UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029443 |
|---|---|
| Receipt number | R000033631 |
| Scientific Title | Assessment of the effect of cognitive behavioral therapy on healthcare movements |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2019/04/07 10:57:35 |
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Basic information
Public title
Assessment of the effect of cognitive behavioral therapy on healthcare movements
Acronym
CBT on healthcare movements
Scientific Title
Assessment of the effect of cognitive behavioral therapy on healthcare movements
Scientific Title:Acronym
CBT on healthcare movements
Region
| Japan |
Condition
Condition
Myotonic dystrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing a program of cognitive behavioral therapy for patients with myotonic dystrophy to facilitate selfcare movements
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The achievement rate of targeted amount of activities measured by wearable terminals during two months intervention period
Key secondary outcomes
The achievement rate of targeted body weight at the endpoint of intervention period
The before-after analysis in HbA1c
The before-after analysis of neuropsychological test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive behavioral therapy
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients understanding the protocol and giving informed consent
Patients who can stand without any assistances and monitor their body weight
Key exclusion criteria
Patients with dementia and severe comorbidities
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Matsumura |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Neurology
Zip code
560-8552
Address
Toneyama 5-1-1, Toyonaka, Osaka
TEL
06-6853-2001
tmatsumura-toneyama@umin.org
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Takehara |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Clinical Research
Zip code
560-8552
Address
Toneyama 5-1-1, Toyonaka, Osaka
TEL
06-6853-2001
Homepage URL
http://www.toneyama-hosp.jp/patient/clinical/index.html
chiken@toneyama.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Graduate School of Medicine, Osaka University
National Hospital Organization Okinawa National Hospital
Nara University
Faculty of Education, Oita University
Okinawa International University
Grobal Center for Medical Engineering and Informatics, Osaka Univiersity
Graduate School of Medicine, Kyoto University
Yokohama Rosai Hospital
National Hosiptal Organization Suzuka National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Osaka Toneyama Medical Center
Address
Toneyama 5-1-1, Toyonaka, Osaka, Japan
Tel
+81668532001
tmatsumura-toneyama@umin.org
Secondary IDs
Secondary IDs
YES
Study ID_1
1724
Org. issuing International ID_1
National Hospital Organization Osaka Toneyama Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構大阪刀根山医療センター(大阪府)、大阪大学医学部附属病院(大阪府)、国立病院機構沖縄病院(沖縄県)、国立病院機構鈴鹿病院(三重県)、横浜労災病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 11 | 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
9
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
| 2017 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2020 | 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
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2019 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033631
| Research Plan | |
|---|---|
| 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 |
