UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050918 |
|---|---|
| Receipt number | R000057955 |
| Scientific Title | Multidisciplinary transition program for childhood-onset neurological conditions in a medical facility for people with disabilities |
| Date of disclosure of the study information | 2023/04/25 |
| Last modified on | 2024/04/06 22:01:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A before-and-after comparative study of the effects of the transition program on "Triple aim (experience of care, population health, service utilization)" of transition for individuals with childhood-onset neurological conditions
Acronym
Transition program for individuals with childhood-onset neurological conditions
Scientific Title
Multidisciplinary transition program for childhood-onset neurological conditions in a medical facility for people with disabilities
Scientific Title:Acronym
Multidisciplinary transition program for childhood-onset neurological conditions
Region
| Japan |
Condition
Condition
Childhood-onset neurological conditions
Classification by specialty
| Medicine in general | Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To examine whether the implementation of structured transition program for patients with childhood-onset neurological conditions improves patient and family self-care and quality of life.
2. To examine whether the implementation of structured transition program for patients with childhood-onset neurological conditions improves unmet health needs and health status.
3. To examine whether the implementation of structured transition program for patients with childhood-onset neurological conditions improves the use of health and welfare resources.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Experience of care (i.e., quality of life, Self-care assessment)
Health status (i.e., unmet health needs, frequency of fevers)
Service utilization (i.e., utilization of medical and welfare resources)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The transition program will be conducted in conjunction with regular clinical practice. The program includes content related to health care transition from pediatrics to adult practice and is conducted approximately four times. A multispecialty team member will provide education session or consultation in the outpatient clinic or in the hospital ward.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with childhood-onset neurological conditions under 40 years of age and their families who make a first visit to our department seeking for treatment in an adult department or to use social services, who wish to participate in the transition program and have given consent to participate in the study will be eligible.
Key exclusion criteria
Patients/families with urgent medical or social problems (i.e., urgent need for medical intervention, or suspected abuse) are not eligible in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Osako |
Organization
Tokyo Metropolitan Kita Medical and Rehabilitation Center for the Disabled
Division name
Internal medicine/ Neurology
Zip code
1140033
Address
1-2-3 Jujodai, Kita-ku, Tokyo
TEL
0339083001
Miho_1_Oosako@member.metro.tokyo.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Osako |
Organization
Tokyo Metropolitan Kita Medical and Rehabilitation Center for the Disabled
Division name
Internal medicine/ Neurology
Zip code
1140033
Address
1-2-3 Jujodai, Kita-ku, Tokyo
TEL
0339083001
Homepage URL
Miho_1_Oosako@member.metro.tokyo.jp
Sponsor or person
Institute
Tokyo Metropolitan Kita Medical and Rehabilitation Center for the Disabled
Institute
Department
Personal name
Funding Source
Organization
Sasakawa Health 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
Tokyo Metropolitan Kita Medical and Rehabilitation Center for the Disabled
Address
1-2-3 Jujodai, Kita-ku, Tokyo
Tel
0339083001
S0000334@section.metro.tokyo.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
| 2023 | Year | 04 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057955
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
