Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000646448
Ethics application status
Approved
Date submitted
27/09/2024
Date registered
18/06/2025
Date last updated
18/06/2025
Date data sharing statement initially provided
18/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study to evaluate the effect of Talking About Medicines: Video Guides for Healthy Hearts
Scientific title
Evaluation of animated educational videos on cardiovascular health literacy among Maori patients: a feasibility and acceptability study protocol
Secondary ID [1] 312758 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 334800 0
Condition category
Condition code
Cardiovascular 331358 331358 0 0
Coronary heart disease
Public Health 333284 333284 0 0
Health promotion/education
Public Health 333285 333285 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective, observational, mixed-methods study will be carried out at Te Whatu Ora Te Toka Tumai, Auckland City Hospital, New Zealand. The aim is to explore the practicality of implementing animated educational videos in a clinical setting, gather insights from patients and healthcare providers, and assess the intervention's impact on medication knowledge and attitudes.

The study will include 20 Maori inpatients aged 18 years or older who are admitted for acute coronary syndrome and have been initiated on new cardiovascular medications. The study will also include ten clinical staff members at the hospital who are directly involved in the care of patients diagnosed with acute coronary syndrome and who are involved in providing medication counselling.

Convenience sampling will be employed to recruit participants. Both patients and clinical staff who meet the inclusion criteria and express an interest in participating will receive a participant information sheet detailing the study objectives, procedures, potential risks, and benefits. Informed consent will be obtained from those who agree to take part.

Study procedure

Patients:
1. Pre-intervention assessment:
On consent, baseline demographic data such as age, gender, and current medication regimen will be collected. Patients will complete a survey assessing their initial knowledge, attitudes, and practices (KAP) regarding their new cardiovascular medications. This will serve as the baseline measurement.

2. Intervention:
Patients will be equipped with a tablet device and headphones and will receive instructions on how to access the videos. These videos will explain how cardiovascular medications work, their importance, and the benefits of adhering to the prescribed regimen. The research assistant will monitor patient engagement with the video content throughout this process, documenting any technical issues or obstacles encountered during engagement. Patients can choose which videos to watch from a set of 10 educational videos, each with a maximum duration of 2 minutes. Patients will be able to watch the videos as many times as they wish.

3. Post-intervention assessment:
After watching the videos, patients will complete a post-intervention assessment to assess changes in their knowledge, attitudes, and practices (KAP) concerning their cardiovascular medications. Additionally, the acceptability of the intervention will be evaluated using a modified version of the Theoretical Framework of Acceptability (TFA) questionnaire. The post-intervention survey will take approximately 5 minutes to complete.

The research assistant will then schedule in-depth interviews with patients at a convenient time for both parties. Interview questions will focus on:
• The relevance and usefulness of the video content.
• Patients' understanding of the information presented.
• Perceived cultural appropriateness and respectfulness of the content.
• Likelihood of recommending the videos to others.
• Any challenges faced during the intervention.

Patients will have the opportunity to ask questions and seek clarification throughout the study. They can invite family or support people to be present during sessions if desired. The session, including baseline data collection, video viewing, post-intervention assessment, and the in-depth interview, is expected to last approximately 30 minutes. After the study, patients will receive a QR code to access the videos on a website, where they can create an account and continue watching them.

Staff:
1. Pre-Intervention:
Clinical staff will be asked to watch at least three of the educational videos, selecting the videos they wish to view. Following this, they will complete an initial questionnaire, which will take approximately 5 minutes to complete. This questionnaire will assess their overall impressions, including the clarity and relevance of the content, ease of website navigation, and perceived usefulness of the videos in clinical practice.

Following the completion of this questionnaire, and where feasible, staff will be encouraged to implement the videos as part of their routine clinical care. To support this process, staff will receive a brief training session (approximately 10 minutes), which will cover how to access and navigate the video platform, as well as guidance on selecting appropriate patients for implementation. The videos may be used as a supplementary resource or, if deemed appropriate, as a replacement for existing patient education methods.

Staff will be responsible for confirming with each patient whether they have previously viewed the videos, to ensure that patients included in this phase are not the same individuals who participated in the intervention delivered by the research assistant.

Staff will then be asked to complete a second questionnaire, which will take approximately 5 minutes, evaluating the feasibility, acceptability, and appropriateness of integrating the videos into their practice. For staff who do not implement the videos, or who determine that they are not appropriate for their clinical context, their responses will reflect anticipated rather than actual implementation.

2. Post-implementation interviews:
Staff will participate in a 30-minute interview to discuss their experiences, provide feedback on whether the intervention was implemented in practice, and share their perspectives. Interview questions will cover:
- The practicality of integrating the videos into clinical practice.
- Observations on patient engagement and feedback.
- Challenges faced and potential improvements for future implementation.
- The perceived impact of the videos on patients' understanding and adherence.
Intervention code [1] 329289 0
Behaviour
Intervention code [2] 330626 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339121 0
To assess the feasibility of implementing the animated videos in a clinical setting amongst staff
Timepoint [1] 339121 0
Following video review or clinical implementation with a patient
Primary outcome [2] 340863 0
To assess the acceptability of the animated videos among Maori cardiovascular patients
Timepoint [2] 340863 0
Immediately after viewing the educational videos
Primary outcome [3] 340866 0
To assess the acceptability of the animated videos among clinical staff
Timepoint [3] 340866 0
Immediately after watching the videos
Secondary outcome [1] 438639 0
To assess the changes in knowledge of acute coronary syndrome medications among Maori cardiovascular patients
Timepoint [1] 438639 0
Before and immediately after watching the educational videos
Secondary outcome [2] 445369 0
To assess the changes in attitudes towards acute coronary syndrome medications among Maori cardiovascular patients
Timepoint [2] 445369 0
Immediately after watching the videos
Secondary outcome [3] 447979 0
To assess the relevance and clarity of the animated videos among Maori cardiovascular patients
Timepoint [3] 447979 0
Immediately after watching the videos
Secondary outcome [4] 447980 0
To assess the perceived relevance of the animated videos among clinical staff
Timepoint [4] 447980 0
Following video review or clinical implementation with a patient
Secondary outcome [5] 447981 0
To assess the cultural appropriateness of the animated videos among Maori cardiovascular patients
Timepoint [5] 447981 0
Immediately after watching the videos
Secondary outcome [6] 447982 0
To assess the cultural appropriateness of the animated videos among clinical staff
Timepoint [6] 447982 0
Following video review or clinical implementation with a patient
Secondary outcome [7] 448204 0
To assess the perceived clarity of the animated videos among clinical staff
Timepoint [7] 448204 0
Following video review or clinical implementation with a patient

Eligibility
Key inclusion criteria
The inclusion criteria for clinical staff will include individuals employed as healthcare professionals at Te Whatu Ora Te Toka Tumai, Auckland City Hospital. Eligible staff will have current or prior experience working within the cardiology department and be actively engaged in delivering counselling or educational support regarding cardiac medications to patients.

The inclusion criteria for patient participation will include Maori individuals, aged 18 years or older, currently hospitalized at Te Whatu Ora Te Toka Tumai, Auckland City Hospital, who have been admitted to cardiology services with a new diagnosis of acute coronary syndrome. Additionally, eligible patients must have been prescribed new cardiac medications for this diagnosis and express willingness to engage in discussions regarding their experience with animated educational videos with participating and eligible clinical staff.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give consent

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/09/2024
Date of last participant enrolment
Anticipated
Actual
27/05/2025
Date of last data collection
Anticipated
Actual
27/05/2025
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 26518 0
New Zealand
State/province [1] 26518 0
Auckland

Funding & Sponsors
Funding source category [1] 317188 0
Government body
Name [1] 317188 0
Health Research Council of New Zealand
Country [1] 317188 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 319472 0
None
Name [1] 319472 0
Address [1] 319472 0
Country [1] 319472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315933 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315933 0
Ethics committee country [1] 315933 0
New Zealand
Date submitted for ethics approval [1] 315933 0
27/06/2024
Approval date [1] 315933 0
01/08/2024
Ethics approval number [1] 315933 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136262 0
Dr Nataly Martini
Address 136262 0
University of Auckland, Grafton Campus, Pharmacy department, 85 Park Road, Grafton, Auckland 1023
Country 136262 0
New Zealand
Phone 136262 0
+64 09 3737599
Fax 136262 0
Email 136262 0
[email protected]
Contact person for public queries
Name 136263 0
Yasaman Mohammadi
Address 136263 0
University of Auckland, Grafton Campus, Pharmacy department, 85 Park Road, Grafton, Auckland 1023
Country 136263 0
New Zealand
Phone 136263 0
+64 278606629
Fax 136263 0
Email 136263 0
[email protected]
Contact person for scientific queries
Name 136264 0
Yasaman Mohammadi
Address 136264 0
University of Auckland, Grafton Campus, Pharmacy department, 85 Park Road, Grafton, Auckland 1023
Country 136264 0
New Zealand
Phone 136264 0
+64 278606629
Fax 136264 0
Email 136264 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.