Trial Review

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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] 307238 0
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) 326428 0
Condition category
Condition code
Public Health 323708 323708 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
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] 323681 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331455 0
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] 331455 0
During the interview period.
Secondary outcome [1] 409956 0
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] 409956 0
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?
No
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
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 24786 0
New Zealand
State/province [1] 24786 0
Auckland

Funding & Sponsors
Funding source category [1] 311503 0
University
Name [1] 311503 0
The University of Auckland
Country [1] 311503 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] 312952 0
None
Name [1] 312952 0
Address [1] 312952 0
Country [1] 312952 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310965 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 310965 0
11 Symonds Street, Auckland CBD, Auckland, 1010
Ethics committee country [1] 310965 0
New Zealand
Date submitted for ethics approval [1] 310965 0
23/05/2022
Approval date [1] 310965 0
Ethics approval number [1] 310965 0

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 119518 0
Prof Keith Petrie
Address 119518 0
University of Auckland, Psychological Medicine Department, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023
Country 119518 0
New Zealand
Phone 119518 0
+64 211117222
Fax 119518 0
Email 119518 0
[email protected]
Contact person for public queries
Name 119519 0
Krystal Wright
Address 119519 0
University of Auckland, Psychological Medicine Department, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023
Country 119519 0
New Zealand
Phone 119519 0
+64 212665801
Fax 119519 0
Email 119519 0
[email protected]
Contact person for scientific queries
Name 119520 0
Krystal Wright
Address 119520 0
University of Auckland, Psychological Medicine Department, Building 507, Floor 3, 30 Park Road, Grafton, Auckland, 1023
Country 119520 0
New Zealand
Phone 119520 0
+64 2126685801
Fax 119520 0
Email 119520 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
16187Study protocol  [email protected]
16188Ethical approval  [email protected]
16189Informed consent form  [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.