NCT05771727

Brief Summary

Parents of children with neuromuscular disease have been already at risk of depression, anxiety and burden. Additionally, the daily lives of children with neuromuscular disease and their parents have been significantly affected by the COVID-19 pandemic. Therefore, this study investigated parents' perspective on the effect of the COVID-19 pandemic on children with neuromuscular diseases and themselves.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

March 14, 2023

Last Update Submit

March 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The questionnaire which created by the researchers

    The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families.

    30 minutes

Secondary Outcomes (1)

  • Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9)

    5 minutes

Study Arms (1)

Parents of children with pediatric neuromuscular diseases

Parents of a total of 169 children with pediatric neuromuscular diseases, including 63 Duchnenne Muscular Dystrophy, 53 Spinal Muscular Atrophy and 18 other pediatric neuromuscular diseases (Congenital Muscular Dystrophy, Hereditary Motor and Sensory Neuropathy, Becker Muscular Dystrophy, Limb-Girdle Muscular Dystrophy, etc.) were included in the study

Other: survey

Interventions

surveyOTHER

The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families. This survey also included the Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9).

Parents of children with pediatric neuromuscular diseases

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Parents of children with pediatric neuromuscular diseases

You may qualify if:

  • taking care for a child with NMD whose age was between 0-18 years,
  • having the ability to read and write Turkish language,
  • having access to phone or e-mail,
  • being volunteer.

You may not qualify if:

  • having a child who have an additional diagnosis besides NMD and taking care of any other person in the family.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06680, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 16, 2023

Study Start

July 1, 2021

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations