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Trial registered on ANZCTR


Registration number
ACTRN12615000142538
Ethics application status
Approved
Date submitted
4/02/2015
Date registered
16/02/2015
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a telephone counselling intervention for people with asthma.
Scientific title
In people with poorly controlled asthma, does a telephone patient education and support program when compared with a control group increase adherence to prescribed medication regimes and improve asthma control.
Secondary ID [1] 286102 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poorly controlled asthma 294103 0
Condition category
Condition code
Respiratory 294414 294414 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will receive 6 intensive telephone based education and support calls every 2 weeks from specially trained (Asthma Foundation NSW (AFNSW) InfoLine staff. Discussions will be supported by relevant AFNSW copyrighted resources, which may be hard copy by mail, web links or emailed resources. Telephone calls are expected to last between 5 and 10 minutes. The sessions will include completion of questionnaires that will be used to individualise the coaching received. Coaching may include asthma education, trigger identification and avoidance as well as adherence strategies and goal setting etc.
Intervention code [1] 291098 0
Lifestyle
Intervention code [2] 291099 0
Behaviour
Intervention code [3] 291148 0
Treatment: Other
Comparator / control treatment
Usual AFNSW service - Each participant will have a single phone call with the AFNSW InfoLine as per the usual service.
This service provides evidence based information and advice on asthma and answer any questions they might have. The length of call is dependent on the caller's needs.
Control group
Active

Outcomes
Primary outcome [1] 294207 0
Primary Outcome 1: Asthma Control Test
Timepoint [1] 294207 0
Timepoint: baseline, 4 weeks, 13 weeks, 6 and 12 months
Primary outcome [2] 294208 0
Primary Outcome 2: Medication Adherence Report Scale for Asthma
Timepoint [2] 294208 0
Timepoint: baseline, 4 weeks, 13 weeks, 6 and 12 months
Primary outcome [3] 294209 0
Primary Outcome 3: Brief Illness Perception Questionnaire
Timepoint [3] 294209 0
Timepoint: baseline, 4 weeks, 13 weeks, 6 and 12 months
Secondary outcome [1] 312768 0
Secondary Outcome 1: goals and strategies set and goal achievement.
Participants will be assisted to identify asthma-related problems of personal relevance and set one or two realistic goals and develop strategies to achieve the goals.
Timepoint [1] 312768 0
Timepoint: at baseline, 4 weeks, 13 weeks, 6 and 12 months
Secondary outcome [2] 312769 0
Secondary Outcome 2: hospitalisations.
Participants will be asked whether they had been admitted to hospital due to asthma since the previous call.
Timepoint [2] 312769 0
Timepoint: at baseline, 4 weeks, 13 weeks, 6 and 12 months
Secondary outcome [3] 312770 0
Secondary Outcome 3: emergency department attendance.
Participants will be asked whether they had presented to an emergency department due to asthma since the previous call.
Timepoint [3] 312770 0
Timepoint: at baseline, 4 weeks, 13 weeks, 6 and 12 months
Secondary outcome [4] 312771 0
Secondary Outcome 4: oral steroid use.
Participants will be asked whether they had taken oral steroids for an asthma exacerbation since the previous call.
Timepoint [4] 312771 0
Timepoint: at baseline, 4 weeks, 13 weeks, 6 and 12 months
Secondary outcome [5] 312772 0
Secondary Outcome 5: absenteeism.
Participants will be questioned whether they had been absent from work or school due to asthma since the previous call.
Timepoint [5] 312772 0
Timepoint: at baseline, 4 weeks, 13 weeks, 6 and 12 months
Secondary outcome [6] 312773 0
Secondary Outcome 6: qualitative evaluation.
Individual telephone interviews with some participants will be conducted exploring perceptions of the purpose of the program, satisfaction, personal achievements. These will be undertaken both with those who had positive outcomes and those without.
Timepoint [6] 312773 0
Timepoint: at baseline, 4 weeks, 13 weeks, 6 and 12 months

