UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028997 |
|---|---|
| Receipt number | R000033100 |
| Scientific Title | Evaluation of the effects of transitional care outpatient clinic among patients with childhood-onset chronic disease: Randomized controlled trial |
| Date of disclosure of the study information | 2017/09/05 |
| Last modified on | 2023/09/13 09:28:44 |
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Basic information
Public title
Evaluation of the effects of transitional care outpatient clinic among patients with childhood-onset chronic disease: Randomized controlled trial
Acronym
Evaluation of the effects of transitional care outpatient clinic among patients with childhood-onset chronic disease: Randomized controlled trial
Scientific Title
Evaluation of the effects of transitional care outpatient clinic among patients with childhood-onset chronic disease: Randomized controlled trial
Scientific Title:Acronym
Evaluation of the effects of transitional care outpatient clinic among patients with childhood-onset chronic disease: Randomized controlled trial
Region
| Japan |
Condition
Condition
childhood-onset chronic disease
Classification by specialty
| Pediatrics | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of transitional care outpatient clinic for patients with childhood-onset chronic disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Transition-Q
: pre-post intervention (2 times transitional care outpatient clinics)
Key secondary outcomes
1) Sense of Coherence Scale
2) Independent Consciousness Scale
3) Rosenberg Self-esteem Scale
4) Behavioral outcomes at regular outpatient clinics
: pre-post intervention (2 times transitional care outpatient clinics)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
<Intervention group>
1) Patients participate in transitional care outpatient clinics two times
2) Patients discuss about below contents with doctor and nurse in transitional care outpatient clinics
-details of their disease
-purpose of treatment, operation or medication
-future perspective (scholastic plan, job, marriage, pregnancy)
3) Patients create a my health passport which include important information regarding their disease
4) Patients receive a pamphlet about transitional care
Interventions/Control_2
<Intervention group>
patients receive a pamphlet about transitional care
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 12-18 years patients with childhood-onset chronic disease who visits regularly pediatrics or pediatric surgery outpatient clinics
2)Patients expected to continue to visit outpatient clinics regularly even after becoming an adult
3) Have more than 3 times visiting to hospital in a year
4) Can answer the Japanese questionnaire
5) Could have agreement of their guardian (s)
Key exclusion criteria
1) Patients who are judged difficult for participating in the study by their doctor due to the medical or mental condition
2) Patients who aren't informed of their disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoko Kamibeppu |
Organization
The University of Tokyo
Graduate School of Medicine
School of Health Sciences and Nursing
Division name
Department of Family Nursing
Zip code
Address
7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan
TEL
03-5841-3556
kkamibeppu-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Nakamura |
Organization
The University of Tokyo Graduate School of Medicine School of Health Sciences and Nursing
Division name
Department of Family Nursing
Zip code
Address
7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan
TEL
03-5841-3399
Homepage URL
nakamura-0817@umin.ac.jp
Sponsor or person
Institute
Department of Family Nursing
School of Health Sciences and Nursing
Graduate School of Medicine
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESEARCH FUND
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
Address
Tel
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
| 2017 | Year | 09 | Month | 05 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033100
