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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029443
Receipt No. 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

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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
Email 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
Email chiken@toneyama.go.jp

Sponsor
Institute National Hospital Organization Osaka Toneyama Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033631

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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