Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000222842
Ethics application status
Approved
Date submitted
4/12/2020
Date registered
3/03/2021
Date last updated
4/04/2022
Date data sharing statement initially provided
3/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Country Heart Attack Prevention (CHAP) Project: implementation of a four-step cardiac rehabilitation model of care for rural and remote patients in South Australia
Scientific title
The Country Heart Attack Prevention (CHAP) Project: A four step model of care and clinical pathway for the translation of cardiac rehabilitation and secondary prevention guidelines into practice for rural and remote patients and observational cohort study
Secondary ID [1] 302942 0
nil
Universal Trial Number (UTN)
U1111-1262-2637
Trial acronym
CHAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular diseases 319971 0
cardiac rehabilitation 319972 0
Condition category
Condition code
Cardiovascular 317904 317904 0 0
Coronary heart disease
Cardiovascular 318176 318176 0 0
Other cardiovascular diseases
Cardiovascular 318180 318180 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The CHAP comprises a four-step model of care for cardiac rehabilitation (CR) that will be implemented in regional, remote and rural South Australia health services from 01/07/2021 to all adult (>=18 years) patients with acute myocardial infarction, hypertensive heart disease, ischemic heart disease, arrhythmias and heart failure regardless of their participation in this study. The steps, which will be developed and offered to participants in parallel and implemented into practice at least for the whole duration of the study (3 years), include:
1. An education program on CR co-designed with clinicians targeting all cardiologists, physicians, General Practitioners (GPs), nurses and allied health professionals working in regional, remote and rural South Australia. This program will be delivered through a website, web conferences and 3 two-hour workshops over 3 years (2020-2022), and will include themes related to lifestyle risk modification strategies, clinical management of risk factors, and CR referral and conduction. Education materials will be designed specifically for this study. Professionals will be asked to spend 45 minutes in online educational monthly sessions in a total of 11 sessions/year (there are no sessions in January). Professionals are recommended to use educational resources in the website according to their needs.
2. An automatic referral system across hospitals in regional, remote and rural South Australia that will identify eligible in-patients through DRGs and automatically refer them to a central telephone referral service by the Enterprise Patient Administrating System (EPAS). Additionally, a simple paper and fax-based referral system will be implemented to enable referrals to CR services by GPs working in primary care. This system will be available from 01/07/2021.
3. A web-based and a hybrid (face-to-face with the GP + telephone-based) modes of delivery of cardiac rehabilitation that, in addition to the existing ones (face-to-face and telephone-based), will be offered to all patients in regional, remote and rural South Australia from 01/07/2021. Patients will be able to choose among the modes of delivery according to their preferences.
-For the web-delivered program: Participants will have a personal log-in to the website. As per the National Heart Foundation and Australian Cardiac Rehabilitation Association (ACRA) guidelines, all cardiac rehabilitation programs will be comprised of 10 modules (Initial Assessment and Goal Setting, Heart Education and Self-management, Exercise Training and Physical Activity, Healthy Eating and Weight management, Tobacco Cessation and Alcohol Reduction, Medication Education and Review, Managing Medical Risk Factors, Psychosocial Wellbeing, Activities of Daily Living, Reassessment and Completion) that will be complete over 6-10 weeks. Patients will be offered the modules according to their individual needs. The anticipated duration of each web module completion is 30 minutes/week. It will be required that those in the web-delivery model to read short texts, watch short videos (about 5/module), self-report their dietary, physical activity, smoking and alcohol ingestion habits weekly through responding online questionnaires on the website. They will also be asked to set their personal goals by completing an online table in the beginning of the program and to complete four Heart Health Assessments (at the beginning of the project, 8-12 weeks, 6 and 12 months post-discharge). The Heart Health Assessments will have an expected duration of 20 minutes and will be comprised of questionnaires that assess lifestyle habits, exercise capacity, quality of life, mental health (depression and anxiety). In addition, all patients will be offered a 6 and 12-month follow-up that will be performed by the GP.
