COVID-19NCT04525742
COVID-19 Pandemic and Parents of Disabled Children
A study testing Difficulties lived by disabled children's parents in the period of COVID-19 pandemic in people with COVID-19 and Disabilities Multiple, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pandemic period could affect the disabled children's rehabilitation and follow-up negatively because of preventive measures and this could create adverse results on their parents. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Disabilities Multiple, Cerebral Palsy
- What is being tested?
- Difficulties lived by disabled children's parents in the period of COVID-19 pandemic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2020to 15 Sep 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having disabled child/children
- Having ability and facility to use internet
- Having ability to read and write
- Having enough cognitive capacity to answer the questionnaire
- To accept to participate the research
Who cannot join
- Not having disabled child/children
- Not having ability and facility to use internet
- Not having ability to read and write
- Not having enough cognitive capacity to answer the questionnaire
- Not to accept to participate the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Gaziosmanpasa Training and Research Hospital
Istanbul, Gaziosmanpasa, 34255
About this study
Official title: COVID-19 Pandemic From the Perspective of Parents of Disabled Children
Pandemic period could affect the disabled children's rehabilitation and follow-up negatively because of preventive measures and this could create adverse results on their parents.
In this research, it is aimed to determine the positive and negative effects of pandemic on parents and disabled children and to provide an insight for future solutions.
Read the detailed description
To determine the effect of COVID-19 pandemic and the possible difficulties experienced by the parents of disabled children, a questionnaire was prepared. It takes approximately 10-15 minutes to complete the survey. Questionnaire is loaded to qualtrics program and sent to the families by e-mail or social media accounts.
- Conditions
- COVID-19, Disabilities Multiple, Cerebral Palsy, Muscular Dystrophies
- Being tested
- Difficulties lived by disabled children's parents in the period of COVID-19 pandemic
- Keywords
- cerebral palsy, COVID-19, pandemic, disability
- Medical subject headings
- COVID-19, Cerebral Palsy, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difficulties lived by disabled children's parents in the period of COVID-19 pandemicOther
It will be a cross sectional study to obtain the information on difficulties lived by disabled children's parents during recent pandemic period
| Study group | Role | What they receive |
|---|---|---|
| Parents who have a disabled child or children | Other | Parents having disabled child or children will be included in the research and it will be wanted to complete the survey questionary Receives: Other: Difficulties lived by disabled children's parents in the period of COVID-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
A questionnaire that we created will be used to determine the difficulties experienced by disabled children's parents during Covid 19 pandemic related to their medical follow-up
Difficulties related to rehabilitation facilities, other medical conditions or ortosis could increase because of Covid 19 pandemic unique conditions
Measured: 4 weeks
Secondary outcomes (1)
The Fear of COVID-19 Scale
The Fear of COVID-19 Scale, a seven-item scale, has robust psychometric properties. It is reliable and valid in assessing fear of COVID-19 among the general population and will also be useful in allaying COVID-19 fears among individuals. Score is minimum 7 pointts and maximum 35 points.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start5 Jul 2020
- Primary completion30 Aug 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One study group will be researched- only disabled children's parents, in one arm -way
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berrin Hüner, Gaziosmanpasa Research and Education Hospital
- Investigators
- Resa Aydin, Professor, Principal investigator, İstanbul University İstanbul Faculty of MedicineEvrim Karadağ Saygı, Professor, Principal investigator, Marmara University Faculty of MedicineÖzden Özyemisçi Taşkıran, Professor, Principal investigator, Koc University Faculty of MedicineNalan Çapan, Professor, Principal investigator, İstanbul University İstanbul Faculty of MedicineEbru Yilmaz Yalçınkaya, Professor, Study director, Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525742
- Sponsor's protocol ID
- 105
- Status last verified
- Oct 2020
- First submitted
- 28 Jun 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol was established by Berrin Huner and Ebru Yilmaz Yalcınkaya Statistical analysis (Power analysis) was established by Ozden Ozyemisci Taskiran Informed consent was written by Berrin Huner
Publications
Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
PubMed 32226353
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Pandemic From the Perspective of Parents of Disabled Children
- ClinicalTrials.gov ID
- NCT04525742
- Acronym / sponsor ID
- 105
- Conditions
- COVID-19, Disabilities Multiple, Cerebral Palsy, Muscular Dystrophies
- Keywords
- cerebral palsy, COVID-19, pandemic, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 5 Jul 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 25 Aug 2020 (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.
Pandemic period could affect the disabled children's rehabilitation and follow-up negatively because of preventive measures and this could create adverse results on their parents.
In this research, it is aimed to determine the positive and negative effects of pandemic on parents and disabled children and to provide an insight for future solutions.
Detailed description
To determine the effect of COVID-19 pandemic and the possible difficulties experienced by the parents of disabled children, a questionnaire was prepared. It takes approximately 10-15 minutes to complete the survey. Questionnaire is loaded to qualtrics program and sent to the families by e-mail or social media accounts.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One study group will be researched- only disabled children's parents, in one arm -way
| Arm | Type | Receives |
|---|---|---|
| Parents who have a disabled child or children | Other | Other: Difficulties lived by disabled children's parents in the period of COVID-19 pandemicParents having disabled child or children will be included in the research and it will be wanted to complete the survey questionary |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having disabled child/children
- Having ability and facility to use internet
- Having ability to read and write
- Having enough cognitive capacity to answer the questionnaire
- To accept to participate the research
Key exclusion criteria (5 listed)
- Not having disabled child/children
- Not having ability and facility to use internet
- Not having ability to read and write
- Not having enough cognitive capacity to answer the questionnaire
- Not to accept to participate the research
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 |
|---|---|---|
| Difficulties lived by disabled children's parents in the period of COVID-19 pandemicIt will be a cross sectional study to obtain the information on difficulties lived by disabled children's parents during recent pandemic period | Other | Parents who have a disabled child or children |
Primary outcome
A questionnaire that we created will be used to determine the difficulties experienced by disabled children's parents during Covid 19 pandemic related to their medical follow-up
Time frame: 4 weeks
Difficulties related to rehabilitation facilities, other medical conditions or ortosis could increase because of Covid 19 pandemic unique conditions
1 secondary outcome
The Fear of COVID-19 Scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 32226353Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
- Individual participant dataSharing planned: Yes. Study protocol was established by Berrin Huner and Ebru Yilmaz Yalcınkaya Statistical analysis (Power analysis) was established by Ozden Ozyemisci Taskiran Informed consent was written by Berrin Huner
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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.
Resa Aydin, Professor principal investigator
İstanbul University İstanbul Faculty of Medicine
Evrim Karadağ Saygı, Professor principal investigator
Marmara University Faculty of Medicine
Özden Özyemisçi Taşkıran, Professor principal investigator
Koc University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Difficulties lived by disabled children's parents in the period of COVID-19 pandemic in people with COVID-19 and Disabilities Multiple, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 3 Nov 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A questionnaire that we created will be used to determine the difficulties experienced by disabled children's parents during Covid 19 pandemic related to their medical follow-up (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525742, which also lists 1 linked publication.
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 3 Nov 2020.