Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000102976
Ethics application status
Approved
Date submitted
12/12/2019
Date registered
5/02/2020
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Getting Back on Track after a cardiac event: Trial of an online patient self-management program comparing self-directed and health-professional supported delivery options
Scientific title
Getting Back on Track after a cardiac event: Trial of an online patient self-management program comparing self-directed and health-professional supported delivery options
Secondary ID [1] 300069 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac disease 315589 0
emotional wellbeing 315689 0
Condition category
Condition code
Cardiovascular 313876 313876 0 0
Coronary heart disease
Mental Health 313974 313974 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Australian Centre for Heart Health (ACHH) developed the Back on Track online program to support patients who have had an acute cardiac event. The program was developed using the principles of self-management, patient centred care, cognitive behaviour therapy and motivational interviewing. The Back on Track program is designed to help patients manage their health behaviours and emotional wellbeing. The online Back on Track program begins with a mandatory goal-setting module, followed by four self-selected modules relating to a) dietary change; b) physical activity and reduced sitting; c) smoking cessation; and d) cardiac blues, anxiety and depression. Each module includes written information as well as motivational interviewing tasks such as comparing advantages and disadvantages of each behaviour change, and preparing action plans and coping plans for making changes. Each module takes up to one hour to complete.
This project will trial the Back on Track online program, and test two methods of program delivery – one self-directed by the patient (Group 1), and one supported with two telephone sessions with a health psychologist (Group 2). Both Group 1 and Group 2 patients will be asked to complete online modules that are relevant to them, in their own time and in any order. Group 2 patients will also be offered two telephone sessions (each up to 45 minutes duration) with a registered and experienced Health Psychologist to assist them in goal-setting and overall self-management while undertaking program modules. The health psychologist(s) will be trained by Associate Professor Rosemary Higgins who designed the Back on Track program and prepared the telephone scripts for the two support sessions. The first telephone session will occur when patients are completing the mandatory online goal-setting module. The health psychologist will use motivational interviewing strategies to support patients to articulate clear and achievable goals and to identify areas of behavioural and emotional self-management that they want to address. At completion of the first session, the second telephone session will be scheduled for a mutually agreed time. An SMS reminder will be sent 24-hours prior to each telephone session appointment to facilitate engagement.

Assessing adherence. Both Group 1 and 2 participants will be asked in the post-program questionnaire to indicate which Back on Track modules they completed. In addition, website analytics will be recorded, including number of modules started and completed, number of logins, time spent online for each module. Completion and time of each telephone session will be recorded for Group 2 participants.
Intervention code [1] 316344 0
Rehabilitation
Intervention code [2] 316345 0
Lifestyle
Intervention code [3] 316347 0
Behaviour
Comparator / control treatment
The comparator group will be Group 1, comprising participants in the self-directed arm.
Control group
Active

Outcomes
Primary outcome [1] 322281 0
As the first primary outcome, we will examine differences between groups 1 and 2 in the proportion of patients who were classified as non-depressed at baseline, post-program and follow-up (according to a PHQ-9 score of <6). PHQ-2 and PHQ-4 scores will also be examined as these scores exclude more ‘somatic’ items such as feeling tired, having problems with sleep and appetite which may be confounded by other physical issues.

