NCT05770362

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 19, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 10, 2023

Last Update Submit

March 14, 2023

Conditions

Lifestyle-related ConditionCOVID-19 PandemicChildren With Developmental Delays

Keywords

COVID-19 pandemiclifestylesleepchildren with developmental delays

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

lifestyle questionnaireOTHER

The changes in lifestyle by lifestyle questionnaire during and after home isolation

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • children diagnosed with developmental delays

You may not qualify if:

  • children without developmental delays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Conditions

Mental DisordersCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ru-Lan Hsieh, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

886-2-28332211M001052@ms.skh.org.tw

Ru-Lan Hsieh, MD

CONTACT

M001052@ms.skh.org.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 15, 2023

Study Start

March 19, 2023

Primary Completion

July 19, 2023

Study Completion

July 19, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)