UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000050385
Receipt number R000057144
Scientific Title A scoping review of the burden and coping of disease management by parents of children with both developmental disabilities and allergic disorders.
Date of disclosure of the study information 2023/02/20
Last modified on 2024/01/10 18:24:51

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Basic information

Public title

A scoping review of the burden and coping of disease management by parents of children with both developmental disabilities and allergic disorders.

Acronym

A scoping review of the burden and coping of disease management by parents of children with both developmental disabilities and allergic disorders.

Scientific Title

A scoping review of the burden and coping of disease management by parents of children with both developmental disabilities and allergic disorders.

Scientific Title:Acronym

A scoping review of the burden and coping of disease management by parents of children with both developmental disabilities and allergic disorders.

Region

Japan


Condition

Condition

Children with developmental disabilities and allergies and their parents.

Classification by specialty

Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study clarifies the problem of children with both developmental disabilities and allergic disorders.
Identify the burden and coping strategies of parents of children with both developmental disabilities and allergic disorders on disease management.

Basic objectives2

Others

Basic objectives -Others

Identify problems of children with both developmental disabilities and allergic disorders, and the burden, coping that their parents face in disease management.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The problems of children with both developmental disabilities and allergic disorders, and the burden and coping of their parents in disease management.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1 months-old <=

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

Population
Children from 0 to 18 years old and their parents.
Concept
The following search terms were used developmental disorders, attention deficit hyperactivity disorder, autism spectrum disorder, learning disabilities, allergy, asthma, atopic dermatitis, allergic rhinitis, allergy to pollen, allergic conjunctivitis, food allergy, parent, burden, caregiver burden, coping, management, disease management, children, problem, problem behavior.
Context
Literature on children with both developmental disabilities and allergic disorders and their parents.
Written in Japanese or English.
Excluding review articles, commentaries, and conference proceedings.

Key exclusion criteria

Research using languages other than Japanese or English.
Excluding review articles, commentaries, and conference proceedings.

Target sample size



Research contact person

Name of lead principal investigator

1st name Tomomi
Middle name
Last name Fujimaki

Organization

Tokyo Healthcare University

Division name

School of Health Care

Zip code

141-8648

Address

4-1-17, Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8648, Japan

TEL

03-5421-7655

Email

t-fujimaki@thcu.ac.jp


Public contact

Name of contact person

1st name Tomomi
Middle name
Last name Fujimaki

Organization

Tokyo Healthcare University

Division name

School of Health Care

Zip code

141-8648

Address

4-1-17, Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8648, Japan

TEL

03-5421-7655

Homepage URL


Email

t-fujimaki@thcu.ac.jp


Sponsor or person

Institute

Tokyo Healthcare University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Healthcare University

Address

4-1-17, Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8648, Japan

Tel

03-5421-7655

Email

t-fujimaki@thcu.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

2023 Year 02 Month 20 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

21

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

2023 Year 02 Month 20 Day

Date of IRB

2023 Year 02 Month 20 Day

Anticipated trial start date

2023 Year 02 Month 20 Day

Last follow-up date

2023 Year 02 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This scoping review will search and extract the problems of children with both developmental and allergic disorders and the burden and coping of their parents in disease management using medical journals, pubmed and CINAHL. The results will then be used to suggest future research.


Management information

Registered date

2023 Year 02 Month 20 Day

Last modified on

2024 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057144


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name