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Trial registered on ANZCTR


Registration number
ACTRN12622000848707p
Ethics application status
Not yet submitted
Date submitted
8/06/2022
Date registered
16/06/2022
Date last updated
16/06/2022
Date data sharing statement initially provided
16/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Initial validation of the Anticipated Adherence Index (AAI) via Community Pharmacies
Scientific title
Initial validation of the Anticipated Adherence Index (AAI) via Community Pharmacies
Secondary ID [1] 307314 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is related to study ACTRN12622000790741. Where the prior study aims to gather qualitative data, whereas, this study aims to gather quantitative data for the Anticipated Adherence Index (AAI).

Health condition
Health condition(s) or problem(s) studied:
Any health condition that has required a new or repeat prescription medication 326599 0
Condition category
Condition code
Public Health 323845 323845 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In order to understand adherence to medications, measurement is critical. Therefore, this study is the first to provide qualitative data in order to validate the newly developed Anticipated Adherence Index.

Potential participants will be given a small flyer about the study when they attend a pharmacy to collect a prescription. This flyer will be given to them by the pharmacist, and includes brief information about the study. Participants will be asked to complete the Anticipated Adherence Index via the online Qualtrics platform. This will take an average of 15 minutes for each participant to complete. Following completion of the survey, a window will pop up thanking them for their time, and reminding them about the follow-up measure in two-weeks time.

Two-weeks post initial measurement, participants will be asked to repeat the Anticipated Adherence Index (AAI) and the Brief Adherence Rating scale via Qualtrics. This will take around 15 minutes to complete & will enable researchers to determine whether adherence intentions prior to medication initiation was reflected by actual self-reported adherence during the two-week period. Following completion of the two-week follow-up, participants will be thanked for their time, and be told that they are now in the prize-draw for a $500 voucher.
Intervention code [1] 323759 0
Early Detection / Screening
Comparator / control treatment
There is no control treatment as this is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331654 0
The primary outcome will be responses to the Anticipated Adherence Index (AAI) which will allow for initial Principle Component Analysis (PCA), constrained Principle Component Analysis (PCA), Kaiser-Meyer Olkin Value and Barrett's Test of Sphericity to be utilised to identify and refine the factors within the AAI.
Timepoint [1] 331654 0
Initial survey measurement
Primary outcome [2] 331655 0
Internal Consistency of the AAI determined by utilising Cronbach's Alpha
Timepoint [2] 331655 0
Initial survey measurement
Primary outcome [3] 331656 0
Predictive Validity
Timepoint [3] 331656 0
Assessing correlation between initial survey measurement of the Anticipated Adherence Index (AAI), and two-week follow up measure of the Brief Adherence Rating Scale (BARS).
Secondary outcome [1] 410637 0
Test-retest (inter-rater) reliability of the Anticipated Adherence Index (AAI) using Cohen's Kappa
Timepoint [1] 410637 0
Comparing between initial Anticipated Adherence Index (AAI) measurement, with the two-week followup of the Anticipated Adherence Index (AAI).

Eligibility
Key inclusion criteria
Participants must be picking up a medication prescription for themselves that requires consistent adherence at a community pharmacy, be 18 years of age or over, and be fluent in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if prescribed medications are specified to take 'as needed', such as paracetamol or ibuprofen. This is given that such medications do not require consistent adherence.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
The AAI will be administered to a minimum of 140 individuals who have just picked up a prescribed medication from a community pharmacy. The response to the AAI is required for statistical analysis to refine the structure of the Anticipated Adherence Index (AAI). Analysis will include an initial Principal Component Analysis (PCA), constrained PCA, Kaiser-Meyer Olkin Value and Barrett’s Test of Sphericity. Internal consistency will be determined for each item and the entire scale using Cronbach’s Alpha. Predictive validity will be determined utilising a within sample t-test and assessing the correlation between the AAI pre-medication initiation and the BARS measure after two weeks. Test-retest reliability will also be ascertained by re-administering the AAI two weeks post initial measurement and utilising Cohens Kappa.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
1/10/2022
Actual
Date of last data collection
Anticipated
15/10/2022
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 24827 0
New Zealand
State/province [1] 24827 0
Auckland

Funding & Sponsors
Funding source category [1] 311607 0
University
Name [1] 311607 0
The University of Auckland
Country [1] 311607 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
30 Park Road, Grafton, Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 313040 0
None
Name [1] 313040 0
Address [1] 313040 0
Country [1] 313040 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311048 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 311048 0
11 Symonds Street, Auckland CBD, Auckland, 1010
Ethics committee country [1] 311048 0
New Zealand
Date submitted for ethics approval [1] 311048 0
20/06/2022
Approval date [1] 311048 0
Ethics approval number [1] 311048 0

Summary
Brief summary
Adherence to medications is integral for the management of both chronic and acute conditions, yet, in order to understand adherence behaviours, measurement is critical. Currently, there is no measure which allows for intentions to adhere to be assessed prior to medication initiation. Therefore, the Anticipated Adherence Index (AAI) is a newly developed scale in order to determine intentions to adhere prior to medication initiation. This study aims to provide initial validation via quantitative data.

This study is a cross-sectional design with a 2-week follow up to initially administer the newly developed Anticipated Adherence Index (AAI). Participants will be recruited from various community pharmacies in Auckland, and provided with a flyer by the pharmacist which will give a brief description of the study along with the QR code and link to complete the study.

In order to complete the study, participants will be required to read a participant information sheet, have the opportunity to ask the student researcher any questions via email, and fill out an eligibility questionnaire. If eligible, participants will be required to fill out brief demographic information, and complete the Anticipated Adherence Index (AAI). All of these steps will be completed via the Qualtrics platform.

Following their prescription period (or two-weeks post initial measurement), participants will be asked to fill out the Brief Adherence Rating Scale, and repeat the AAI measure via Qualtrics. The study outcomes will allow for further refinement of the AAI through statistical analysis and provide initial reliability and validity estimates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119814 0
Prof Keith Petrie
Address 119814 0
The University of Auckland, Department of Psychological Medicine, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023
Country 119814 0
New Zealand
Phone 119814 0
+64 211117222
Fax 119814 0
Email 119814 0
kj.petrie@auckland.ac.nz
Contact person for public queries
Name 119815 0
Miss Krystal Wright
Address 119815 0
The University of Auckland, Department of Psychological Medicine, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023
Country 119815 0
New Zealand
Phone 119815 0
+64 212665801
Fax 119815 0
Email 119815 0
kwri715@aucklanduni.ac.nz
Contact person for scientific queries
Name 119816 0
Miss Krystal Wright
Address 119816 0
The University of Auckland, Department of Psychological Medicine, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023
Country 119816 0
New Zealand
Phone 119816 0
+64 212665801
Fax 119816 0
Email 119816 0
kwri715@aucklanduni.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
IPD will not be available in order to assure confidentiality for our participants. This is a condition of our ethical approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16340Study protocol  kwri715@aucklanduni.ac.nz
16341Informed consent form  kwri715@aucklanduni.ac.nz
16342Ethical approval  kwri715@aucklanduni.ac.nz



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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