Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000972022
Ethics application status
Approved
Date submitted
9/11/2010
Date registered
11/11/2010
Date last updated
18/11/2010
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)
U1111-1117-2499
Trial acronym
MOP-UP
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

Intervention/exposure
Study type
Interventional
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
Behaviour
Comparator / control treatment
Standard care, no mobile phone messages.
Control group
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

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
Parallel
Other design features
Stratified by community
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
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
Country [1] 257727 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research
Address
PO Box 41096
Casuarina
Northern Territory, 0811
Country
Australia
Secondary sponsor category [1] 256942 0
None
Name [1] 256942 0
Address [1] 256942 0
Country [1] 256942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259778 0
HREC of NT DHF and MSHR (EC 00153)
Ethics committee address [1] 259778 0
PO Box 41096
Casuarina
Northern Territory, 0811
Ethics committee country [1] 259778 0
Australia
Date submitted for ethics approval [1] 259778 0
Approval date [1] 259778 0
18/02/2009
Ethics approval number [1] 259778 0
08-82

Summary
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
none
Trial related presentations / publications
none
Public notes

Contacts
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
Casuarina
Northern Territory, 0811
Country 14954 0
Australia
Phone 14954 0
+61 8 89 228 196
Fax 14954 0
+61 8 89 275 187
Email 14954 0
[email protected]
Contact person for scientific queries
Name 5882 0
Amanda Leach
Address 5882 0
Menzies School of Health Research
POBox 41096
Casuarina
Northern Territory, 0811
Country 5882 0
Australia
Phone 5882 0
+61 8 89 228 196
Fax 5882 0
+61 8 89 275 187
Email 5882 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.