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Trial registered on ANZCTR


Registration number
ACTRN12612001309875
Ethics application status
Approved
Date submitted
21/11/2012
Date registered
18/12/2012
Date last updated
23/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Strengthening health literacy among Indigenous people living with cardiovascular disease, their families, and health care providers
Scientific title
Strengthening health literacy among Indigenous people living with cardiovascular disease, their families, and health care providers
Secondary ID [1] 281406 0
Health Research Council of New Zealand 09/640b (Number given by funding agency)
National Health and Medical Research council (Australia)
Canadian Institutes of Health Research (CIHR)
Universal Trial Number (UTN)
U1111-1135-9259
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 287651 0
Condition category
Condition code
Public Health 287987 287987 0 0
Health service research
Public Health 288215 288215 0 0
Health promotion/education
Cardiovascular 288325 288325 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an intervention about cardiovascular disease drugs. Participants will receive a standardised set of information about cardiovascular disease medicines during an interactive
session (using an specially designed Android tablet application and a booklet) with a nurse. The booklet can be
taken away by the participants. The session will be repeated twice (i.e. 3 times in total). The second session will take place one week after the first, and the last session will take place one month after the first session. Each session will be 40 - 60 minutes in duration. Outcome measures will be done before and after each session. We will collect blood pressure and lipid data from clinical records and demographic data. Participants will be asked to invite any whanau members they would like to attend the session. The following information is included in the written resource 1) for statins, beta blockers, ACE inhibitor and aspirin medication groups - why these medications are taken, how to take them, side effects, and how participants know if the medicines are working. 2) general information about cardiovascular disease - what it is, how it affects the heart and brain, what can be done to manage it,what is blood pressure, what is cholesterol; 3) how to read a medicine label, 4) questions for health professionals. The session involves an education session about the topics mentioned above. The app is used as an interactive teaching tool to assist in the delivery of information in these session. One function of the app is that, after the nurse and participant enter information about each of their medications, a pill card is printed out.
Intervention code [1] 286098 0
Prevention
Comparator / control treatment
This is pre - post design. Data will be collected before, during and at the end of participation in the trial.

There is no comparator or control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288196 0
Knowledge about the CVD medications that the participant is currently taking. These are assessed using an interviewer administered questionnaire designed specifically for the trial.
Timepoint [1] 288196 0
At baseline
Immediately after first intervention session
Immediately before second intervention session
Immediately after second intervention session
Immediately before third intervention session
Immediately after third intervention session
Primary outcome [2] 288197 0
Knowledge of personal treatment targets for lipids and blood pressure. These are assessed using an interviewer administered questionnaire designed specifically for the trial.
Timepoint [2] 288197 0
At baseline
Immediately after first intervention session
Immediately before second intervention session
Immediately after second intervention session
Immediately before third intervention session
Immediately after third intervention session
Primary outcome [3] 288198 0
during the intervention the participant nominates up to three questions they would like to ask their health professional. This outcome will assess whether they have used this/these question(s). These are assessed using an interviewer administered questionnaire designed specifically for the trial.
Timepoint [3] 288198 0
Immediately before second intervention session
Immediately before third intervention session
Secondary outcome [1] 299591 0
Health literacy practices demonstrated during the outcomes assessment process. Assessed using an interviewer administered questionnaire designed specifically for the trial and by observation of the HL skills and practices that the participant exhibits during the assessment of medication and treatment target knowledge.
Timepoint [1] 299591 0
At baseline
Immediately after first intervention session
Immediately before second intervention session
Immediately after second intervention session
Immediately before third intervention session
Immediately after third intervention session

Eligibility
Key inclusion criteria
Member of indigenous ethnic group who have been diagnosed with angina pectoris, myocardial infarction, transient ischaemic attack or stroke. In Canada participants will also be eligible cardiovascular risk assessment score above the cut off (assessed as being at greater than or equal to 15% risk of experiencing a cardiovascular event in the next 10 years according Framingham General Cardiovascular Risk Assessment Scoring)

AND are taking at least two of the following types of medicines: a statin; Aspirin; a beta blocker; an ACE inhibitor.
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive deficit, such as receptive or expressive aphasia, that interfere with the ability to participate in the intervention will not be eligible for the trial.

Conditions that mean that the person is unable to give informed consent (e.g. acute psychotic illness, dementia).

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)
After eligibility is determined potential participants will be approached by a staff member of the service who is not / has not been involved in the person’s clinical care. The staff member will explain the study to the potential participant and ask if they are interested in participating. If the potential participant is interested they will then be approached by the research nurse who will arrange a meeting, explain the study, provide participants information and consent forms, answer questions and, where indicated, obtain consent to participate. Written consent to participate will be obtained before any study-specific procedures are conducted. There is no allocation to treatment as all participants will receive the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not a randomised trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A health professional will deliver the standardised set of information about CVD medicines that are used to reduce the risk of future CVD events in people who have previously experienced a CVD or are at high risk of such an event in the next five years. They will use an interactive tablet application and a written resource during their sessions with the participants. The resources are culturally appropriate, have been designed for people with low levels of health literacy, and incorporate principles of adult education.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Participant size was reduced as pool of eligible people at sites was smaller than anticipated.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 5967 0
3065
Recruitment outside Australia
Country [1] 4744 0
New Zealand
State/province [1] 4744 0
Auckland and East Coast
Country [2] 4745 0
Canada
State/province [2] 4745 0
Ontario

Funding & Sponsors
Funding source category [1] 286167 0
Government body
Name [1] 286167 0
Health Research Council of New Zealand
Address [1] 286167 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 286167 0
New Zealand
Funding source category [2] 286290 0
Government body
Name [2] 286290 0
National Health and Medical Research council
Address [2] 286290 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Australia
Country [2] 286290 0
Australia
Funding source category [3] 286291 0
Government body
Name [3] 286291 0
Canadian Institutes of Health Research
Address [3] 286291 0
160 Elgin Street, 9th Floor
Address Locator 4809A
Ottawa, ON, K1A 0W9
Canada
Country [3] 286291 0
Canada
Primary sponsor type
Individual
Name
Dr Sue Crengle
Address
School of Population Health
FMHS
University of Auckland
Private Bag 92019
Wellesley St
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284979 0
Individual
Name [1] 284979 0
Dr Janet Smylie
Address [1] 284979 0
Centre for research on inner city health,
Keenan Research Centre in the Li Ka Shing Knowledge Institute,
St Michael's Hospital,
Toronto M5B 1W8
Country [1] 284979 0
Canada
Secondary sponsor category [2] 285083 0
Individual
Name [2] 285083 0
Associate Professor Margaret Kelaher
Address [2] 285083 0
Level: 04 Room: 438,
207 Bouverie St.,
Parkville
Melbourne Vic 3010
Country [2] 285083 0
Australia
Secondary sponsor category [3] 285084 0
Individual
Name [3] 285084 0
Joanne Luke
Address [3] 285084 0
Victorian Aboriginal Health Service
186 Nicholson Street
Fitzroy, Melbourne
Vic 3065
Country [3] 285084 0
Australia
Other collaborator category [1] 277157 0
Individual
Name [1] 277157 0
Dr Matire Harwood
Address [1] 277157 0
Te Kupenga Hauora Maori,
SOPH,
University of Auckland,
Private Bag 92109,
Wellesley St 1142
Auckland
Country [1] 277157 0
New Zealand
Other collaborator category [2] 277158 0
Individual
Name [2] 277158 0
Dr Jennie Harre Hindmarsh
Address [2] 277158 0
Ngati Porou Hauora
PO Box 2
TE PUIA SPRINGS
Tairawhiti East Coast 4079
Country [2] 277158 0
New Zealand
Other collaborator category [3] 277159 0
Individual
Name [3] 277159 0
Ms Marion Hakaraia
Address [3] 277159 0
Te Hononga o Tamaki me Hoturoa
519 Great South Road
Otahuhu
Auckland 1620
Country [3] 277159 0
New Zealand
Other collaborator category [4] 277160 0
Individual
Name [4] 277160 0
Ms Susan Reid
Address [4] 277160 0
Workbase
2 Vermont Street
Ponsonby 1011
Auckland
Country [4] 277160 0
New Zealand
Other collaborator category [5] 277188 0
Individual
Name [5] 277188 0
Dr Marcia Anderson
Address [5] 277188 0
Department of Community Health Sciences
Faculty of Medicine
University of Manitoba
S113B- 750 Bannatyne Avenue
Winnipeg, MB
R3E 0W3
Country [5] 277188 0
Canada
Other collaborator category [6] 277189 0
Individual
Name [6] 277189 0
Nancy Cooper
Address [6] 277189 0
Department of Community Health Sciences
Faculty of Medicine
University of Manitoba
S113B- 750 Bannatyne Avenue
Winnipeg, MB
R3E 0W3
Country [6] 277189 0
Canada
Other collaborator category [7] 277190 0
Individual
Name [7] 277190 0
Dr Sanjeev Sridharan
Address [7] 277190 0
Keenan Research Centre in the Li Ka Shing Knowledge Institute,
St Michael's Hospital,
Toronto M5B 1W8
Country [7] 277190 0
Canada
Other collaborator category [8] 277191 0
Individual
Name [8] 277191 0
Dr Sanjeev Sridharan
Address [8] 277191 0
Keenan Research Centre in the Li Ka Shing Knowledge Institute,
St Michael's Hospital,
Toronto M5B 1W8
Country [8] 277191 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288229 0
Health and Disability Ethics Committees
Ethics committee address [1] 288229 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288229 0
New Zealand
Date submitted for ethics approval [1] 288229 0
19/11/2012
Approval date [1] 288229 0
Ethics approval number [1] 288229 0
12/NTB/66
Ethics committee name [2] 288366 0
Human Research Ethics
Ethics committee address [2] 288366 0
Office for Research Ethics and Integrity
Level 1, 780 Elizabeth Street, Parkville
The University of Melbourne
Victoria 3010
Australia 3010
Ethics committee country [2] 288366 0
Australia
Date submitted for ethics approval [2] 288366 0
09/08/2012
Approval date [2] 288366 0
04/12/2012
Ethics approval number [2] 288366 0
1238349
Ethics committee name [3] 288437 0
Research Ethics Board, St. Michael's Hospital
Ethics committee address [3] 288437 0
30 Bond Street
Toronto
Ontario M5B 1W8
Ethics committee country [3] 288437 0
Canada
Date submitted for ethics approval [3] 288437 0
Approval date [3] 288437 0
04/12/2012
Ethics approval number [3] 288437 0

Summary
Brief summary
A health professional will deliver the standardised set of information about CVD medicines that are used to reduce the risk of future CVD events in people who have previously experienced a CVD or are at high risk of such an event in the next five years. They will use an interactive tablet application and a written resource during their sessions with the participants. We hypothesis that this will improve participants knowledge about CVD medications and will build their health literacy practices around
CVD medications especially with regard to asking questions about their CVD medicines.
Trial website
Nil
Trial related presentations / publications
Improving health literacy about cardiovascular disease medications – implementing a clinical trial in two Maori providers. Hui Whakapiripiri, Auckland, 10 July 2014
Sue Crengle, Michelle Lambert, Matire Harwood, Susan Reid, Jennie Harré Hindmarsh, Julia Brooking, Marion Hakaraia, Lisa Reddy
CVD Medication health literacy among indigenous peoples: Results of an intervention trial in primary care services. Australasian Long Term Conditions conference, Auckland, 30th July 2014. Sue Crengle, Susan Reid
Results of a primary care based, nurse-delivered, cardiovascular disease medication health literacy intervention trial for Maori people with cardiovascular disease. Rural health conference. Dunedin, 1st April 2016 Dr Sue Crengle
Results of a primary care based, nurse-delivered, cardiovascular disease medication health literacy intervention trial for Maori people with cardiovascular disease. Presentation at Te Akoranga a Maui General Practitioner peer review group Dr Sue Crengle, Auckland, 30th April 2016
Results of a primary care based, nurse-delivered, cardiovascular disease medication health literacy intervention trial for Maori people with cardiovascular disease. Royal NZ College of General Practitioners Conference, Auckland, 30th July 2016. Dr Sue Crengle

Publications
Crengle, S., et al., Cardiovascular disease medication health literacy among Indigenous peoples: design and protocol of an intervention trial in Indigenous primary care services. BMC Public Health, 2014. 14: p. 714.
Lambert, M., et al., Health literacy: health professionals' understandings and their perceptions of barriers that Indigenous patients encounter. BMC Health Serv Res, 2014. 14(1): p. 614.
Public notes

Contacts
Principal investigator
Name 34843 0
A/Prof Sue Crengle
Address 34843 0
Department of Preventive & Social Medicine/Te Tari Hauora Tumatanui
Dunedin School of Medicine/Te Kura Whaiora o Otepoti
University of Otago/Te Whare Wanaka o Otago
PO Box 56
Dunedin 9054
Country 34843 0
New Zealand
Phone 34843 0
+6421832346
Fax 34843 0
Email 34843 0
sue.crengle@otago.ac.nz
Contact person for public queries
Name 18090 0
Dr Sue Crengle
Address 18090 0
Department of Preventive & Social Medicine/Te Tari Hauora Tumatanui
Dunedin School of Medicine/Te Kura Whaiora o Otepoti
University of Otago/Te Whare Wanaka o Otago
PO Box 56
Dunedin 9054
Country 18090 0
New Zealand
Phone 18090 0
+64 21 832 346
Fax 18090 0
Email 18090 0
sue.crengle@otago.ac.nz
Contact person for scientific queries
Name 9018 0
Dr Sue Crengle
Address 9018 0
Department of Preventive & Social Medicine/Te Tari Hauora Tumatanui
Dunedin School of Medicine/Te Kura Whaiora o Otepoti
University of Otago/Te Whare Wanaka o Otago
PO Box 56
Dunedin 9054
Country 9018 0
New Zealand
Phone 9018 0
+64 21 832 346
Fax 9018 0
Email 9018 0
sue.crengle@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary