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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045640
Receipt No. R000052060
Scientific Title Multicenter cluster randomized control trial on the effect of engagement in surgical patients
Date of disclosure of the study information 2021/10/04
Last modified on 2021/10/02

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Basic information
Public title Multicenter cluster randomized control trial on the effect of engagement in surgical patients
Acronym Multicenter cluster RCT for sugical patient engagement(SPE-cRCT)
Scientific Title Multicenter cluster randomized control trial on the effect of engagement in surgical patients
Scientific Title:Acronym Multicenter cluster RCT for sugical patient engagement(SPE-cRCT)
Region
Japan

Condition
Condition Patients undergoing surgery
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the experience and surgical outcomes of patients in the educated and uneducated groups with pamphlets that promote patient involvement
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of Hospital Consumer Assessment of Healthcare Providers and Systems(HCAHPS))survey and EuroQol 5 Dimension survey at hospital discharge
Key secondary outcomes Adverse events incidence up to one month after surgery

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Preoperative education for patient engagement using the leaflet
Interventions/Control_2 Leaflet unused
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who can read and understand the Japanese version of the leaflet
2. Patients over 20 years old
3. Patients scheduled for surgery under general anesthesia
4. Patients without cognitive or psychomotor problems
5. Patients who can answer the survey on their own initiative
Key exclusion criteria 1. Patients under 20 years
2. Patients with cognitive and psychomotor problems
3. Patients who are judged to be inappropriate by the principal investigator, the research coordinator, and the clinical team
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Ayuko
Middle name
Last name Yasuda
Organization Fujita Health University Hospital
Division name Department of Quality and Safety in Healthcare
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukakecho,Toyoake, Aichi
TEL 0562939716
Email ayuko@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Nanami
Middle name
Last name Kurata
Organization Fujita Health University Hospital
Division name Department of Quality and Safety in Healthcare
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukakecho,Toyoake, Aichi
TEL 0562939716
Homepage URL
Email fuqi@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fujita Health University Medical Research Ethics Review Board
Address 1-98 Dengakugakubo, Kutsukakecho,Toyoake, Aichi
Tel 0562-93-2865
Email f-irb@fujita-hu.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 東北大学病院(宮城県)、日本歯科大学新潟病院(新潟)、金沢大学附属病院(石川県)、浜松医科大学医学部附属病院(静岡県)、藤田医科大学病院(愛知県)、川崎医科大学総合医療センター(岡山県)、熊本大学病院(熊本県)、宮崎大学医学部附属病院(宮崎県)、鹿児島大学病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 04 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
2021 Year 07 Month 28 Day
Date of IRB
2021 Year 09 Month 03 Day
Anticipated trial start date
2021 Year 11 Month 01 Day
Last follow-up date
2022 Year 07 Month 31 Day
Date of closure to data entry
2022 Year 11 Month 01 Day
Date trial data considered complete
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 10 Month 02 Day
Last modified on
2021 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052060

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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