-For the hybrid program, Heart Health pre-assessment will occur at the beginning of the program (i.e. 1-2 weeks post-discharge) and will last 75 minutes (60 minutes with a Practice Nurse and 15 minutes with the GP). Re-assessments will occur 8-12 weeks, 6 months and 12 months post-discharge and will include 45 to 60 minutes consultations with the practice nurse, and 15-minute consultations with the GP. The CR program will be delivered by a nurse through telephone (10 modules, as per Heart Foundation and ACRA recommendations, of 30-minute duration over 6-10 weeks depending on the individual patient needs).
4-The quality of the programs will be assessed through an accreditation process of providers and programs based on the national key performance indicators established by ACRA and Heart Foundation. This accreditation process will be co-delivered in partnership with ACRA and the Department of Health of South Australia (SA Health) to all CR services in regional, remote and rural South Australia. The process will start from 01/07/2021.
Intervention code [1] 319235 0
Not applicable
Comparator / control treatment
The comparison group will be age, sex and DRG matched controls living in metropolitan areas of South Australia who receive metro Non-CHAP CR.
Control group
Active

Outcomes
Primary outcome [1] 325920 0
Cardiac rehabilitation attendance and completion assessed through the Country Access to Cardiac Health (CATCH) database. The CATCH database, which is managed by the Integrated Cardiac Clinical Network (iCCnet) of SA Health as part of the CATCH program, is a dataset established through standardised electronic data collection performed by CR nurses of minimum demography and clinical data of all patients undertaking CR in South Australia. Currently, this database is used for audits on CR effectiveness, identifying gaps in practice and driving service improvements.
Timepoint [1] 325920 0
12 months after CHAP model of care implementation
Secondary outcome [1] 389508 0
CR Referral rates assessed through the CATCH database.
Timepoint [1] 389508 0
12 months after CHAP model of care implementation
Secondary outcome [2] 389509 0
CVD-related hospital re-admission assessed through data linkage with the Integrated South Australian Integrated Activity Collection (ISAAC) database
Timepoint [2] 389509 0
30 days and 12 months after CHAP model of care implementation
Secondary outcome [3] 389510 0
CVD-related mortality through data linkage with the Integrated South Australian Integrated Activity Collection (ISAAC) database
Timepoint [3] 389510 0
30-day and 12-months after CHAP model of care implementation
Secondary outcome [4] 389511 0
Smoking assessed by self-report on number of cigarettes smoked throughout life (smoker if >=100 cigarettes) through the CATCH database
Timepoint [4] 389511 0
12 months after CHAP model of care implementation
Secondary outcome [5] 389512 0
Alcohol intake assessed through self-reported grams of alcohol consumed/week through the CATCH database
Timepoint [5] 389512 0
12 months after CHAP model of care implementation
Secondary outcome [6] 389513 0
Body mass index calculated based on self-reported weight and height by participants through the CATCH database
Timepoint [6] 389513 0
12 months after CHAP model of care implementation
Secondary outcome [7] 389514 0
General Nutrition Assessment assessed by the Health Eating Quiz collected through the CATCH database
Timepoint [7] 389514 0
12 months after CHAP model of care implementation
Secondary outcome [8] 389515 0
Glycolated haemoglobin assessed (Hb A1C) using serum assay ( methods and techniques may vary). Data collected through the CATCH database.
Timepoint [8] 389515 0
12 months after CHAP model of care implementation
Secondary outcome [9] 389521 0
Physical activity levels assessed by the 6-minute walk test. Data collected through the CATCH database.
Timepoint [9] 389521 0
12 months after CHAP model of care implementation
Secondary outcome [10] 389522 0
Medication adherence assessed by the Brief Medication Questionnaire. Data collected through the CATCH database.
Timepoint [10] 389522 0
12 months after CHAP model of care implementation
Secondary outcome [11] 389523 0
Anxiety assessed through the Cardiac Anxiety Questionnaire. Data collected through the CATCH database.
Timepoint [11] 389523 0
12 months after CHAP model of care implementation
Secondary outcome [12] 389524 0
Depression assessed by the Patient Health Questionnaire-2 (PHQ-2) and Patient Health Questionnaire-9 (PHQ-9). Data collected through the CATCH database.
