ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

Early Detection / Screening

Comparator / control treatment

There is no control treatment as this is an observational study.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Initial survey measurement

Primary outcome [2]

Internal Consistency of the AAI determined by utilising Cronbach's Alpha

Timepoint [2]

Initial survey measurement

Primary outcome [3]

Predictive Validity

Timepoint [3]

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]

Test-retest (inter-rater) reliability of the Anticipated Adherence Index (AAI) using Cohen's Kappa

Timepoint [1]

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?

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Auckland

Address [1]

30 Park Avenue, Grafton, Auckland, 1023

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Auckland Health Research Ethics Committee

Ethics committee address [1]

11 Symonds Street, Auckland CBD, Auckland, 1010

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

20/06/2022

Approval date [1]

Ethics approval number [1]

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

Prof Keith Petrie

Address

The University of Auckland, Department of Psychological Medicine, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023

Country

New Zealand

Phone

+64 211117222

Fax

[email protected]

Contact person for public queries

Name

Krystal Wright

Address

The University of Auckland, Department of Psychological Medicine, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023

Country

New Zealand

Phone

+64 212665801

Fax

[email protected]

Contact person for scientific queries

Name

Krystal Wright

Address

The University of Auckland, Department of Psychological Medicine, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023

Country

New Zealand

Phone

+64 212665801

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
16340	Study protocol	[email protected]
16341	Informed consent form	[email protected]
16342	Ethical approval	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically