ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1203-4568

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Asthma

Condition category

Condition code

Respiratory

Asthma

Public Health

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]

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]

Attended the clinic for a planned asthma care review as recorded in the patients' medical records.

Timepoint [1]

3 months post-intervention.

Secondary outcome [1]

Obtained a current asthma action plan as recorded in the patients' medical records.

Timepoint [1]

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?

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]

4014 - Banyo

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

RACGP/IPN Medical Centres Research Grant

Address [1]

RACGP Foundation
100 Wellington Parade
East Melbourne VIC 3002

Country [1]

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]

Individual

Name [1]

Dr John Carter

Address [1]

Banyo Clinic
183 Tufnell Rd
Banyo QLD 4014

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Medical Research Ethics Committee

Ethics committee address [1]

UQ Research & Innovation
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/09/2015

Approval date [1]

16/12/2015

Ethics approval number [1]

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

Dr Ben Mitchell

Address

Primary Care Clinical Unit
School of Medicine
The University of Queensland
288 Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 401 230 770

Fax

b.mitchell@uq.edu.au

Contact person for public queries

Name

Ben Mitchell

Address

Primary Care Clinical Unit
School of Medicine
The University of Queensland
288 Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 401 230 770

Fax

b.mitchell@uq.edu.au

Contact person for scientific queries

Name

Ben Mitchell

Address

Primary Care Clinical Unit
School of Medicine
The University of Queensland
288 Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 401 230 770

Fax

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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Documents added automatically

No additional documents have been identified.

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