ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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Trial registered on ANZCTR

Registration number

ACTRN12622000790741p

Ethics application status

Submitted, not yet approved

Date submitted

25/05/2022

Date registered

3/06/2022

Date last updated

3/06/2022

Date data sharing statement initially provided

3/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Cognitive Interviews to develop the Anticipated Adherence Index (AAI).

Scientific title

Cognitive Interviews to develop the Anticipated Adherence Index (AAI).

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1278-5304

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Any health condition which is treated by long-term medication (one year or more)

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

Cognitive interviews will be conducted with 25 participants, in order to gain feedback about the newly developed Anticipated Adherence Index (AAI). This novel scale aims to measure adherence to medication, prior to medication initiation.

The cognitive interviews will be in-person at the Auckland University Clinical Research Centre. Each participant will be asked to complete one, 45 minute appointment. These interviews will be conducted by the student researcher.

The 'think aloud' cognitive interviewing procedure developed by Willis (2007) will be utilised during the interview. In this protocol, participants are provided with a training question to introduce them to the think-aloud protocol. This protocol asks participants to verbally respond to each item, and also verbalise their thought processes that led to their response. An audio recording of the participant's verbal think-aloud stream will be taken to capture the nuances in each subjects answer. These will be transcribed following each interview. Thematic analysis will be utilised to identify the main themes related to each item. This information will be used to adapt the Anticipated Adherence Index with the wider research team

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Qualitative responses to the Anticipated Adherence Index (AAI) items will be collected by using one-on-one, face 45-minute interviews. These interviews will be utilising the Cognitive Interviewing protocol. These interviews are semi-structured, and will be audio-recorded.

Timepoint [1]

During the interview period.

Secondary outcome [1]

Preliminary content validity of the AAI will be determined, by assessing whether the intended content measured in each item, was relevant to the theme output of the thematic analysis.

For example, if an items main focus is self-efficacy within the AAI, then the qualitative output will be analysed to determine if self-efficacy was a theme among the responses to that item.

Timepoint [1]

Cumulative responses will be assessed at the conclusion of the interview period.

Eligibility

Key inclusion criteria

Participants must be 18 years of age or over, currently prescribed a long-term medication for one year or more, able to fill out the questionnaires, willing to participate, and fluent in English language.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Individuals prescribed medication for over 1 year which is on a 'take as needed' basis such as paracetamol or ibuprofen.

Study design

Purpose

Psychosocial

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The Qualitative Data from the interviews will be analysed using a thematic analysis approach. This analysis requires the following six stages.
1. Familiarising with the dataset
2. Coding
3. Generating initial themes
4. Developing and reviewing themes
5. Refining, defining, and naming themes
6. Writing up

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

20/06/2022

Actual

Date of last participant enrolment

Anticipated

1/08/2022

Actual

Date of last data collection

Anticipated

1/08/2022

Actual

Sample size

Target

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 Road, 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

Submitted, not yet approved

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]

23/05/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The proposed study is a health research study. We are currently developing a new scale (The Anticipated Adherence Index) to measure adherence before people start to take their medication. This measure aims to identify those who may possibly struggle with medication adherence. To make sure each of the items are understood and interpreted as expected, we want to run in-person cognitive interviews with 25 participants who have been taking a long-term medication (1 year or more).

This study consists of a cross-sectional design with 25 minimum participants. Participants will include patients that have been on a long-term prescribed medication or a year or more. These patients will participate in a cognitive interview about the newly developed Anticipated Adherence Index. 

The 25 participants will be recruited by advertising via facebook community pages, community message boards and community email lists. A poster with a QR code, and researcher contact information will be used. The QR code and researcher will direct potential participants to a qualtrics link which assesses eligibility by ensuring that individuals meet inclusion criteria. 

The research team will then send an email to those who register their interest in the study and provide them with a full participant information sheet and consent form. At this stage, these individuals will have the option to book an appointment with the student researcher to conduct the interview. Potential participants will also have an option to ask the researcher any questions. 

The cognitive interviews will be conducted in person at the University of Auckland Clinical Research Centre. Participants will then be notified of their appointment confirmation and meet the researcher at the agreed-upon location and time. To ensure consistency, the same researcher will be conducting all cognitive interviews. 

The 'think aloud' cognitive interviewing procedure developed by Willis (2007) will be utilised during the interview. In this protocol, participants are provided with a training question to introduce them to the think-aloud protocol. This protocol asks participants to verbally respond to each item, and also verbalise their thought processes that led to their response.  An audio recording of the participant's verbal think-aloud stream will be taken to capture the nuances in each subjects answer. These will be transcribed following each interview. Thematic analysis will be utilised to identify the main themes related to each item. This information will be used to adapt the Anticipated Adherence Index with the wider research team.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Keith Petrie

Address

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

Country

New Zealand

Phone

+64 211117222

Fax

kj.petrie@auckland.ac.nz

Contact person for public queries

Name

Krystal Wright

Address

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

Country

New Zealand

Phone

+64 212665801

Fax

kwri715@aucklanduni.ac.nz

Contact person for scientific queries

Name

Krystal Wright

Address

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

Country

New Zealand

Phone

+64 2126685801

Fax

kwri715@aucklanduni.ac.nz

Data sharing statement

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

No/undecided IPD sharing reason/comment

Given the qualitative data, and small sample size, no IPD will be shared to ensure confidentiality of all participants.

What supporting documents are/will be available?

Doc. No.	Type	Email
16187	Study protocol	kwri715@aucklanduni.ac.nz
16188	Ethical approval	kwri715@aucklanduni.ac.nz
16189	Informed consent form	kwri715@aucklanduni.ac.nz

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

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