NCT04525742

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
309

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

July 5, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

June 28, 2020

Last Update Submit

October 31, 2020

Conditions

Keywords

cerebral palsyCOVID-19pandemicdisability

Outcome Measures

Primary Outcomes (1)

  • 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

    4 weeks

Secondary Outcomes (1)

  • The Fear of COVID-19 Scale

    4 weeks

Study Arms (1)

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

Other: Difficulties lived by disabled children's parents in the period of COVID-19 pandemic

Interventions

It will be a cross sectional study to obtain the information on difficulties lived by disabled children's parents during recent pandemic period

Parents who have a disabled child or children

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University Gaziosmanpasa Training and Research Hospital

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 32226353BACKGROUND

MeSH Terms

Conditions

COVID-19Cerebral PalsyMuscular Dystrophies

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Resa Aydin, Professor

    İstanbul University İstanbul Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Evrim Karadağ Saygı, Professor

    Marmara University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Özden Özyemisçi Taşkıran, Professor

    Koc University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Nalan Çapan, Professor

    İstanbul University İstanbul Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Ebru Yilmaz Yalçınkaya, Professor

    Health Science University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking will be done
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: One study group will be researched- only disabled children's parents, in one arm -way
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 28, 2020

First Posted

August 25, 2020

Study Start

July 5, 2020

Primary Completion

August 30, 2020

Study Completion

September 15, 2020

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Research is planned to bu conducted between June 15 th and July 15 th 2020. After 15 th of July in 1 week coming statistical analysis will be finished and than in 3 weeks article will be written
Access Criteria
In necessary cases colleced data from the research will be shared with the local ethical committe

Locations