UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045640 |
|---|---|
| Receipt number | 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 | 2023/04/04 09:22:41 |
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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
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
fuqi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
800
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
No longer recruiting
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
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052060
