UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059133 |
|---|---|
| Receipt number | R000066904 |
| Scientific Title | Development of a Transition Support Program for Patients Who Undergoing Emergency Surgery for Acute Stanford Type A Aortic Dissection: From Intensive Care Unit to 3 Months Post-discharge |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/19 15:07:37 |
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Basic information
Public title
Development of a Recovery Support Program for Patients Who Undergoing Emergency Surgery for Acute Aortic Dissection
Acronym
Aortic Dissection Recovery Support Program Development Study
Scientific Title
Development of a Transition Support Program for Patients Who Undergoing Emergency Surgery for Acute Stanford Type A Aortic Dissection: From Intensive Care Unit to 3 Months Post-discharge
Scientific Title:Acronym
AADA Patient Transition Support Program Development Study
Region
| Japan |
Condition
Condition
Acute Stanford Type A Aortic Dissection
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a transition support program for patients undergoing emergency surgery for acute Stanford Type A aortic dissection and evaluate its effectiveness and clinical feasibility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ransition-related outcomes (Barthel Index, WHO QOL-26, qualitative narrative data)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A transition support program for patients undergoing emergency surgery for acute Stanford Type A aortic dissection.The program includes structured interviews at three time points: before ICU discharge, before hospital discharge, and 1 month post-discharge. Each interview focuses on meaning-making facilitation, transition preparation support, and social reintegration support. A personalized transition pamphlet is utilized to facilitate continuous information sharing among multidisciplinary teams. This comprehensive program supports both physical recovery and psychosocial adaptation in addition to standard medical and nursing care.
Interventions/Control_2
Standard medical and nursing care for patients who underwent emergency surgery for acute Stanford Type A aortic dissection. This includes ICU management of hemodynamics and respiratory function, delirium prevention, early rehabilitation, general ward support for activities of daily living, cardiac rehabilitation, complication prevention, discharge education, and medication guidance. Post-discharge care involves regular outpatient follow-up. No special transition support program is implemented; standard care is provided according to current clinical guidelines.
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
| 18 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent emergency surgery for acute Stanford Type A aortic dissection, 2) Adult patients up to 74 years old regardless of gender, 3) Patients capable of verbal communication and able to understand research explanations and provide consent, 4) Patients who can provide written informed consent for research participation
Key exclusion criteria
Patients judged inappropriate for this study by the attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kousei |
| Middle name | |
| Last name | Kudou |
Organization
Akita University
Division name
Akita University Graduate School of Health Sciences, Department of Nursing
Zip code
010-8543
Address
1-1-1 Hondo, Akita-shi, Aktia 010-8543, Japan
TEL
018-884-6520
kouseik@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kousei |
| Middle name | |
| Last name | Kudou |
Organization
Akita University
Division name
Graduate School of Medicine, Division of Health Sciences, Department of Nursing
Zip code
010-8543
Address
1-1 Hondo 1-chome, Akita-shi, Akita 010-8543, Japan
TEL
018-884-6520
Homepage URL
kouseik@hs.akita-u.ac.jp
Sponsor or person
Institute
Yamanashi Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Yamanashi Prefectural University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamanashi Prefectural University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Faculty of Nursing, Yamanashi Prefectural University
Address
5-11-1 Iida, Kofu, Yamanashi 400-0035, Japan
Tel
055-224-5310
keieikikaku@yamanashi-ken.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
| 2025 | Year | 10 | 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
| 2025 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066904
