Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000274673
Ethics application status
Approved
Date submitted
30/01/2023
Date registered
14/03/2023
Date last updated
14/03/2023
Date data sharing statement initially provided
14/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Tailored tele-health intervention for secondary prevention of cardiovascular disease
Scientific title
Tailored Telehealth Education And Counselling program to optimise secondary prevention of Heart disease for patients with cardiovascular disease living in Rural Australia (TEACH-RA study)
Secondary ID [1] 308361 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TEACH RA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 328823 0
Condition category
Condition code
Cardiovascular 325828 325828 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention for the study involves delivery of tailored telehealth education and counselling through phone call. A registered nurse will deliver the intervention. Patient education material is developed based on Heart Foundation recommendations and guidelines.
1st Intervention call: During this call, general information about heart disease, heart health, healthy lifestyle behaviour, secondary prevention and risk factors will be addressed. Patients will set goals for their particular lifestyle behaviour. Second and third intervention calls will be scheduled at three months interval. Adherence to recommended health behaviour will be monitored using checklist during follow up calls.
2nd intervention call and 3rd intervention call: Individualised education and counselling will be provided, and the intervention will be tailored to the patient’s health condition, need of lifestyle behaviour and health information gap. In addition, patient’s progress to goal achievement will be evaluated and adjusted during these calls. Depending on the patient’s individual condition the following may be addressed: weight reduction, smoking cessation, alcohol moderation, dietary modification, physical activity, medication adherence, blood pressure self-monitoring, how to recognise and respond to heart disease signs and symptoms. Each intervention call take about 45 minutes.
Intervention code [1] 325298 0
Lifestyle
Intervention code [2] 325299 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333672 0

A composite outcome of admission and rehospitalization due to cardiac event, this data will be collected from medical record from CATCH database.
Timepoint [1] 333672 0
3 months post first intervention call
6 months post first intervention call
Secondary outcome [1] 417896 0
knowledge of cardiovascular risk factors and lifestyle modification (smoking, alcohol, diet and physical exercise) assessed by Heart Disease Fact Questionnaire.
Timepoint [1] 417896 0
3 months post first intervention call
6 months post first intervention call
Secondary outcome [2] 418226 0
medication adherence assessed by medication adherence scale
Timepoint [2] 418226 0
3 months post first intervention call
6 months post first intervention call
Secondary outcome [3] 418227 0
health related quality of life assessed by Short form SF-36 questionnaire,
Timepoint [3] 418227 0
3 months post first intervention call
6 months post first intervention call
Secondary outcome [4] 418228 0
blood pressure recorded from medical record from CATCH database
Timepoint [4] 418228 0
3 months post first intervention call
6 months post first intervention call
Secondary outcome [5] 419307 0
cholesterol level recorded from medical record from CATCH database
Timepoint [5] 419307 0
3 months post first intervention call
6 months post first intervention call
Secondary outcome [6] 419308 0
blood glucose level recorded from medical record from CATCH database
Timepoint [6] 419308 0
3 months post first intervention call
6 months post first intervention call

Eligibility
Key inclusion criteria
Participants will be recruited from the Country Access to Cardiac Health (CATCH) database and the following CATCH program inclusion criteria will be used.

Patients with acute coronary syndrome/myocardial infarction, revascularisation procedure (angioplasty), stable and unstable angina, post coronary artery bypass grafting, post cardiac valve replacement surgery, and heart failure will be included.

Patients with arrhythmia management (medication or ablation), atrial fibrillation, coronary vasospasm, pre and post transcatheter heart valve repair or replacement, coronary slow flow and structural heart disease will be included on strong recommendation criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with intellectual disability or insufficient English knowledge to provide consent
and hearing or speech impairment will be excluded.

Study design
Purpose of the study
Prevention
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
Efficacy
Statistical methods / analysis
Data will be analysed using STATA, regression and appropriate statistical test will be conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
113
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312602 0
University
Name [1] 312602 0
The University of Sydney
Country [1] 312602 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 314216 0
None
Name [1] 314216 0
Address [1] 314216 0
Country [1] 314216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311928 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 311928 0
Ethics committee country [1] 311928 0
Australia
Date submitted for ethics approval [1] 311928 0
26/05/2022
Approval date [1] 311928 0
16/09/2022
Ethics approval number [1] 311928 0
142.22

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

Contacts
Principal investigator
Name 122870 0
Dr Lemma Bulto
Address 122870 0
Flinders University, College of Nursing and Health Sciences

Sturt Road, Bedford Park South Australia 5042
Country 122870 0
Australia
Phone 122870 0
+61 468647475
Fax 122870 0
Email 122870 0
lemma.bulto@flinders.edu.au
Contact person for public queries
Name 122871 0
Lemma Bulto
Address 122871 0
Flinders University, College of Nursing and Health Sciences

Sturt Road, Bedford Park South Australia 5042
Country 122871 0
Australia
Phone 122871 0
+61 468647475
Fax 122871 0
Email 122871 0
lemma.bulto@flinders.edu.au
Contact person for scientific queries
Name 122872 0
Lemma Bulto
Address 122872 0
Flinders University, College of Nursing and Health Sciences

Sturt Road, Bedford Park South Australia 5042
Country 122872 0
Australia
Phone 122872 0
+61 468647475
Fax 122872 0
Email 122872 0
lemma.bulto@flinders.eu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical issues


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.