Timepoint [1] 322281 0
Pre-program, immediately post-program (2 months after registration), and at 6 months (4 months after program completion).
Primary outcome [2] 322385 0
As the second primary outcome, we will examine differences between groups 1 and 2 in the proportion of patients who were achieving physical activity guidelines of at least 150 minutes of physical activity per week at baseline, post-program and 6 month follow-up. Active Australia Survey will be used to assess physical activity. The 8-item AAS measures frequency of walking, moderate activity and vigorous activity in the last two weeks. Participants will be classified, according to the National Heart Foundation of Australia (NHFA), as achieving the recommended target for adequate physical activity for CHD secondary prevention if they have been engaged in at least 150 minutes of physical activity per week combined across the three domains assessed.
Timepoint [2] 322385 0
Pre-program, immediately post-program (2 months after registration), and at 6 months (4 months after program completion; 6 months after registration).
Primary outcome [3] 322386 0
As the third primary outcome, we will examine differences between groups 1 and 2 in the proportion of patients who were achieving healthy dietary guidelines of DQT scores >60% at baseline, post-program and follow-up.
Timepoint [3] 322386 0
Pre-program, immediately post-program (2 months after registration), and at 6 months (4 months after program completion; 6 months after registration).
Secondary outcome [1] 377942 0
Secondary outcome measures will include change over time in smoking rates. Amongst smokers, the proportion of people who have quit smoking will be compared for the two groups. Smoking status will be assessed by self-report by asking participants “Are you a smoker?” Current smokers will be asked how many cigarettes they smoke per day. Former smokers will be asked when they quit smoking.
Timepoint [1] 377942 0
Pre-program, immediately post-program (2 months after registration), and at 6 months (4 months after program completion).
Secondary outcome [2] 378277 0
Secondary outcome measures will also include change over time in anxiety. Scores on the GAD-7 will be compared between groups 1 and 2 using repeated measures analysis of variance (ANOVA). Multiple regression analysis, with group entered as a potential predictor, will be used to predict patients with greatest improvements in GAD-7 scores.
Timepoint [2] 378277 0
Pre-program, immediately post-program (2 months after registration), and at 6 months (4 months after program completion).
Secondary outcome [3] 378278 0
Secondary outcome measures will also include change over time in quality of life. Scores on the WHO-5 and SF-12 will be compared between groups 1 and 2 using repeated measures analysis of variance (ANOVA). Multiple regression analysis, with group entered as a potential predictor, will be used to predict patients with greatest improvements in WHO-5 and SF-12 scores.
Timepoint [3] 378278 0
Pre-program, immediately post-program (2 months after registration), and at 6 months (4 months after program completion).
Secondary outcome [4] 378279 0
Secondary outcome measures will also include change over time in self-efficacy Scores on the self-efficacy scale will be compared between groups 1 and 2 using repeated measures analysis of variance (ANOVA). Multiple regression analysis, with group entered as a potential predictor, will be used to predict patients with greatest improvements in self-efficacy scores.
Timepoint [4] 378279 0
Pre-program, immediately post-program (2 months after registration), and at 6 months (4 months after program completion).
Secondary outcome [5] 378280 0
Secondary outcome measures will also include change over time in readiness to change behaviours and emotions. Scores on the readiness to change scales will be compared between groups 1 and 2 using repeated measures analysis of variance (ANOVA). Multiple regression analysis, with group entered as a potential predictor, will be used to predict patients with greatest improvements in readiness to change scores.
Timepoint [5] 378280 0
Pre-program, immediately post-program (2 months after registration), and at 6 months (4 months after program completion; 6 months after registration).
Secondary outcome [6] 378281 0
Program acceptability will be assessed at post-program only (2 months after program access) using a 6-item scale developed specifically for this study. The acceptability questionnaire asks participants the extent to which the program was helpful, gave them strategies for lifestyle change, increased their confidence, increased their motivation, and helped them manage their emotions, and whether they would recommend the program to others.
Timepoint [6] 378281 0
Program acceptability will be assessed at post-program only; 2 months after program registration and access.

Eligibility
Key inclusion criteria
Participants will be adults (over 18 years of age) who have had an acute cardiac event, namely acute myocardial infarction (AMI), coronary artery bypass graft surgery (CABGS), percutaneous coronary intervention (PCI), or unstable angina (UA), in the past 12 months. Participants will be required to be fluent in English language in order to comprehend the Back on Track program, which is currently available in English only.
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 of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Research Fellow will receive the registration form from interested participants, whereas random allocation will be undertaken by an Administrative Assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once registered, participants will be randomly allocated to either the self-directed arm (Group 1) or the supported (Group 2) arm of the trial using an automatic random allocation numbering system (www.randomization.com).
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
Sample size and power
Sample size calculation indicated that 147 subjects per group or a total of 294 will be required to detect, with 90% power and type I error of 5% (two-tailed), an absolute intervention effect of 17% based on the primary outcome variable, expected PHQ-9 depression response (defined as PHQ-9 score of less than 6 and a reduction in PHQ-9 score of at least 5 points, 4 months after randomisation) This intake number accounts for 10% attrition over the course of the study to the 4-month follow-up assessment (estimated sample sizes at 4-month follow-up: N=264; N per group=132). Sample size was calculated using Stata v16 and was based on a depression care management intervention for hospitalized cardiac patients which found an effect size of 17% using PHQ-9 scores. Estimated sample sizes for a two-sample proportions test:
Pearson's chi-squared test. Ho: p2 = p1 versus Ha: p2 != p1
Study parameters: alpha = 0.0500, power = 0.8000, delta = -0.1700 (difference), p1 = 0.5100, p2 = 0.3400

