Exploring Interventions for Glue Ear During Covid-19
BIG-C
Exploring Interventions for Children With Chronic Otitis Media With Effusion ('Glue Ear') When Services Are Reduced During Covid-19
1 other identifier
interventional
20
1 country
1
Brief Summary
During the Coronavirus pandemic children's hearing services are closed or reduced and grommet operations are part of the lowest priority group. In the absence of management options, this research study aims to see if bone conduction headphones either paired (via bluetooth) to a microphone or an app will help children with a hearing loss during this period of waiting. The child's quality of life is measured with validated questionnaires The study is over 3 months, and delivered remotely, with the product being sent to the family home and support offered via telephone/ video consulattion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
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
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJune 11, 2020
June 1, 2020
6 months
June 3, 2020
June 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
acceptability of management strategy, questionnaire
questionnaire based accpetability question. A higher acceptability score will be positive for the intervention.
Acceptability will be measured on a Likert scale pre-assessment and the end of 3 months of using the intervention
Secondary Outcomes (1)
quality of life questionnaire OMQ-14
Questionnaires at beginning of study (as a baseline assessment and after 3 months of using the intervention. The sc
Study Arms (1)
Single arm study
EXPERIMENTALThe family will complete questionnaires before and after each childs intervention. Therefore each child will act as their own control.
Interventions
Children will be offered hearing support with bone conduction headphones that can either be paired to a microphone or to a tablet/ phone/ computer to help children to hear. The Hear Glue Ear app is available for free to provide speech and language enrichment.
Eligibility Criteria
You may qualify if:
- Age 3-11y
- English used as a main language (since app is only written in English)
- Glue ear with a hearing loss affecting at least 2 frequencies in at least one ear
You may not qualify if:
- age range outside the 3-11 y parameter
- normal hearing
- not using english as a main language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peacock Children's centre. Brookfields Hospital
Cambridge, Cambridgeshire, CB1 3DF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- It is too difficult to blind the assessor in thsi instance.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Paediatrician and chief investigator
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 11, 2020
Study Start
June 22, 2020
Primary Completion
January 1, 2021
Study Completion
June 1, 2021
Last Updated
June 11, 2020
Record last verified: 2020-06