Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000386538
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
3/04/2024
Date last updated
26/08/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Heart2Heart: Implementation of a peer support program for people with heart disease
Scientific title
Heart2Heart: Implementation of a peer support program for people with heart disease: a community-based, investigator-blinded randomised controlled trial
Secondary ID [1] 311572 0
None
Universal Trial Number (UTN)
Trial acronym
Heart2Heart
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 329524 0
Condition category
Condition code
Cardiovascular 326462 326462 0 0
Coronary heart disease
Cardiovascular 331448 331448 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will have access to a 6-month intervention that enables peer support via an interactive mobile application (app). Participants will be able to access the app down download from their personal mobile device. The intervention includes online peer discussion groups via discussion board (e.g., exercise and diet) in the app, access to digital educational resources (web-based information such as text, images, and videos), and facilitated conversations with health professionals (e.g., cardiac nurse, physiotherapist, dietician etc.). All participants will have access to all discussions and groups within the CVD community. Health professionals will be joining into the discussion groups periodically, post educational resources, as well as facilitate conversations with participants. The facilitated discussions will be online and likely less than a few minutes in duration on each occasion, however duration will vary and will be generic in nature with anything substantial in medical information requirements, the participants will be encouraged to discuss more fully with their general practitioners or other personal health provider. There will be no specific number of times per week required, however, participant will be encouraged to use the app as many times as they want. Adherence and engagement with the app will be monitored through analytic report provided by the app company (e.g., user session time, login tracker, engagement etc.).
Intervention code [1] 327915 0
Rehabilitation
Comparator / control treatment
Standard care for cardiovascular health as determined by treating doctors.
Control group
Active

Outcomes
Primary outcome [1] 337291 0
Social connectedness measured using self-report
Timepoint [1] 337291 0
6 months after starting the intervention.
Secondary outcome [1] 431355 0
Number of cardiovascular disease (CVD) hospital admissions (self-reported via study-specific questionnaire).
Timepoint [1] 431355 0
6 months after starting the intervention.
Secondary outcome [2] 431907 0
Number of CVD hospitalisations (self-reported via study-specific questionnaire).
Timepoint [2] 431907 0
12 months after starting the intervention.
Secondary outcome [3] 431908 0
Number of deaths (all-cause) from National Death Index (NDI) database.
Timepoint [3] 431908 0
6 months after starting the intervention.
Secondary outcome [4] 431909 0
Number of deaths (all-cause) from National Death Index (NDI) database.
Timepoint [4] 431909 0
12 months after starting the intervention.
Secondary outcome [5] 431910 0
Social connectedness – 8-item Social Connectedness Scale
Timepoint [5] 431910 0
6 months after starting the intervention.
Secondary outcome [6] 431911 0
Social connectedness – 8-item Social Connectedness Scale
Timepoint [6] 431911 0
12 months after starting the intervention.
Secondary outcome [7] 431912 0
Proportion physically inactive (Global Physical Activity Questionnaire)
Timepoint [7] 431912 0
6 months after starting the intervention.
Secondary outcome [8] 431913 0
Proportion physically inactive (Global Physical Activity Questionnaire)
Timepoint [8] 431913 0
12 months after starting the intervention.
Secondary outcome [9] 431914 0
Point abstinence from smoking (self-report)
Timepoint [9] 431914 0
6 months after starting the intervention.
Secondary outcome [10] 431915 0
Point abstinence from smoking (self-report)
Timepoint [10] 431915 0
12 months after starting the intervention.
Secondary outcome [11] 431916 0
Proportion consuming alcohol one or more standard drinks per week (self report)
Timepoint [11] 431916 0
6 months after starting the intervention.
Secondary outcome [12] 431917 0
Proportion consuming alcohol one or more standard drinks per week (self report)
Timepoint [12] 431917 0
12 months after starting the intervention.
Secondary outcome [13] 431918 0
Proportion meeting fruits and vegetable guidelines (self-report)
Timepoint [13] 431918 0
6 months after starting the intervention.
Secondary outcome [14] 431919 0
Proportion meeting fruits and vegetable guidelines (self-report)
Timepoint [14] 431919 0
12 months after starting the intervention.
Secondary outcome [15] 431920 0
Proportion of days covered with guideline-recommended medications (Pharmaceutical Benefits Scheme administrative data)
Timepoint [15] 431920 0
6 months after starting the intervention.
Secondary outcome [16] 431921 0
Proportion of days covered with guideline-recommended medications (Pharmaceutical Benefits Scheme administrative data)
Timepoint [16] 431921 0
12 months after starting the intervention.
Secondary outcome [17] 431922 0
Participation in cardiac rehabilitation program (self-reported via study-specific questionnaire).
Timepoint [17] 431922 0
6 months after starting the intervention.
Secondary outcome [18] 431923 0
Self-efficacy (Self-Efficacy to Manage Chronic Disease Scale)
Timepoint [18] 431923 0
6 months after starting the intervention.
Secondary outcome [19] 431924 0
Self-efficacy (Self-Efficacy to Manage Chronic Disease Scale)
Timepoint [19] 431924 0
12 months after starting the intervention.
Secondary outcome [20] 431925 0
Quality of life (EQ5D-5L)
Timepoint [20] 431925 0
6 months after starting the intervention.
Secondary outcome [21] 431926 0
Quality of life (EQ5D-5L)
Timepoint [21] 431926 0
12 months after starting the intervention.

