Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000163202
Ethics application status
Approved
Date submitted
21/11/2017
Date registered
2/02/2018
Date last updated
2/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of an automated SMS messaging tool in the use of asthma plans in a patient population attending a busy suburban Brisbane General Practice
Scientific title
A randomised controlled trial to evaluate the effect of an automated SMS messaging tool on engagement in primary care in patients with asthma attending a busy suburban Brisbane General Practice
Secondary ID [1] 293100 0
None
Universal Trial Number (UTN)
U1111-1203-4568
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 305041 0
Condition category
Condition code
Respiratory 304368 304368 0 0
Asthma
Public Health 305491 305491 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test an administrative intervention using automated SMS to improve patient engagement in primary care. A simple short messenger service (SMS) will be sent by the general practice clinic to prompt patients to attend for a planned asthma review, and obtain an up-to-date asthma action plan. Any patients who do not respond will be sent a second and final SMS reminder one month later.
Intervention code [1] 299345 0
Behaviour
Comparator / control treatment
Care as usual. Participants randomised to the care as usual group will continue to receive opportunistic care from their regular doctors.
Control group
Active

Outcomes
Primary outcome [1] 303615 0
Attended the clinic for a planned asthma care review as recorded in the patients' medical records.
Timepoint [1] 303615 0
3 months post-intervention.
Secondary outcome [1] 339624 0
Obtained a current asthma action plan as recorded in the patients' medical records.
Timepoint [1] 339624 0
3 months post-intervention.

Eligibility
Key inclusion criteria
(a) 18 years of age or over
(b) Active patients of the practice (defined by attending at least twice in the past two years)
(c) Have a mobile phone number attached to their practice file
(d) Have already consented to the use of their phone number for contact from the practice
(e) Have asthma as a diagnosis in their past active medical history
(f) Have not completed an asthma management plan in the last 12 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised by computer to either intervention (SMS receiving group) or care as usual. Allocation to group will be concealed from research staff and participants as group allocations will be randomly generated by a computerised system at conclusion of recruitment of participants into the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using intention to treat and a chi-squared test for differences in proportions between the intervention vs care as usual (control) groups for (a) attendance at the clinic for a planned asthma review and (b) obtaining an up-to-date asthma action plan.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/05/2016
Date of last participant enrolment
Anticipated
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
31/08/2016
Sample size
Target
300
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 17693 0
4014 - Banyo

Funding & Sponsors
Funding source category [1] 297727 0
Other Collaborative groups
Name [1] 297727 0
RACGP/IPN Medical Centres Research Grant
Country [1] 297727 0
Australia
Primary sponsor type
Individual
Name
Dr Ben Mitchell
Address
Primary Care Clinical Unit
School of Medicine
The University of Queensland
288 Herston Rd
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 296755 0
Individual
Name [1] 296755 0
Dr John Carter
Address [1] 296755 0
Banyo Clinic
183 Tufnell Rd
Banyo QLD 4014
Country [1] 296755 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298794 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 298794 0
Ethics committee country [1] 298794 0
Australia
Date submitted for ethics approval [1] 298794 0
16/09/2015
Approval date [1] 298794 0
16/12/2015
Ethics approval number [1] 298794 0
2015001477

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78242 0
Dr Ben Mitchell
Address 78242 0
Primary Care Clinical Unit
School of Medicine
The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 78242 0
Australia
Phone 78242 0
+61 401 230 770
Fax 78242 0
Email 78242 0
[email protected]
Contact person for public queries
Name 78243 0
Ben Mitchell
Address 78243 0
Primary Care Clinical Unit
School of Medicine
The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 78243 0
Australia
Phone 78243 0
+61 401 230 770
Fax 78243 0
Email 78243 0
[email protected]
Contact person for scientific queries
Name 78244 0
Ben Mitchell
Address 78244 0
Primary Care Clinical Unit
School of Medicine
The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 78244 0
Australia
Phone 78244 0
+61 401 230 770
Fax 78244 0
Email 78244 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.