Timepoint [12] 389524 0
12 months after CHAP model of care implementation
Secondary outcome [13] 389525 0
Quality of life assessed by the European Quality of Life- 5 Dimensions – 5 Levels and by the MLWHFQ: Minnesota Living with Heart Failure Questionnaire (only for patients with heart failure). Data collected through the CATCH database.
Timepoint [13] 389525 0
12 months after CHAP model of care implementation
Secondary outcome [14] 389526 0
Health literacy assessed by the Brief Health Literacy Screening tool. Data collected through the CATCH database.
Timepoint [14] 389526 0
12 months after CHAP model of care implementation
Secondary outcome [15] 408326 0
Emergency Department visits have been added as a secondary outcome and will be provided through linkage of the CATCH database with the South Australia Department of Health Emergency Department Database
Timepoint [15] 408326 0
30 days and 12 months after hospital discharge

Eligibility
Key inclusion criteria
Eligible participants will be defined according to the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: Australian clinical guidelines for the management of acute coronary syndromes 2016 by diagnostic related groups associated with acute myocardial infarction (I21, I21.0, I21.1, I21.2, I21.3, I21.4, I21.9), hypertensive heart disease ( I11.0, I11.9, I13, I13.0, I13.2, I13.9), ischemic heart disease (I20-I25), arrhythmias (I48, I48.0, I48.1, I48.2, I48.3, I48.4, I48.9, I49.9), heart failure (I50, I50.0, I50.1, I50.9). Eligibility will also be defined on the basis of procedures codes for coronary artery surgery, percutaneous coronary intervention, ventricular assist device. All rural and remote residents will be eligible to participate in this project including Aboriginal people.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Unpaired t tests, chi-square tests and Mann–Whitney U tests for non-normal data will be used for comparisons for the pre-post analysis of the CHAP model components. Statistical significance will be inferred if 2-tailed tests estimated P<0.05. Rates of referral, attendance and completion of CR; modification of risk factors; evidence base pharmacotherapy morbidity and mortality at 30 days and 12 months will be compared between CHAP and Non-CHAP attendees and presented as Odds Ratios and 95% Confidence Intervals. Matching will be conducted by grouping all cases and controls into relevant groupings of Age, Sex and DRG and analysed using the Mantel-Haenszel methods.

Cox regression models adjusted for clinical and social factors (age, sex, the Index of Relative Socio-economic Advantage and Disadvantage from the Australian Bureau of Statistics’ Socio-Economic Indexes for Areas score Accessibility and Remoteness Index of Australia primary cardiac diagnosis, Charlson Index in-hospital length of stay, prior heart failure, coronary disease, atrial fibrillation, revascularisation, malignancy) will be performed to understand the association between exposure to the CHAP model and attendance. For clinical outcomes (30-day and 12-month hospital CVD-related hospital readmission, 30-day and 12-month CVD-related mortality), the model will also be adjusted for CR attendance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2021
Actual
1/07/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
4892
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307365 0
Government body
Name [1] 307365 0
NHMRC Partnership Grant
Country [1] 307365 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide 5001, South Australia
Country
Australia
Secondary sponsor category [1] 308006 0
University
Name [1] 308006 0
Monash University
Address [1] 308006 0
Monash University
Victoria 3800
Australia
Country [1] 308006 0
Australia
Secondary sponsor category [2] 308012 0
Charities/Societies/Foundations
Name [2] 308012 0
Flinders Foundation
Address [2] 308012 0
Flinders Drive
Bedford Park 5042 SA
Country [2] 308012 0
Australia
Secondary sponsor category [3] 308013 0
Government body
Name [3] 308013 0
Department for Health and Wellbeing South Australia (SA) Health
Address [3] 308013 0
Citi Centre Building 11 Hindmarsh Square Adelaide South Australia 5000
Country [3] 308013 0
Australia
Secondary sponsor category [4] 308014 0
Government body
Name [4] 308014 0
Barossa Hills Fleurie Local Health Network (iccnet SA, Rural Support Service)
Address [4] 308014 0
22 King William Street, Adelaide, South Australia, 5000
Country [4] 308014 0
Australia
Secondary sponsor category [5] 308015 0
Government body
Name [5] 308015 0
Country South Australia Primary Health Network
Address [5] 308015 0
Beckwith Park
30 Tanunda Road
Nuriootpa SA 5355
Country [5] 308015 0
Australia
Secondary sponsor category [6] 308018 0
Charities/Societies/Foundations
Name [6] 308018 0
the Cardiac Society of Australia and New Zealand
Address [6] 308018 0
Suite 4, Level 12
189 Kent Street
SYDNEY NSW 2000
Country [6] 308018 0
Australia
Secondary sponsor category [7] 308019 0
Charities/Societies/Foundations
Name [7] 308019 0
Royal Australian College of General Practitioners
Address [7] 308019 0
Level 7, 12 Mount street
North Sydney, NSW, 2060
Country [7] 308019 0
Australia
Secondary sponsor category [8] 308020 0
Charities/Societies/Foundations
Name [8] 308020 0
Australian Cardiovascular Health and Rehabilitation Association Inc.
