Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
Concerns of Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
1 other identifier
observational
64
1 country
1
Brief Summary
Children with esophageal atresia and tracheoesophageal fistula (EA-TEF) may experience feeding and swallowing difficulties, which result in stressful interactions between children and caregivers, and potentially impact the concerns of caregivers. The aim of this study was to assess concerns of caregivers of children with EA-TEF related to feeding-swallowing difficulties.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMay 10, 2019
May 1, 2019
1 month
March 22, 2019
May 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The Turkish Feeding/Swallowing Impact Survey
The Turkish Feeding/Swallowing Impact Survey (T-FS-IS) is used to describe the quality of life related to activities of daily living, worry and feeding difficulty of caregivers of children. It has 18 questions. Daily activities indicate caregivers' perceptions of time demands on daily activities. Worry is the worry of the caregivers about the children's well-being. Feeding difficulty is related to the challenges during delivery of care specific to feeding/swallowing. Each question of the instrument will be answered on a 5-point Likert scale between 1 to 5. A score of '1' indicates never, and a score of '5' indicates almost always. All scores from 18 questions in the T-FS-IS will be summed, and then divided by 18 to calculate an average total score. Scores within each subscale will also be added together, and then divided by the total number of questions in the subscale to calculate an average subscale score. Higher scores from the instrument represent decreased quality of life.
1 month
Study Arms (1)
Caregivers of children with EA-TEF
Caregivers of children with esophageal atresia and tracheoesophageal fistula will be included in the study.
Interventions
The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers
Eligibility Criteria
Caregivers of children with EA-TEF
You may qualify if:
- Having a child with EA-TEF
- Having a child with swallowing disorders aged between 6 months-18 years
You may not qualify if:
- Having a child without swallowing disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacetttepe University
Ankara, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SELEN S ARSLAN
Hacettepe University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 22, 2019
First Posted
March 25, 2019
Study Start
April 1, 2019
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
May 10, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share