Family MobilePhone Otoscopy in Diagnostics of Otitis Media (FamilymOTO)

Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)

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.

Study Overview

• Status: Completed
• Conditions: Otitis Media
• Intervention / Treatment: Other: Teaching; Device: (CellScopeOTO)

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Teaching group; Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.	Other: Teaching; Device: (CellScopeOTO)
Other: Control group; 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.	Device: (CellScopeOTO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic quality of tympanic membrane imagines	diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope	first study week

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Aino Ruohola, MD, PhD, Consultant

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 15, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: family; otitis media; otoscopy; cellphone
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: T91/2015