Address [8] 308020 0
Level 3, 33-35 Atchison Street
St Leonards NSW 2065
Country [8] 308020 0
Australia
Secondary sponsor category [9] 308021 0
Charities/Societies/Foundations
Name [9] 308021 0
Exercise and Sports Science Australia
Address [9] 308021 0
ESSA Locked Bag 4102
Ascot, QLD, 4007
Country [9] 308021 0
Australia
Secondary sponsor category [10] 308227 0
Charities/Societies/Foundations
Name [10] 308227 0
The University of Adelaide
Address [10] 308227 0
The University of Adelaide
SA 5005
AUSTRALIA
Country [10] 308227 0
Australia
Secondary sponsor category [11] 308228 0
Charities/Societies/Foundations
Name [11] 308228 0
University of South Australia
Address [11] 308228 0
UniSA International University of South Australia, GPO Box 2471, Adelaide, South Australia 5001, Australia
Country [11] 308228 0
Australia
Secondary sponsor category [12] 308229 0
Charities/Societies/Foundations
Name [12] 308229 0
Deakin University
Address [12] 308229 0
221 Burwood Highway
Burwood
Victoria 3125 Australia
Country [12] 308229 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307452 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 307452 0
Ethics committee country [1] 307452 0
Australia
Date submitted for ethics approval [1] 307452 0
23/03/2020
Approval date [1] 307452 0
28/04/2020
Ethics approval number [1] 307452 0
HREC/20/SAC/78

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

Contacts
Principal investigator
Name 107282 0
Prof Robyn Clark
Address 107282 0
Sturt North N215
Sturt Road
Flinders University
Bedford Park, SA
5042
Country 107282 0
Australia
Phone 107282 0
+61 8 82013266
Fax 107282 0
Email 107282 0
[email protected]
Contact person for public queries
Name 107283 0
Robyn Clark
Address 107283 0
Sturt North N215
Sturt Road
Flinders University
Bedford Park, SA
5042
Country 107283 0
Australia
Phone 107283 0
+61 8 82013266
Fax 107283 0
Email 107283 0
[email protected]
Contact person for scientific queries
Name 107284 0
Robyn Clark
Address 107284 0
Sturt North N215
Sturt Road
Flinders University
Bedford Park, SA
5042
Country 107284 0
Australia
Phone 107284 0
+61 8 82013266
Fax 107284 0
Email 107284 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
30/06/2023 to 30/04/2028
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator. Requests should be directed to Prof Robyn Clark, [email protected]


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
EmbaseAssessing the quality of cardiac rehabilitation programs by measuring adherence to the Australian quality indicators.2022https://dx.doi.org/10.1186/s12913-022-07667-2
EmbaseImplementation and prospective evaluation of the Country Heart Attack Prevention model of care to improve attendance and completion of cardiac rehabilitation for patients with cardiovascular diseases living in rural Australia: A study protocol.2022https://dx.doi.org/10.1136/bmjopen-2021-054558
N.B. These documents automatically identified may not have been verified by the study sponsor.