UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055913 |
|---|---|
| Receipt number | R000063885 |
| Scientific Title | The changes over time in patients' motivation to engage in rehabilitation. |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2024/10/22 12:01:38 |
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Basic information
Public title
The changes over time in patients' motivation to engage in rehabilitation.
Acronym
The changes over time in patients' motivation to engage in rehabilitation.
Scientific Title
The changes over time in patients' motivation to engage in rehabilitation.
Scientific Title:Acronym
The changes over time in patients' motivation to engage in rehabilitation.
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate and verify the intra- and inter-day variations in motivation of patients engaged in rehabilitation and related events.
Basic objectives2
Others
Basic objectives -Others
Feasibility, safety, efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient motivation scores for rehabilitation obtained from an experience-sampling questionnaire survey.
Key secondary outcomes
Patients' pain status, fatigue, depressed mood, apathy, and activity status obtained from an empirical sampling questionnaire survey
Basic information on the participants (age, gender, disease, medical history, motor-cognitive function, life function, sleep and activities in the ward, and rehabilitation status are referenced from the medical record and hospital record system)
Results of tests of depression, apathy, and other psychiatric conditions at the beginning of the measurement period, and results of individual factor assessments (Brief Resilience Scale Japanese version (BRS-J), Big Five Ten Item Personality Inventory (TIPI-J), etc.).
Presence or absence of unusual events during the measurement period (e.g., falls, outings, etc.)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have been hospitalized for 2 to 6 weeks.
18-80 years of age who have given informed consent for this study.
Have access to a smartphone and agree to install the Exkuma experience sampling tool.
Key exclusion criteria
Participants who have difficulty in responding to the experience sampling due to cognitive decline or higher brain dysfunction.
Participants who are diagnotised to be in a depressed state.
Participants who are hospitalized for Parkinson's disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2167
otaka119@mac.com
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Yoshida |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9000
Homepage URL
taiki.yoshida@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsu University School of Medicine, Shinshu University, Toyo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98 Dengakugakubo, Kutukake-cho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学病院（愛知県），藤田医科大学七栗記念病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to investigate and validate the intra- and inter-day variation in motivation and related events.
Management information
Registered date
| 2024 | Year | 10 | Month | 22 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063885
