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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 information initially 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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 290683 0
Level 3, 486 Pacific Highway
St Leonards NSW 2065
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
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
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
This study aims to trial an intensive telephone counselling service for adults with poorly controlled asthma. We aim to improve asthma control and therefore reduce asthma flare-ups, hospitalisations and absenteeism.
Trial website
http://www.asthmaaustralia.org.au/Participate_in_asthma_research.aspx
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
A/Prof 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
A/Prof 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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary
PROJECT REPORT PATIENT SUPPORT PILOT
ASTHMA FOUNDATION NSW AND SYDNEY UNIVERSITY
Final Report, September, 2017

Background
Asthma affects 10% of Australians, and the burden of asthma on the health system is well documented. A key aspect of asthma management in adults is provision of information, skills and tools for self-management including information and support to maximise adherence. Research indicates that poor adherence is a significant risk factor for asthma morbidity and mortality [1]. Individuals’ beliefs about their condition and their medications are key predictors of their asthma control and medication adherence behaviour. These beliefs can be modified with tailored interventions with improved adherence to treatment [2].

Asthma Foundation NSW (AF NSW) recently extended their telephone service—The Asthma Information Line—to trial a new structured, consumer-centred approach applying beliefs-based behaviour change interventions to support improved self-management and thus adherence and asthma control. This project aimed to develop, test and evaluate a telephone patient support and education program run by AF NSW. In addition the project aimed to examine participants’ perceptions of study resources and telephone-based counselling, elicit participants’ level of satisfaction and personal achievements and gain staff feedback on study resources and areas for future improvement. The study hypothesis was that the intervention would lead to improved asthma control and improved medication adherence for people with poorly controlled asthma.

Methods
A project working group was set up including the Education Manager AFNSW and AF staff (responsible for participant recruitment and information provision), Atlantis Healthcare (development of educational component) and the University of Sydney (research expertise, training, advice and input regarding research procedures, delivery of the intervention and recruitment strategies; record keeping and data management).

Study Design
The study was conducted in two phases. Phase 1 was a randomised controlled trial. Based on the volume of previous calls to AF NSW information line, it was expected that 180 participants could be enrolled into this study (90 intervention and 90 control).
Phase 2 was qualitative, involving exit interviews with participants and AF staff.

Phase 1
Recruitment
Potential participants were identified in one of three ways:
1. After ringing the AF NSW patient Infoline and receiving the usual service, potential participants were asked if they would like to participate in the project (this was to avoid coercion).
2. Visitors to the AF NSW web site could read information about the study and click a link indicating their willingness to be contacted about the study.
3. AF NSW social media and posters also directed people to the web site


Screening for Eligibility
The following screening questions/scales were asked or conducted with potential participants

• Asthma Control Test (if > 19 ineligible)
• Have you received a medical diagnosis of asthma from a health care professional?
• Do you have COPD? (If yes – ineligible)
• Are you prescribed a preventer inhaler to help control your asthma?
• Over a 7-day period, how many puffs of your preventer are prescribed? There are many reasons why people decide not to take their preventer inhaler as prescribed. In an average week how many puffs do you take?

Consent was obtained in one of the following ways:
• verbally (audio recorded by the Infoline operator)
• written
o signed consent form
o tick box in email

Allocation and Intervention
Participants were randomly allocated into Control or Intervention groups.
For the Control group each participant received a single phone call from AFNSW Infoline as per the usual service. For the Intervention group, and based on a literature review and previous research evidence, participants received:
o 6 intensive, structured, telephone-based education and support calls from trained AF NSW Infoline staff. These calls were individually tailored, using baseline information from participants regarding their illness perceptions using BIPQ (Brief Illness Perception Questionnaire). Call guides were utilised for each area explored in the BIPQ e.g. necessity of treatment and medication beliefs, as well as other issues such as practical difficulties of using an inhaler device.
o discussions were supported by purpose designed resources including a goal setting card; Live Well with Asthma DVD; “Things to ask and tell your Doctor” brochure and fridge magnet.
o the individualised program included a goal setting component to assist participants to identify personally relevant asthma-related problems and set one or two goals and develop strategies to achieve the goals (goal setting card provided to participants). See Appendix for goals card.
o option to receive SMS reminders



Data collection and analysis
Study instruments
A purpose designed study questionnaire was developed combining existing validated scales including the Asthma Control Test (ACT) [3]; Medication Adherence Report Scale for Asthma (MARSA10) [4], Medication Beliefs [5], and the Brief Illness Perception Questionnaire (BIPQ) [6]. See Appendix 1_Measurement Calls.

Additional data were collected regarding participants’ goals and strategies set and achieved; service use [hospitalisations; ED attendance]; oral steroid use and absenteeism.

The measurement calls utilising the above questionnaire were conducted verbally by an independent University of Sydney researcher, and the questionnaire scores were recorded digitally on a password-protected computer software program. Measurement calls were conducted at baseline (Measurement call 0), and then at 5 weeks (M1), 11 weeks (M2), 6 months (M3) and 12 months (M4)

Outcome measures
Change in scores for ACT, MARSA10, Medication Beliefs, and BIPQ comparing Intervention and Control groups at each time point were analysed using SPSS version 22[repeated measures ANOVA; 5% significance level]

Data regarding goals, hospitalisations, health service use, oral steroid use and absenteeism were analysed descriptively.

Phase 2
Following completion of the intervention and evaluation via measurement calls, telephone interviews were conducted with Intervention participants using a second purpose-designed questionnaire [Appendix 2] to examine participants’ perceptions of study purpose, satisfaction and personal achievements. These were audio recorded for transcription and analysis. Thematic analysis of the interviews was undertaken. Interviews were also conducted with AF NSW staff involved in delivering the service to understand facilitators and barriers to delivering the service.

Ethics
Ethics approval was received from the University of Sydney [HREC 2014-938]

Results
Recruitment
The first participant was recruited for this study in March 2015. However recruitment presented some unexpected challenges. A number of screened participants (n=51) were ineligible for the study because either their asthma control score was too high, or they reported good adherence to their preventer medication.

In response to slow recruitment, a modification application involving additional recruitment avenues was submitted and approved by the Human Ethics Committee University of Sydney in June 2015. The original project officer left the project in October 2015, and a new project officer commenced in late November 2015. Asthma Foundation NSW handled data evaluation tasks during October 2015. At this stage, a number of pharmacies were visited to promote the project. In addition, recruitment posters were put up at neighbourhood centres in Central Sydney and the Lower North Shore. A further project modification application to update recruitment tools i.e. poster and flyer was submitted and approved by the Human Ethics Committee in February 2016. Following this, GPs who previously worked with Asthma Foundation projects were identified and new project material posted to them. The study was also promoted through the Sydney University Research newsletter in early February 2016. Despite these efforts recruitment continued to be slow.

Participant demographics
In total 30 adults were consented to participate in the study; 19 were randomised to Intervention and 11 to Control groups. Of these, two people withdrew and two were lost to follow up. Seventy three percent of participants were female and the average age was 42.7 years. With regard to their asthma status, 23% developed asthma in infancy, 30% as a child, 10% in teenage years and 33% as an adult.
Participant demographics (intention to treat) are detailed in Table 1.

Table 1 Participant demographics

Gender Males 27%
Age (mean) 42.7 years
range: 18-79 years
Education University 53%
TAFE 17%
High School 30%
Employment
status Full time 40%
Part time 30%
Retired 10%
Student 10%
Baseline
ACT (mean) 11.7


Health service use
There were no significant improvements over time (p > 0.05) between intervention and control groups with regard to presentations to emergency, hospital admissions, GP and specialist presentations, oral steroid use or absenteeism.

Goal setting
Of the 19 intervention participants, 16 completed the 12-month evaluation call. Of these, five participants indicated they had achieved their goal. Goals set included taking preventer, being more regular with medications, to get on lower dose of medication, to always carry inhaler and make sure to notify family in the event of an attack, and to have a plan.
“I hated using the whole preventer thing. But I was more or less convinced that it’s required…just bloody take it!” (P1)
“having more of an understanding about my asthma and not just being reactive, but trying to be more preventative, yeah except for the flares that occur I’d say I have been quite successful with a plan in place.”(P11)

Phase 1
Regarding changes in outcome measures over the 12-month study period, there were no statistically significant differences between intervention and control groups except for MARS baseline to M1 and M2 where medication adherence improved significantly for the intervention group compared to the control group (p <0.05);
Medication beliefs (Necessity) improved significantly from baseline to M1, M2; and
for ACT M2-M3 change was significant between intervention and control groups (p=0.02)

Phase 2 Qualitative Interviews
Fourteen participants consented to an exit interview. The emerging overarching themes based on participants’ perceptions of the telephone counselling service, were service provision; participant behaviour and quality of life.

Service provision
Participants found the six-week program to be convenient and accessible, and welcomed the time set aside to focus on their asthma.
“conversations were at a planned time and didn’t interfere with things and were effective and informative” (female 36 years)

Participants particularly appreciated the support of the information line staff, noting how they “normalised” the experience of having asthma, reassured them, and kept them on track
“Having M quite frequently being able to normalise what was going on for me so that I felt oh god I’m not the only person in the world who’s thinking, feeling or experiencing this. That was really important” (female 40 years)

“Someone I could talk to who was a third party. Who wasn’t involved in my life was a big help” (female 34 years)

Participant behaviour
The interviews highlighted behaviours of people with poorly controlled asthma. After the program, participants reported improved knowledge; willingness to use a preventer; and improved confidence in managing and controlling asthma, including goals set and achieved.
“as a result of the program I’m a lot more informed and educated about my asthma and I also found I’m behaving a lot better, like I’m taking my preventer which I didn’t used to”
(female 37 years)
“it helped with bad habits… but also reinforced good habits like making sure you use your medication and be more aware and mindful of your condition” (female 40 years)

Quality of Life
Analysis of the interviews also revealed how poorly controlled asthma can affect quality of life of participants and also the whole family:
“I don’t basically sleep for weeks” (female 53 years)

“At the end of winter the bushfire burning… I get severely ill every year because of it. Can’t open the window in my bedroom because of it you know… because of the wind I couldn’t even go out the door” (female 58 years)

“as a kid, my parents were thinking of moving away from the South Coast cause I just couldn’t breathe when the wattle was out” (male 64 years)

Information Line Staff perceptions
Information Line staff felt that this program was an opportunity for participants to stop and take stock of their asthma:

“most people had not really prioritised their asthma. So making a conscious decision to do that was really good…people were appreciative and keen to put it at the forefront and see the benefits of that”

Project outputs
The results of Phase 2 were presented as a poster at TSANZ 2017 Conference. [Appendix 3]

Discussion and Conclusion
This was a high intensity, low reach intervention program aimed at motivating people with poorly controlled asthma to improve their asthma control and quality of life. Key findings included important insights into the behaviour of people with poorly controlled asthma from the post-intervention interviews.

Unfortunately, there were unanticipated challenges with recruitment, which meant that the sample size was not sufficient to undertake robust and interpretable statistical analysis. Reasons for the recruitment issues may be that there are a number of asthma “projects” currently crowding the research space; and that the parameters for poorly controlled asthma were not understood well enough by potential participants.

There appear to be few previous published reports of telephone- based asthma counselling for adult patients. A randomised Australian study of 71 adults with previous hospital admissions for asthma who were telephoned six times over six months by asthma educators found a reduction in re-admissions and an increase in written action plan ownership [7]. Whilst few objective measures yielded statistically significant results in the current study, it was pleasing to see that initially medication adherence improved significantly for the intervention group compared to the control group paralleled by a significant increase in participants perceiving the necessity for preventer, and accompanied by an improvement in asthma control. However, as previously noted, due to sample size these results are not generalisable. The reluctance of asthma patients to use a preventer is well known from the literature [8]. The qualitative responses echo the participants’ previous reluctance to use a preventer, but an acceptance of the necessity with appropriate education and support.

In conclusion, this research adds to the knowledge of how people with poorly controlled asthma view their asthma and the challenges of providing support.

References:
1. Eakin MN, Rand CS. Improving patient adherence with asthma self-management practices: what works? Ann Allergy Asthma Immunol 2012; 109 (2): 90-92
2. Petrie KJ, Perry K, Broadbent E, et al. A text message programme designed to modify patients’ illness and treatment beliefs improves self-reported adherence to asthma preventer medication. Br J Health Psychol 2012; 17:74–84.
3. Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65.
4. Mora PA, Berkowitz A, Contrada RJ, Wisnivesky J, Horne R, Leventhal H, Halm EA. Factor structure and longitudinal invariance of the Medical Adherence Report Scale-Asthma. Psychol Health. 2011 Jun; 26(6): 713-27. doi: 10.1080/08870446.2010.490585.
5. Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health.1999;14:1–24.
6. Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res 2006; 60 (6): 631-7
7. Donald KJ, McBurney H, Teichtahl H, Irving L. A pilot study of telephone based asthma management. Aust fam Physician 2008; 37 (3): 170-3.
8. Thomas M, Bateman E. Asthma attacks: how can we reduce the risks? NPJ Prim Care Respir Med 2015; 25: 14105.