UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040036 |
|---|---|
| Receipt number | R000045647 |
| Scientific Title | The relationship between occupational therapy participation and frailty in patients with cardiac implantable electrical device |
| Date of disclosure of the study information | 2020/04/02 |
| Last modified on | 2020/04/02 22:02:14 |
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Basic information
Public title
The relationship between occupational performance and frailty in patients with cardiac implantable electrical device
Acronym
Occupational performance and frailty in patients with cardiac implantable electrical device
Scientific Title
The relationship between occupational therapy participation and frailty in patients with cardiac implantable electrical device
Scientific Title:Acronym
Occupational therapy participation and frailty in patients with cardiac implantable electrical device
Region
| Japan |
Condition
Condition
Patients with cardiac implantable electrical device
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between occupational performance, frailty (physical, cognitive and social) and health related QOL in patients with cardiac implantable electrical device.
Basic objectives2
Others
Basic objectives -Others
Occupational self assessment Version 2.1
EuroQol-5
Short Physical Performance Battery
Lubben Social Network Scale
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty
Key secondary outcomes
Occupational performance
Health related QOL
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with pacemaker, Implantable Cardioverter Defibrillator, Cardiac
Resynchronization Therapy devices and generator replacement.
2. Patients aged 50 years or older at the time of participation in this study.
3. Peoples who had informed consent to this study.
Key exclusion criteria
1. Peoples who it is difficult to understand that question paper and contents of physical function assessment.
2. Peoples who has been certified as requiring long-term care.
3. Peoples who necessary ADL assistance.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takeda |
Organization
Saitama Medical University International medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4367
t_takeda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Takeda |
Organization
Saitama Medical University International medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4367
Homepage URL
t_takeda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International medical Center
Address
Yamane, Hidaka-City, Saitama-Pref, Japan
Tel
042-984-4523
chikens@saitama-med.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
| 2020 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the relationship between occupational performance, frailty (physical, cognitive and social) and health related QOL in patients with cardiac implantable electrical device.
Management information
Registered date
| 2020 | Year | 04 | Month | 02 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045647
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
