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
UQ Research & Innovation
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia QLD 4072
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
We know that asthma is a common but serious illness that causes deaths in otherwise healthy people, including young people and children. While asthma can’t be cured, it can be managed but this does require regular review of symptoms and medications, particularly because the disease can vary in severity over time, with different triggers affecting this. One strategy to improve asthma management is an asthma action plan. This is a written document that outlines how a patient’s asthma can be managed. It is individualized for each patient, and for different levels of asthma severity. It has been shown that having an asthma action plan reduces asthma mortality, yet many patients with asthma do not have a current up-to-date action plan. Part of the reason for this is that many patients with asthma only attend when they are unwell and do not attend for a planned visit to review their asthma care.

Our aim is to see if a simple short messenger service (SMS) sent by the GP clinic (Banyo Clinic) increases the number of patients who attend for a planned asthma review, and as such get a current asthma action plan as part of this. To do this, we plan to design and use a computer program to search the existing general practice database and identify those patients with asthma who are eligible. Performing such a search and identification is a usual part of good practice care and clinicians regularly carry out similar audits of their databases. In this project, we additionally wish to send a SMS message to half of the population identified, inviting them to book an appointment for an asthma review. The other half of the population won’t receive an SMS and therefore will receive usual care. After two months, we will send a follow up reminder SMS to those who haven’t attended for an asthma visit with the same SMS reminder.

After data collection, we will analyse the data to see if the group who received the SMS attended at a different proportion to the control group for asthma visits and supply of action plans. Our hypothesis is that, compared to usual care in the control group, receiving an automated SMS reminder prompting patients to attend for an asthma management review will:
1: Increase the attendance at the clinic for a planned asthma review
2: Increase the proportion of patients with asthma management plans

The population target will be active patients with asthma who have attend the Banyo Clinic at least twice in the preceding two years who have a mobile phone number attached to their file. Eligible participants will be defined as those who have asthma in their active past history. Participants will be identified from the clinic's data base and recruited by mail from the clinic. It is estimated that there will be approximately 300 eligible people in both the control group and the intervention groups. The participants will be randomized by computer to either the intervention (SMS receiving group) or the control (care as usual) group.
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
b.mitchell@uq.edu.au
Contact person for public queries
Name 78243 0
Dr 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
b.mitchell@uq.edu.au
Contact person for scientific queries
Name 78244 0
Dr 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
b.mitchell@uq.edu.au

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

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