NCT04686565

Brief Summary

Investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

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

Study Start

First participant enrolled

February 15, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

December 23, 2020

Last Update Submit

February 1, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • The status of the child to benefit from health-education services

    With the 14-question questionnaire prepared by the authors, the reasons such as whether there is a disruption in the control of the patients, the reason for the flow, the use of oral medications, the use of orthoses, the application of botulinum toxin, if they are applied, the development of side effects, and the obstacle to distance education will be questioned.

    10 seconds

  • Physical-psychosocial and cognitive state of the child

    With five questions prepared by the investigators themselves, primary caregivers will be asked to evaluate their children's disease status, mobility level, spasticity, range of motion, communication and emotional state as better, the same or worse compared to the pre-pandemic period.

    10 seconds

  • Caregivers' quality of life

    The quality of life of the primary caregivers of the patients during the Covid-19 period will be evaluated with the Short Form-12 using the phone and compared with the results recorded in their pre-pandemic files. It is an abbreviation of 12 questions of the 8-item, 36-question short form -36 developed to evaluate the positive and negative aspects of the health status. Patients are asked to be evaluated considering the last four weeks. The total score ranges from 0 to 100 and higher scores indicate better quality of life

    30 seconds

  • the Covid-19 fear levels of Caregivers

    Fear of Covid-19 scale is being used to evaluated the Covid-19 fear levels of Caregivers by telephone.It is a 7-question questionnaire evaluating the fear associated with covid-19, which is evaluated with a five-item Likert scale. The lowest score is 7, the highest score is 35. As the score increases, the level of fear due to Covid-19 increases. Turkish validity and reliability has been made.

    10 seconds

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients between the ages of 3-18 who are followed up with a diagnosis of cerebral palsy in our clinic and their primary caregivers will be included

You may qualify if:

  • Patients' ages between 3-18 years
  • Caregiver of Patients diagnosed as Cerebral palsy
  • Patients with routine follow-ups in our clinic
  • Caregivers can be reach by phone

You may not qualify if:

  • Patients' ages under 3 and over 18 years
  • Caregivers cannot be reach by phone
  • Caregivers without quality of life results for the pre-pandemic period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Education and Research Hospital

Ankara, Altındag, 06300, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Ben-Pazi H, Beni-Adani L, Lamdan R. Accelerating Telemedicine for Cerebral Palsy During the COVID-19 Pandemic and Beyond. Front Neurol. 2020 Jun 26;11:746. doi: 10.3389/fneur.2020.00746. eCollection 2020.

    PMID: 32670193BACKGROUND
  • Cacioppo M, Bouvier S, Bailly R, Houx L, Lempereur M, Mensah-Gourmel J, Kandalaft C, Varengue R, Chatelin A, Vagnoni J, Vuillerot C, Gautheron V, Dinomais M, Dheilly E, Brochard S, Pons C; ECHO Group. Emerging health challenges for children with physical disabilities and their parents during the COVID-19 pandemic: The ECHO French survey. Ann Phys Rehabil Med. 2021 May;64(3):101429. doi: 10.1016/j.rehab.2020.08.001. Epub 2020 Aug 18.

    PMID: 32818674BACKGROUND
  • Satici B, Gocet-Tekin E, Deniz ME, Satici SA. Adaptation of the Fear of COVID-19 Scale: Its Association with Psychological Distress and Life Satisfaction in Turkey. Int J Ment Health Addict. 2021;19(6):1980-1988. doi: 10.1007/s11469-020-00294-0. Epub 2020 May 8.

    PMID: 32395095BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyCOVID-19Developmental Disabilities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Damla Cankurtaran, MD

    Diskapi Yildirim Beyazit Education and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Ece uNLU aKYUZ, Assoc Prof.

    Diskapi Yildirim Beyazit Education and Research Hospital

    STUDY DIRECTOR
  • Nihal Tezel, MD

    Diskapi Yildirim Beyazit Education and Research Hospital

    STUDY CHAIR

Central Study Contacts

Damla Cankurtaran, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 28, 2020

Study Start

February 15, 2020

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations