Occupational Performance Measure (COPM),
Key secondary outcomes
Goal Attainment Scaling (GAS), Strengths and Difficulties Questionnaire (SDQ)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Evaluation and goal-setting: The OTR observes child's school life for an hour based on the SDQ and pre-document. The OTR and teacher discuss the individual- and occupational-based goal by using ADOC-S. The OTR respects the teacher's autonomy and educational policy. In selected goals, teacher rates the performance score and satisfaction using COPM-card.
Planning: The OTR and teacher discuss goals and the intervention plan. OTR encourages the teacher to share opinion and provides suggestions, leading the teacher to consider the intervention plan. The OTR and teacher rate the GAS from -2 to +2. The intervention is planned and provided by teacher.
Follow-up: The OTR reviewed the intervention progress with the teacher using GAS [The GAS was not used to assess outcomes].
Interventions/Control_2
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
| 3 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children in their classroom who: (1) had no diagnosed developmental disorders; (2) were not currently receiving services; but (3) where the teacher recognized developmental delays and the need for special education; and (4) at least one indicated "high need" subcategory of the Strengths and Difficulties Questionnaire (SDQ).
Key exclusion criteria
Non
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sayaka Yamaguchi |
Organization
Nonprofit organization Hablis,
Division name
Hablis
Zip code
Address
1-168-1, Uchihara, Ohgaki-city, Gifu
TEL
0584-84-3800
sayakakayasakayasa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayaka Yamaguchi |
Organization
Nonprofit organization Hablis,
Division name
Hablis
Zip code
Address
1-168-1, Uchihara, Ohgaki-city, Gifu
TEL
0584-84-3800
Homepage URL
sayakakayasakayasa@gmail.com
Sponsor or person
Institute
Nonprofit organization Hablis,
Institute
Department
Personal name
Funding Source
Organization
Kakenhi Grant from the Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
町立幼稚園および保育所（岐阜県関ヶ原町）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040777
| Research Plan | |
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| 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 |
