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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name