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Family MobilePhone Otoscopy in Diagnostics of Otitis Media (FamilymOTO)

Primary Purpose

Otitis Media

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Teaching
(CellScopeOTO)
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Otitis Media focused on measuring otoscopy, otitis media, cellphone, family

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 6 - 35 mo
  • Parents have iPhone 5, 5s or 6
  • Child is in daycare
  • Child has had at least one acute otitis media within 90 days preceding the enrollment
  • Family agrees to give a mortgage of 40 euros from the CellScopeOTO

Exclusion Criteria:

  • Tympastonomy tube present in tympanic membrane
  • Chronic perforation of the tympanic membrane
  • Condition of head/neck anomaly to affect middle ear or ear canal anatomy
  • One child from the family already participating

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Teaching group

Control group

Arm Description

Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.

Families receive the cellphone otoscope as if they had bought it themselves from the internet. After the first study week, parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals.

Outcomes

Primary Outcome Measures

diagnostic quality of tympanic membrane imagines
diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope

Secondary Outcome Measures

Full Information

First Posted
May 20, 2015
Last Updated
November 15, 2016
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02452164
Brief Title
Family MobilePhone Otoscopy in Diagnostics of Otitis Media
Acronym
FamilymOTO
Official Title
Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a one-center clinical study carried out in Turku, Finland. The study patients will be randomly allocated to one of the two parallel study groups (teaching group and control group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better when parents have been taught to conduct middle ear examination with a cellphone otoscope (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the diagnostic feasibility of cellphone otoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
otoscopy, otitis media, cellphone, family

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teaching group
Arm Type
Active Comparator
Arm Description
Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.
Arm Title
Control group
Arm Type
Other
Arm Description
Families receive the cellphone otoscope as if they had bought it themselves from the internet. After the first study week, parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals.
Intervention Type
Other
Intervention Name(s)
Teaching
Intervention Type
Device
Intervention Name(s)
(CellScopeOTO)
Primary Outcome Measure Information:
Title
diagnostic quality of tympanic membrane imagines
Description
diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope
Time Frame
first study week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 6 - 35 mo Parents have iPhone 5, 5s or 6 Child is in daycare Child has had at least one acute otitis media within 90 days preceding the enrollment Family agrees to give a mortgage of 40 euros from the CellScopeOTO Exclusion Criteria: Tympastonomy tube present in tympanic membrane Chronic perforation of the tympanic membrane Condition of head/neck anomaly to affect middle ear or ear canal anatomy One child from the family already participating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aino Ruohola, MD, PhD
Organizational Affiliation
consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
Country
Finland

12. IPD Sharing Statement

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Family MobilePhone Otoscopy in Diagnostics of Otitis Media

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