Lifestyle-related ConditionCOVID-19NCT05770362
Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays
An observational study of Lifestyle-related Condition and COVID-19 Pandemic, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
To evaluate the lifestyle changes caused by the COVID-19 pandemic in children with developmental delays in Taiwan. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Lifestyle-related Condition, COVID-19 Pandemic, Children With Developmental Delays
- What is being tested?
- lifestyle questionnaire
- How many people
- 260 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Mar 2023to 19 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital in Taiwan.
Who may be able to join
- children diagnosed with developmental delays
Who cannot join
- children without developmental delays
Trial locations and contacts
1 site in 1 country.
Ru-Lan Hsieh, MD contact
About this study
To evaluate the lifestyle changes caused by the COVID-19 pandemic in children with developmental delays in Taiwan.
Read the 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.
- Being tested
- lifestyle questionnaire
- Keywords
- COVID-19 pandemic, lifestyle, sleep, children with developmental delays
- Medical subject headings
- Mental Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle questionnaireOther
The changes in lifestyle by lifestyle questionnaire during and after home isolation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during and after home isolation through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start19 Mar 2023 (estimated)
- Primary completion19 Jul 2023 (estimated)
- Study completion19 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle-related ConditionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770362
- Sponsor's protocol ID
- MHW-111
- Acronym
- COVID-19
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays
- ClinicalTrials.gov ID
- NCT05770362
- Acronym / sponsor ID
- COVID-19 / MHW-111
- Keywords
- COVID-19 pandemic, lifestyle, sleep, children with developmental delays
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 19 Mar 2023 (estimated)
- Primary completion
- 19 Jul 2023 (estimated)
- Study completion
- 19 Jul 2023 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital in Taiwan.
Key inclusion criteria (1 listed)
- children diagnosed with developmental delays
Key exclusion criteria (1 listed)
- children without developmental delays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle questionnaireThe changes in lifestyle by lifestyle questionnaire during and after home isolation | Other | – |
Primary outcome
sleeping quality change by lifestyle questionnaire
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Lan Hsieh, MD contact
Ru-Lan Hsieh, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lifestyle-related Condition and COVID-19 Pandemic, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan Hsieh, MD (886-2-28332211 ext. 2538, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleeping quality change by lifestyle questionnaire (time frame: during and after home isolation through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.