Eligibility
Key inclusion criteria
(i) aged at least 18 years; (ii) have confirmed diagnosis of heart disease; and iii) own an active mobile device.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) major neurocognitive diagnoses; (ii) not willing/able to give informed consent; and (iii) are unable to read or speak English; and (iv) severe heart failure (NYHA class III or IV).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation sequence will be concealed. An independent statistician will generate the randomisation schedule by computer (then upload into the study REDCap) with allocation sequence concealment strategies implemented. Lead investigator, participants, statisticians, and research assistants collecting data will be blinded to the order of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random allocation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be performed according to the intention-to-treat principle by a statistician blinded to group allocation. Baseline and outcome data will be presented as frequencies and proportions for categorical data, and means and standard deviations (SD) for normally distributed continuous outcomes or median and interquartile intervals for skewed continuous outcomes. Outcomes will be compared between control and intervention groups using all available data with intervention and control groups compared at 6 and 12 months. Normally distributed continuous outcomes will be analysed using the analysis of covariance (ANCOVA) and categorical outcomes will be compared using a log-binomial regression model, adjusting for baseline value of the outcome variable. Pre-specified sub-group analyses will be performed for (i) gender, (ii) reginal areas, (iii) cardiac rehabilitation completion versus not and (iv) previous or current peer support attendance versus not. The subgroups will be compared by including an interaction term between the subgroups and the randomisation status to the main models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
2/06/2024
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
752
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 26143 0
Westmead Hospital - Westmead
Recruitment hospital [2] 26144 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42002 0
2145 - Westmead
Recruitment postcode(s) [2] 42003 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 313491 0
Government body
Name [1] 313491 0
National Health and Medical Research Council: Medical Research Future Fund - 2020 Cardiovascular Health Grant [MRF2007669]
Country [1] 313491 0
Australia
Funding source category [2] 315747 0
Government body
Name [2] 315747 0
National Health and Medical Research Council: Synergy Grant [GNT1182301].
Country [2] 315747 0
Australia
Funding source category [3] 315875 0
Government body
Name [3] 315875 0
NSW Health: 2020 Cardiovascular Senior Researcher Grant: [G212792].
Country [3] 315875 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 317861 0
None
Name [1] 317861 0
Address [1] 317861 0
Country [1] 317861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312678 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312678 0
Ethics committee country [1] 312678 0
Australia
Date submitted for ethics approval [1] 312678 0
24/05/2023
Approval date [1] 312678 0
12/06/2023
Ethics approval number [1] 312678 0
2023/ETH00318

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

Contacts
Principal investigator
Name 125534 0
Prof Julie Redfern
Address 125534 0
School of Health Sciences The University of Sydney, Camperdown NSW 2006
Country 125534 0
Australia
Phone 125534 0
+61 2 8627 0279
Fax 125534 0
Email 125534 0
[email protected]
Contact person for public queries
Name 125535 0
Emily Li
Address 125535 0
School of Health Sciences The University of Sydney, Camperdown NSW 2006
Country 125535 0
Australia
Phone 125535 0
+61 2 8627 0279
Fax 125535 0
Email 125535 0
[email protected]
Contact person for scientific queries
Name 125536 0
Julie Redfern
Address 125536 0
School of Health Sciences The University of Sydney, Camperdown NSW 2006
Country 125536 0
Australia
Phone 125536 0
+61 2 8627 0279
Fax 125536 0
Email 125536 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?

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.