NCT02452164

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

May 20, 2015

Last Update Submit

November 15, 2016

Conditions

Otitis Media

Keywords

otoscopyotitis mediacellphonefamily

Outcome Measures

Primary Outcomes (1)

  • diagnostic quality of tympanic membrane imagines

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

    first study week

Study Arms (2)

Teaching group

ACTIVE COMPARATOR

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

Other: TeachingDevice: (CellScopeOTO)

Control group

OTHER

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)

Interventions

TeachingOTHER
Teaching group
(CellScopeOTO)DEVICE
Control groupTeaching group

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Educational Status

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Aino Ruohola, MD, PhD

    consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 22, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

FI(1)