UMIN-CTR Clinical Trial

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
Email	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
Email	t_takeda@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University International medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045647