Eligibility
Key inclusion criteria
Adults (18+ years) with poorly controlled asthma.
The initial screening tool will be the validated Asthma Control Test (also known as the Asthma Score), a 5-item patient questionnaire that identifies those with poorly controlled asthma.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Has not previously received a diagnosis from a doctor of asthma
Has co-existing lung condition e.g. COPD
Is not currently prescribed an asthma preventer inhaler
Is adherent to preventer inhaler

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will have phoned the AFNSW Infoline service. Following the usual Infoline service the phone counsellor will inform the potential participant that AFNSW is conducting a study. Brief verbal information may then be provided regarding the study and if interested a four question eligibility screening will be asked. The four questions are: are you over 18 years of age? ; have you been diagnosed with asthma by a doctor? ; do you currently take an asthma preventer inhaler? ; have you been diagnosed with another lung condition?

If the potential participant is eligible and interested then their contact details will be collected and an email or letter will be sent containing the Patient Information Statement (PIS) and Patient Consent Form (PCF). A reminder follow up call will be made after one week.

Participants will be allocated to either intervention or control group by the Infoline service counsellor. The participant will not be told which group they are in.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will occur at the level of the telephone call. Each alternate call will be allocated to the intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative outcome data will be analysed using parametric and non-parametric statistical methods to determine any differences in outcome measures of the intervention compared to control groups.
Qualitative data from post-service participant and telephone counsellor interviews will be content analysed for emergent and anticipated themes, following transcription of audio recorded interviews.
Sample size: Based on a power calculation (alpha level= 0.05; 80% power), N =180 (90 intervention and 90 control)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2015
Actual
25/03/2015
Date of last participant enrolment
Anticipated
Actual
30/01/2016
Date of last data collection
Anticipated
Actual
21/11/2019
Sample size
Target
180
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290683 0
Charities/Societies/Foundations
Name [1] 290683 0
Asthma Foundation NSW
Country [1] 290683 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Pharmacy
Room N405, Building A15
The University of Sydney
NSW 2006 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 289377 0
Charities/Societies/Foundations
Name [1] 289377 0
Asthma Foundation NSW
Address [1] 289377 0
Level 3, 486 Pacific Highway
St Leonards NSW 2065
Country [1] 289377 0
Australia
Secondary sponsor category [2] 289378 0
Commercial sector/Industry
Name [2] 289378 0
Atlantis Healthcare
Address [2] 289378 0
7/112-118 Talavera Rd
Macquarie Park NSW 2113
Country [2] 289378 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292313 0
The University of Sydney Human Ethics Committee
Ethics committee address [1] 292313 0
Ethics committee country [1] 292313 0
Australia
Date submitted for ethics approval [1] 292313 0
Approval date [1] 292313 0
07/12/2014
Ethics approval number [1] 292313 0
2014/938

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

Contacts
Principal investigator
Name 54646 0
A/Prof Lorraine Smith
Address 54646 0
Room N405, Building A15
The University of Sydney
NSW 2006 AUSTRALIA
Country 54646 0
Australia
Phone 54646 0
+61 2 9036 7079
Fax 54646 0
Email 54646 0
lorraine.smith@sydney.edu.au
Contact person for public queries
Name 54647 0
Lorraine Smith
Address 54647 0
Room N405, Building A15
The University of Sydney
NSW 2006 AUSTRALIA
Country 54647 0
Australia
Phone 54647 0
+61 2 9036 7079
Fax 54647 0
Email 54647 0
lorraine.smith@sydney.edu.au
Contact person for scientific queries
Name 54648 0
Lorraine Smith
Address 54648 0
Room N405, Building A15
The University of Sydney
NSW 2006 AUSTRALIA
Country 54648 0
Australia
Phone 54648 0
+61 2 9036 7079
Fax 54648 0
Email 54648 0
lorraine.smith@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
needs to be discussed with all stakeholders


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.