Lifestyle Changes by the COVID-19 (Coronavirus Disease 20... | NCT05770362

Studies
Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays

NCT05770362

Sponsor

Taipei Medical University

Status

Unknown status

Last Update Posted

Mar 16, 2023Actual

Enrollment

260Estimated

Phase

Not provided

Conditions

Lifestyle-related Condition
COVID-19 Pandemic
Children With Developmental Delays

Interventions

lifestyle questionnaire

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2023Estimated

Primary Completion Date

Jul 19, 2023Estimated

Completion Date

Jul 19, 2023Estimated

First Submitted Date

Mar 10, 2023

First Submission Date that Met QC Criteria

Mar 12, 2023

First Posted Date

Mar 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the lifestyle changes caused by the COVID-19 pandemic in children with developmental delays in Taiwan.

Detailed Description

Two hundred and sixty children with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital will be included. The lifestyle questionnaire will evaluate the lifestyle changes of children with developmental delays during home isolation and release from home isolation during the COVID-19 pandemic in Taiwan. The parents of children with developmental delays will fill out the questionnaire.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lifestyle questionnaire	Other	The changes in lifestyle by lifestyle questionnaire during and after home isolation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sleeping quality change by lifestyle questionnaire	Sleep quality changes during and after home isolation during the COVID-19 pandemic by lifestyle questionnaire. The minimum and maximum values range from 1 to 5; higher scores mean a worse outcome.	during and after home isolation through study completion, an average of 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children diagnosed with developmental delays

Exclusion Criteria:

children without developmental delays

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Children diagnosed with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital in Taiwan.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ru-Lan Hsieh, MD	Contact	886-2-28332211	2538	M001052@ms.skh.org.tw
Ru-Lan Hsieh, MD	Contact			M001052@ms.skh.org.tw

Overall Officials

Name	Affiliation	Role
Ru-Lan Hsieh, MD	Shin Kong Wu Ho-Su Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shin Kong Wu Ho-Su Memorial Hospital		Taipei		111-01	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided