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Trial registered on ANZCTR


Registration number
ACTRN12620001345976
Ethics application status
Approved
Date submitted
15/10/2020
Date registered
14/12/2020
Date last updated
14/12/2020
Date data sharing statement initially provided
14/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility trial of a pharmacist-led, personalised intervention targeting the incidence of reliever reliance and overuse in individuals with asthma.
Scientific title
Feasibility trial of a pharmacist-led, personalised intervention targeting the incidence of reliever reliance and overuse in individuals with asthma.
Secondary ID [1] 302504 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 319366 0
Condition category
Condition code
Respiratory 317328 317328 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-randomised, before-after, study. The first 30 participants at each pharmacy will be allocated to control, the following 30 participants will receive the intervention.

The intervention will include three components:
1. Delivery of targeted, standardised information, based on responses to the SABA reliance questionnaire (SRQ). This will be administered online via a weblink while the participant is at the pharmacy;
2. Personalised discussion between the pharmacist and participant based on the specific responses to the study questionnaires (conducted by the pharmacist after the online component) and
3. Referral to general practitioner (GP) for those at risk of SABA overuse.

The standardised information helps patients understand what their SRQ responses might mean for them. The aim of this information is to raise awareness of the problem of SABA overuse and provides advice about the correct use of SABA inhalers. This information will be provided directly to the patient on their personal device.

To complement the standardised messages, the pharmacist will have an in-person, brief discussion (expected to be less than 5 minutes) with the participant regarding their responses to the SRQ. The SRQ will provide the participant with a score between 4 and 20. A score of 12 or more indicates the participant holds beliefs that may lead them to over rely on SABA. For these participants, the pharmacist will give behaviour-change messages verbally along with written information to shift beliefs, based on the specific responses to each statement in the SRQ. For participants with scores of less than 12 on the SRQ, the pharmacists will provide messages that reinforce and strengthen the current beliefs about SABA.

The standardised information and information provided by the pharmacist has been designed specifically for the study, based on previous work conducted by the research group.

Finally, all participants who indicate they are not using a preventer or report they are using SABA more than twice a week will be categorised as at risk of SABA overuse and will be referred to their GP. Pharmacists will also discuss this with the participant and urge the patient to have a discussion with their GP about their answers to the questionnaire and potential for preventer treatment.

The project coordinator will shadow the pharmacist in 10% of the sample (with participant permission) to check for intervention fidelity.
Intervention code [1] 318794 0
Behaviour
Comparator / control treatment
Control group will receive usual care from their community pharmacy. This will involve provision of standardised educational material on asthma, known as an 'asthma self care fact card'. This is a readily available resource in New Zealand community pharmacies provided by the Pharmaceutical Society of New Zealand (https://www.psnz.org.nz). This will be provided to all control participants. The pharmacist may or may not discuss their reliever use with the participant (not prompted by study).
Control group
Active

Outcomes
Primary outcome [1] 325369 0
Recruitment and retention rates of participants in control and intervention groups. Recruitment and retention rates will be estimated through recording the number of participants invited to participate in the intervention by the pharmacist, number of participants who view the study URL but do not enter the study, number of participants recruited online and via the pharmacist and number of participants retained at the 30 days and 90 days follow-up. Reasons for exclusion will also be recorded. These outcomes will be analysed by accessing the survey website analytics.
Timepoint [1] 325369 0
90 days post-intervention
Primary outcome [2] 325370 0
The appropriateness of the outcome measures pre- and post-intervention which will be assessed by the number of completed questionnaires and proportion of participants with complete inhaler dispensing data.
Timepoint [2] 325370 0
90 days post-intervention
Primary outcome [3] 325371 0
Degree of participant acceptability of the intervention, measured using a study specific questionnaire and incorporating time to complete questionnaires.
Timepoint [3] 325371 0
immediately after the intervention
Secondary outcome [1] 387690 0
Degree of pharmacist acceptability of the intervention measured using a study specific questionnaire and semi-structured interviews and incorporating time to provide intervention.
Timepoint [1] 387690 0
Completion of study recruitment (after last intervention patient is enrolled)
Secondary outcome [2] 387691 0
Changes in beliefs about SABA, measured by the SRQ
Timepoint [2] 387691 0
immediately after the intervention and at 30 and 90 days post-intervention
Secondary outcome [3] 387692 0
Changes in dispensing rates in SABA use measured using data-linkage to pharmacy dispensing records.
Timepoint [3] 387692 0
90 days post-intervention
Secondary outcome [4] 387693 0
Self-reported asthma-related GP visits between the intervention and control group in participants deemed high-risk of SABA overreliance measured using self-report on study-specific questionnaire
Timepoint [4] 387693 0
30 and 90 days post-intervention

Eligibility
Key inclusion criteria
Individuals presenting to one of the two enrolled community pharmacies will be eligible to participate in the study if they meet the following eligibility criteria:
- Aged 18 years or over
- Prescribed a short acting beta agonist (SABA) as a ‘reliever’ for their asthma symptoms.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will not be eligible to participate if they are using a SABA for a reason other than asthma (e.g. viral respiratory infection, exercise-induced asthma), do not manage their own medicines or anticipate changes to their medicines within the next 90 days (i.e. are following a step up/down medication management approach).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a before-and-after study in which the control group will be recruited followed by the intervention group. This design was chosen to minimise the effect of the intervention provided by the pharmacist crossing over to the control group.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to evaluate feasibility and acceptability for quantitative data; thematic analysis using a general inductive approach will be used for qualitative data. Changes in beliefs and inhaler use between the groups will be analysed using an independent samples t-test. A generalized linear mixed model will be used to determine the effect of patient/pharmacy characteristics on measured outcomes.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 23051 0
New Zealand
State/province [1] 23051 0
Auckland

Funding & Sponsors
Funding source category [1] 306933 0
University
Name [1] 306933 0
University of Auckland Faculty Research Development Fund
Address [1] 306933 0
Faculty of Medical and Health Sciences, University of Auckland
85 ParkRd,
Grafton
Auckland, 1023
New Zealand
Country [1] 306933 0
New Zealand
Primary sponsor type
Individual
Name
Dr Amy Chan
Address
Faculty of Medical and Health Sciences, University of Auckland
85 ParkRd,
Grafton
Auckland, 1023

Country
New Zealand
Secondary sponsor category [1] 307495 0
None
Name [1] 307495 0
None
Address [1] 307495 0
None
Country [1] 307495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307079 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 307079 0
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 307079 0
New Zealand
Date submitted for ethics approval [1] 307079 0
Approval date [1] 307079 0
18/08/2020
Ethics approval number [1] 307079 0
20/NTB/153

Summary
Brief summary
In patients with asthma, reliever over-reliance and overuse is common. A recently developed, brief, online intervention has been shown to identify and change patient beliefs driving inappropriate reliever use in an online sample. There is a need to trial this intervention in in the community setting and test the effect on beliefs about relievers and actual reliever use.

Objective
To investigate the effect, feasibility and acceptability of a brief community pharmacy-delivered behaviour change intervention, on individual’s beliefs about short-acting beta2 agonist (SABA) and on SABA use in patients with asthma.

Methods
This is a non-randomized, before- and after- study of individuals aged 18 years and older, prescribed a SABA for their asthma symptoms, attending one of two enrolled community pharmacies in Auckland, New Zealand. We aim to recruit 120 participants.

At enrolment, all participants will complete the 4-item SABA Reliance Questionnaire (SRQ), Asthma Control Test and Medication Adherence Report Scale via an online survey system. Control participants will receive usual care from their community pharmacy. Intervention participants will receive a brief, pragmatic intervention aimed to shift any misplaced beliefs about SABA. This includes delivery of targeted, standardized information, based on responses to the SRQ, a personalized discussion between the pharmacist and participant based on the specific responses to the questionnaires and referral to the general practitioner for those at risk of SABA overuse.

Feasibility will be evaluated through participant recruitment and retention rates, intervention fidelity, the appropriateness and procedures of outcome measures pre- and post-intervention, and acceptability by obtaining feedback from participants (both patients and pharmacists) on the intervention
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105958 0
Dr Amy Chan
Address 105958 0
School of Pharmacy, Level 3, Building 505,
The University of Auckland
85 Park Rd,
Grafton, 1023
Auckland
Country 105958 0
New Zealand
Phone 105958 0
+6493737599
Fax 105958 0
Email 105958 0
a.chan@auckland.ac.nz
Contact person for public queries
Name 105959 0
Dr Holly Foot
Address 105959 0
School of Pharmacy, Level 3, Building 505,
The University of Auckland
85 Park Rd,
Grafton, 1023
Auckland
Country 105959 0
New Zealand
Phone 105959 0
+6493737599
Fax 105959 0
Email 105959 0
holly.foot@auckland.ac.nz
Contact person for scientific queries
Name 105960 0
Dr Holly Foot
Address 105960 0
School of Pharmacy, Level 3, Building 505,
The University of Auckland
85 Park Rd,
Grafton, 1023
Auckland
Country 105960 0
New Zealand
Phone 105960 0
+6493737599
Fax 105960 0
Email 105960 0
holly.foot@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9445 0
Study protocol
Citation [1] 9445 0
Link [1] 9445 0
Email [1] 9445 0
holly.foot@auckland.ac.nz
Other [1] 9445 0
Attachment [1] 9445 0
Type [2] 9446 0
Informed consent form
Citation [2] 9446 0
Link [2] 9446 0
Email [2] 9446 0
holly.foot@auckland.ac.nz
Other [2] 9446 0
Attachment [2] 9446 0
Type [3] 9447 0
Ethical approval
Citation [3] 9447 0
Link [3] 9447 0
Email [3] 9447 0
holly.foot@auckland.ac.nz
Other [3] 9447 0
Attachment [3] 9447 0
Summary results
No Results