Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays
Sponsor
Taipei Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05770362
Collaborator
(none)
260
1
4
64.9
Study Details
Study Description
Brief Summary
To evaluate the lifestyle changes caused by the COVID-19 pandemic in children with developmental delays in Taiwan.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
260 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays
Anticipated Study Start Date
:
Mar 19, 2023
Anticipated Primary Completion Date
:
Jul 19, 2023
Anticipated Study Completion Date
:
Jul 19, 2023
Outcome Measures
Primary Outcome Measures
- sleeping quality change by lifestyle questionnaire [during and after home isolation through study completion, an average of 6 months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- children diagnosed with developmental delays
Exclusion Criteria:
- children without developmental delays
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shin Kong Wu Ho-Su Memorial Hospital | Taipei | Taiwan | 111-01 |
Sponsors and Collaborators
- Taipei Medical University
Investigators
- Principal Investigator: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ru-Lan Hsieh,
MD, Professor,
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05770362
Other Study ID Numbers:
- MHW-111
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ru-Lan Hsieh,
MD, Professor,
Taipei Medical University
Additional relevant MeSH terms: