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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038358
Receipt No. R000043697
Scientific Title Effectiveness of the patient dispatch-type information provision tool about cardiac rehabilitation: A randomized controlled trial
Date of disclosure of the study information 2019/12/01
Last modified on 2019/10/22

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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
2019 Year 12 Month 01 Day
Last follow-up date
2020 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
2019 Year 10 Month 22 Day


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

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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