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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
MObile Phones for Untreated Perforations (MOP-UP), a pilot randomised controlled trial to assess the effect of mobile phone calls or messaging (in local language) on clinic attendance for ear health checks in Aboriginal children.
Scientific title
In Aboriginal children with acute or chronic suppurative otitis media (CSOM), do additional text messaging or phone calls (compared to standard care) improve clinic attendance for ear health checks, a pilot randomised controlled trial.
Secondary ID [1] 252773 0
HREC of NT DHF and MSHR (EC 00153) - 08-82
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis media with perforation of the tympanic membrane. 258273 0
Condition category
Condition code
Ear 258464 258464 0 0
Other ear disorders

Study type
Description of intervention(s) / exposure
Standard care (verbal advice in plain english about importance of ear health, instruction on ear cleaning and prescription for topical antibiotics).
Mobile phone messages (SMS, MMS and voice mail) - up to 4 messages per week for 6 weeks. Content being reminders, information, support of regular treatment.
Intervention code [1] 257288 0
Treatment: Other
Intervention code [2] 257587 0
Other interventions
Intervention code [3] 257588 0
Comparator / control treatment
Standard care, no mobile phone messages.
Control group

Primary outcome [1] 259300 0
Clinic attendance for scheduled follow-up ear examinations measured as the proportion of once-weekly recommended appointments that are attended during the 6 week intervention period. Attendance will be determined by accessing electronic patient information system and recording attendance for ear infections.
Timepoint [1] 259300 0
Six weeks
Secondary outcome [1] 265728 0
Improved ear health (reduced ear discharge, reduced perforation size, or healed tympanic membrane) assessed by trained ear research nurses using standardised assessment forms.
Timepoint [1] 265728 0
Six weeks
Secondary outcome [2] 265729 0
Satisfaction with mobile phone messages assessed by face to face structured interviews with interpreter if requested.
Timepoint [2] 265729 0
Six weeks

Key inclusion criteria
Aboriginal children less than 13 years of age, living in a remote Indigenous community, with tympanic membrane perforation (TMP) and having a parent/carer who has a mobile phone.
Minimum age
0 Days
Maximum age
13 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concelaed in double sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer generated random number sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Stratified by community
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257727 0
Government body
Name [1] 257727 0
Australian Government Department of Health and Ageing
Address [1] 257727 0
Office of Hearing Services
Central Office postal address
GPO Box 9848,
Canberra ACT 2601
Country [1] 257727 0
Primary sponsor type
Menzies School of Health Research
PO Box 41096
Northern Territory, 0811
Secondary sponsor category [1] 256942 0
Name [1] 256942 0
Address [1] 256942 0
Country [1] 256942 0

Ethics approval
Ethics application status
Ethics committee name [1] 259778 0
HREC of NT DHF and MSHR (EC 00153)
Ethics committee address [1] 259778 0
PO Box 41096
Northern Territory, 0811
Ethics committee country [1] 259778 0
Date submitted for ethics approval [1] 259778 0
Approval date [1] 259778 0
Ethics approval number [1] 259778 0

Brief summary
Aboriginal children living in remote areas of the Northern Territory have the world’s highest rates of eardrum perforation reported in the medical literature. The disease can have significant effects on a child’s hearing, language, education and associated social disadvantage.

Studies show that a child with chronic suppurative otitis media (CSOM) requires frequent daily ear cleaning and antibiotic drops. This may be needed for many months. Regular review of the eardrum is required to monitor progress and provide treatment. Families living in remote communities struggle to provide the level of care needed for effective cure of perforations. Our research will look at ways to increase the rates of Aboriginal children with a history of eardrum perforation participating in follow-up exams. We will randomise families caring for a child with CSOM to receive regular reminders by mobile phone calls, text messages or standard practice. Clinic attendance rates will be the primary outcome.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31707 0
Address 31707 0
Country 31707 0
Phone 31707 0
Fax 31707 0
Email 31707 0
Contact person for public queries
Name 14954 0
Amanda Leach
Address 14954 0
Menzies School of Health Research
POBox 41096
Northern Territory, 0811
Country 14954 0
Phone 14954 0
+61 8 89 228 196
Fax 14954 0
+61 8 89 275 187
Email 14954 0
Contact person for scientific queries
Name 5882 0
Amanda Leach
Address 5882 0
Menzies School of Health Research
POBox 41096
Northern Territory, 0811
Country 5882 0
Phone 5882 0
+61 8 89 228 196
Fax 5882 0
+61 8 89 275 187
Email 5882 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary