Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000557730
Ethics application status
Approved
Date submitted
16/04/2013
Date registered
17/05/2013
Date last updated
28/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Heart Health Study - increasing cardiovascular risk assessment in first degree relatives of patients with premature heart disease by provision of written and verbal advice
Scientific title
Increasing cardiovascular risk assessment in first degree relatives of patients with premature heart disease by provision of written and verbal advice
Secondary ID [1] 282230 0
Nil
Universal Trial Number (UTN)
U1111-1141-3434
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prevention of cardiovascular disease 252074 0
Condition category
Condition code
Cardiovascular 252282 252282 0 0
Coronary heart disease
Public Health 289501 289501 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients recruited with premature heart disease are asked to identify their first degree relatives aged 18 years and over, and to provide information about the study to them personally or by mailing. The study information sheet provided to their relatives (the intervention group) explains the study and provides a brief explanation about family history of premature heart disease and cardiovascular risk factors, and the benefits of risk factor assessment. It includes a recommendation that the relative make an appointment to attend their general practitioner (GP) for a cardiovascular risk assessment (without cost to them), and instruction to contact the Heart Foundation for free telephone advice about heart disease. It also includes an option for the relative to receive further advice or have any questions answered about heart disease in the form of a telephone call with either a GP or a nurse depending on participant preference.
Intervention code [1] 286839 0
Early detection / Screening
Intervention code [2] 287176 0
Prevention
Comparator / control treatment
Standard care relatives (of IHD patients) are provided with an information sheet that explains the study and provides a brief explanation about family history of premature heart disease and cardiovascular risk factors only. It does not include a recommendation to attend their GP for a cardiovascular risk assessment, nor to contact the Heart Foundation . It does not include an option for further advice about heart disease from a GP or nurse.
Control group
Active

Outcomes
Primary outcome [1] 289209 0
Proportion of relatives (of patients with premature ischaemic heart disease (PIHD)) attending their GP for cardiovascular risk assessment
Timepoint [1] 289209 0
6 months after patients’ PIHD event and randomisation
Secondary outcome [1] 302041 0
Proportion of relatives (of patients with PIHD) who responded to the invitation to receive verbal advice from either a GP or nurse depending on participant preference?
Timepoint [1] 302041 0
6 months after patients’ PIHD event and randomisation
Secondary outcome [2] 302042 0
Was attendance for risk assessment more likely in the group receiving verbal advice?
Timepoint [2] 302042 0
6 months after patients’ IHD event and randomisation
Secondary outcome [3] 302043 0
How many risk factors have been identified by their GP since their relative’s PIHD event and are being actively managed (by dietary modification, lifestyle modification or medication) at 6 months in both groups?

For the intervention group: risk factors identified at the cardiovascular risk assessment appointment with GP since relative’s PIHD event 6 months ago.

For the standard care group: risk factors identified at any appointment with GP since relative’s PIHD event 6 months ago
Timepoint [3] 302043 0
6 months after patients’ PIHD event and randomisation

Eligibility
Key inclusion criteria
Patients: hospitalised with their first premature ischaemic heart disease (PIHD) event, with the event determined as occurring before age 55 in men, and before age 65 in women. An IHD event is defined as any one of the following: non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI), unstable angina and coronary revascularisation (coronary artery bypass grafting, coronary angioplasty with or without coronary stenting).

Relatives: siblings and children (18 years and over) of the patient, without diagnosed IHD, and residing in Australia, are eligible for this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluding: patients who are terminally ill, experiencing dementia and/or other significant cognitive impairment, unable to speak English, illiterate, and any condition that their treating doctor believes warrants intensive family follow-up and intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A consecutive series of 140 patients hospitalised with PIHD will be recruited prospectively from Flinders Medical Centre/Flinders Private Hospital and the Royal Adelaide Hospital. Patients will then send an invitation on behalf of the researchers to their first degree relatives to participate. All participants will be aged over 18 years. A consecutive series of patients hospitalised with PIHD will be invited to participate. All participants are aged 18 years or over. Patients will be asked to send an invitation on behalf of the researchers to their first degree relatives (aged 18 years and over) to participate. With 140 patients recruited to this study, we anticipate a potential pool of 490 first degree relatives to invite to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule was created for both hospital sites using computerised sequence generation. Intervention was assigned 'A' and Standard Care was assigned 'B'. Individually sealed enveloples containing letters according to the randomisation shedule were provided to the research nurse at each site, who was instructed to open each envelope sequentially, after consent to particpate was obtained from the patient. The appropriate set of information packs were provided
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total minimum sample size of 140 patients and 136 relatives will be recruited into the trial. The sample size makes the following assumptions:
- 30% of patients will agree to participate in the study (of these approximately 10% will die or otherwise not be able to participate in the first 6 months of the study)
- each patient has on average, three first-degree relatives (inclusive of sibling(s) and children)
- 20% of relatives will be ineligible due to an existing IHD diagnosis, while 50% of eligible relatives will agree to participate in the study, allowing for a design effect of 1.1 (family intra-cluster correlation coefficient of 0.05, 1+(3-1)*0.05=1.1)
- A maximum dropout rate for relatives in the order of 10% over the course of the study.

This minimum study sample size will be sufficient to detect an increase of 25% (absolute) in general practitioner attendance for risk-assessment, with 25% of standard care relatives attending in the 6 months after the event, compared with 50% of relatives in the intervention group, and allowing for a correlation of 0.25 with other covariates (e.g. age, gender etc), with at least 80% power (90% power for a one sided test) at the 5% significance level.

Descriptive statistics will be used to summarise the primary and secondary outcome measures. Kappa statistic will be used to measure the strength of agreement between self perceived and absolute cardiovascular risk values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/07/2009
Date of last participant enrolment
Anticipated
Actual
11/07/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 830 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 831 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 832 0
Flinders Private Hospital - Bedford Park
Recruitment postcode(s) [1] 6644 0
5000 - Adelaide
Recruitment postcode(s) [2] 6645 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 286989 0
Government body
Name [1] 286989 0
National Health and Medical Research Council (NHMRC)
Country [1] 286989 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace,
Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 285778 0
None
Name [1] 285778 0
Address [1] 285778 0
Country [1] 285778 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289039 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 289039 0
Ethics committee country [1] 289039 0
Australia
Date submitted for ethics approval [1] 289039 0
Approval date [1] 289039 0
27/05/2009
Ethics approval number [1] 289039 0
131/09
Ethics committee name [2] 289040 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 289040 0
Ethics committee country [2] 289040 0
Australia
Date submitted for ethics approval [2] 289040 0
Approval date [2] 289040 0
29/05/2009
Ethics approval number [2] 289040 0
090425

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

Contacts
Principal investigator
Name 30431 0
Prof Nigel Stocks
Address 30431 0
Discipline of General Practice
The University of Adelaide,
SA 5005
Country 30431 0
Australia
Phone 30431 0
+61 8 8313 3462
Fax 30431 0
+61 8 8313 2511
Email 30431 0
[email protected]
Contact person for public queries
Name 13678 0
Nigel Stocks
Address 13678 0
Discipline of General Practice
The University of Adelaide,
SA 5005
Country 13678 0
Australia
Phone 13678 0
+61 8 8313 3462
Fax 13678 0
+61 8 8313 2511
Email 13678 0
[email protected]
Contact person for scientific queries
Name 4606 0
Nigel Stocks
Address 4606 0
Discipline of General Practice
The University of Adelaide,
SA 5005
Country 4606 0
Australia
Phone 4606 0
+61 8 8313 6266
Fax 4606 0
+61 8 8313 2511
Email 4606 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe Heart Health Study - increasing cardiovascular risk assessment in family practice for first degree relatives of patients with premature ischaemic heart disease: a randomised controlled trial.2015https://dx.doi.org/10.1186/s12875-015-0328-4
N.B. These documents automatically identified may not have been verified by the study sponsor.