UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of the patient dispatch-type information provision tool about cardiac rehabilitation: A randomized controlled trial
Acronym	Effectiveness of the patient dispatch-type information provision tool about cardiac rehabilitation: A randomized controlled trial
Scientific Title	Effectiveness of the patient dispatch-type information provision tool about cardiac rehabilitation: A randomized controlled trial
Scientific Title:Acronym	Effectiveness of the patient dispatch-type information provision tool about cardiac rehabilitation: A randomized controlled trial
Region	Japan

Condition
Condition	Ischemic heart disease
Classification by specialty	Cardiology Rehabilitation medicine Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Currently, only few patients with ischemic heart disease participate in outpatient cardiac rehabilitation (CR) after treatment. Therefore, the effect of patient-oriented information provision tool (video) on these patients using their narratives of the experience of outpatient CR was examined.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome was that study participants participated in at least one outpatient cardiac rehabilitation within one month of discharge. Or make a reservation for outpatient CR within one month after discharge and have participated in the outpatient CR at least once within two months.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	(1) A group of healthcare professionals watching videos and explaining outpatient CR (control group: Group B)
Interventions/Control_2	(2) In addition to (1) above, a group that watches videos including patients' outpatient CR experiences (intervention group: Group A)
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Among hospitalized patients, those who had undergone PCI for ischemic heart disease are eligible for outpatient CR.
Key exclusion criteria	The following people will be excluded from the target. a) Those who underwent coronary artery bypass grafting during hospitalization b) Those with mental illnesses (diagnosis of schizophrenia, dementia, etc.) c) Those who cannot answer in Japanese d) Those who have difficulty viewing videos owing to disability
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yasuko Middle name Last name Ogata
Organization	Tokyo Medical and Dental University
Division name	Gerontological Nursing and Care System Development,Graduate School of Health Care Sciences
Zip code	113-8510
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL	03-5803-5358
Email	yogata.gh@tmd.ac.jp

Public contact
Name of contact person	1st name Noriko Middle name Last name Ishii
Organization	Tokyo Medical and Dental University
Division name	Gerontological Nursing and Care System Development,Graduate School of Health Care Sciences
Zip code	113-8510
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL	03-3813-6111(7228)
Homepage URL
Email	norikoishii.gh@tmd.ac.jp

Sponsor
Institute	Gerontological Nursing and Care System Development,Graduate School of Health Care Sciences,Tokyo Medical and Dental Univercity
Institute
Department

Funding Source
Organization	The Taiyo Life Welfare Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of the Faculty of Medicine, Tokyo Medical and Dental University
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo
Tel	+61-3-9076-3619
Email	info.bec@tmd.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	2019 Year 12 Month 01 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	Preinitiation
Date of protocol fixation	2019 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 30 Day
Last follow-up date	2022 Year 08 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	2019 Year 10 Month 22 Day
Last modified on	2021 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043697