Data analysis
In evaluating outcomes, there will be two groups: group 1 – ‘self-directed’; group 2 – ‘supported’. All statistical analyses will be performed on an intention-to-treat (ITT) basis with alpha level set at 0.05. In the case that ITT produces a null finding, it is possible that this is due to participants in the supported group not participating in the additional telephone sessions (that is, not receiving the intended treatment). In order to test that hypothesis, we will then undertake treatment-received (TR) analysis (also called Per Protocol) whereby only those who received the treatment according to the protocol are included. This will enable us to determine whether any differences were obtained between the those who received the ‘self-directed’ treatment and those who received the ‘supported’ treatment. P values below 0.05 will be considered significant for the primary outcome, and P values below 0.01 will be considered significant for secondary outcomes.
Primary outcome measures
Depression, physical activity and healthy diet: As the main outcomes, we will examine differences between groups 1 and 2 in the proportion of patients who were:
1. classified as non-depressed at baseline, post-program and follow-up (according to a PHQ-9 score of less than 6). PHQ-2 and PHQ-4 scores will also be examined as these scores exclude more ‘somatic’ items such as feeling tired, having problems with sleep and appetite which may be confounded by other physical issues.
2. achieving physical activity guidelines of at least 150 minutes of physical activity per week at baseline, post-program and follow-up.
3. achieving healthy dietary guidelines of DQT scores greater than 60% at baseline, post-program and follow-up.


Secondary outcome measures
Smoking rates: Amongst smokers, the proportion of people who have quit smoking will be compared for the two groups.
Change over time in other psychosocial and attitudinal measures: Change over time in scores on the GAD-7, WHO-5, SF-12, self-efficacy and readiness to change behaviours and emotions will be compared between groups 1 and 2 using repeated measures analysis of variance (ANOVA). Multiple regression analysis, with group entered as a potential predictor, will be used to predict patients with greatest improvements in GAD-7, WHO-5, SF-12 and self-efficacy scores, and readiness to change behaviours and emotions.
Assessing program acceptability
Back on Track acceptability: Proportions will be calculated for all items on the program acceptability scale.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/03/2020
Actual
Date of last participant enrolment
Anticipated
1/04/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
294
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304518 0
Charities/Societies/Foundations
Name [1] 304518 0
HCF Research Foundation
Country [1] 304518 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Centre for Heart Health
Address
Suite 8, 75-79 Chetwynd Street
North Melbourne
Vic 3051
PO Box 2137
Royal Melboune Hospital
Vic 3050
Country
Australia
Secondary sponsor category [1] 304788 0
None
Name [1] 304788 0
Address [1] 304788 0
Country [1] 304788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304949 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 304949 0
Ethics committee country [1] 304949 0
Australia
Date submitted for ethics approval [1] 304949 0
15/11/2019
Approval date [1] 304949 0
18/12/2019
Ethics approval number [1] 304949 0
2019-438

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

Contacts
Principal investigator
Name 98738 0
A/Prof Barbara Murphy
Address 98738 0
Australian Centre for Heart Health
Suite 8, 75-79 Chetwynd Street
North Melbourne
Vic 3051
Country 98738 0
Australia
Phone 98738 0
+61 393268544
Fax 98738 0
Email 98738 0
[email protected]
Contact person for public queries
Name 98739 0
Michelle Rogerson
Address 98739 0
Australian Centre for Heart Health
Suite 8, 75-79 Chetwynd Street
North Melbourne
Vic 3051
Country 98739 0
Australia
Phone 98739 0
+61 393268544
Fax 98739 0
Email 98739 0
[email protected]
Contact person for scientific queries
Name 98740 0
Barbara Murphy
Address 98740 0
Australian Centre for Heart Health
Suite 8, 75-79 Chetwynd Street
North Melbourne
Vic 3051
Country 98740 0
Australia
Phone 98740 0
+61 393268544
Fax 98740 0
Email 98740 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6160Study protocol  [email protected]



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.