UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038358 |
|---|---|
| Receipt number | 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 | 2021/05/09 14:44:27 |
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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
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
norikoishii.gh@tmd.ac.jp
Sponsor or person
Institute
Gerontological Nursing and Care System Development,Graduate School of Health Care Sciences,Tokyo Medical and Dental Univercity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043697
