Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001069741p
Ethics application status
Not yet submitted
Date submitted
22/06/2022
Date registered
2/08/2022
Date last updated
2/08/2022
Date data sharing statement initially provided
2/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Cardiac Prehabilitation on Clinical Outcomes: A comparison between Surgical Aortic Valve Replacement (sAVR) and Transcatheter Aortic Valve Implantation (TAVI).
Scientific title
The Impact of Cardiac Prehabilitation on Clinical Mental Health Outcomes: A comparison between Surgical Aortic Valve Replacement (sAVR) and Transcatheter Aortic Valve Implantation (TAVI).
Secondary ID [1] 307412 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic stenosis 326747 0
Depression 326748 0
Anxiety 326757 0
Surgical Aortic Valve Replacement 326758 0
Transcatheter Aortic Valve Implantation 326962 0
Condition category
Condition code
Cardiovascular 323976 323976 0 0
Other cardiovascular diseases
Mental Health 323977 323977 0 0
Depression
Surgery 323978 323978 0 0
Other surgery
Mental Health 324143 324143 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to investigate the effectiveness of preoperative psychological interventions for in patients awaiting sAVR and TAVI surgery.
Patients will undergo a four online (telehealth) sessions of psychocardiac prehabilitation delivered by a clinical/health psychologist, where they will be provided with psychoeducation regarding their procedure and likely emotional responses, basics of cognitive behaviour therapy and mindfulness as well as relaxation exercises.
Each session will be for 1 hour and it will take place once a week for four weeks.
the treatment approach will follow a procedure consisting of 4 basic stages: cognitive preparation, skill acquisition, rehearsal, and application practice. Session 1 will cover psychoeducation about their condition and the proposed links between mental stress and heart disease, session two will cover mindfulness training with a focus on compassion aimed at improving self control, session three will involve the therapist and client working through the use of the mindfulness intervention and session four will cover application of the intervention technique in different settings and situations.
Participants will be provided with specific study designed information handouts for each session.
Participants undergoing both sAVR and TAVI will log into their sessions with the psychologist, just as logging into a telehealth session with their health provider. The sessions will be over a safe cloud communication and collaboration product such as Ring Central or MS Teams.
The Prehabilitation sessions will take place in the 4 weeks prior to surgery with the last session scheduled on the week of surgery. Both groups will receive the same intervention.
Participants will be monitored for attendance during intervention and followed up after surgery and at six months post surgery
Intervention code [1] 323849 0
Treatment: Other
Intervention code [2] 323854 0
Behaviour
Intervention code [3] 323855 0
Prevention
Comparator / control treatment
There will be two comparison groups, one for sAVR and another for TAVI. These groups will be comprised of individuals on each of the two cardiac surgery waitlists who have not received the prehabilitation intervention and will not receive the intervention at any point,
Control group
Active

Outcomes
Primary outcome [1] 331776 0
Depression assessed using the Patient Health Questionnaire (PHQ)-9
Timepoint [1] 331776 0

Primary timepoint: 4 weeks pre surgery (baseline measures)
Second timepoint: 48 hours after surgery (post surgery)
Third timepoint: 6 months post surgery (follow up)
Primary outcome [2] 331788 0
Anxiety assessed using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 331788 0
Primary timepoint: 4 weeks pre surgery (baseline measures)
Second timepoint: 48 hours after surgery (post surgery)
Third timepoint: 6 months post surgery (follow up)
Secondary outcome [1] 411092 0
Quality of life assessed using the WHO Quality of Life (WHOQOL) questionnaire
Timepoint [1] 411092 0
4 weeks pre surgery (baseline measures)
48 hours after surgery (post surgery)
6 months post surgery (follow up)
Secondary outcome [2] 411879 0
Cardiac distress assessed using the cardiac distress (CDS) scale (Jackson et al., 2022)
Timepoint [2] 411879 0
4 weeks pre surgery (baseline measures)
48 hours after surgery (post surgery)
6 months post surgery (follow up)
Secondary outcome [3] 411880 0
Cardiac rehabilitation uptake will be measured by comparing to usual care through reviewing patient cardiac rehabilitation attendance lists.
Timepoint [3] 411880 0
4 weeks pre surgery (baseline measures)
48 hours after surgery (post surgery)
: 6 months post surgery (follow up)

Eligibility
Key inclusion criteria
Patients awaiting sAVR or TAVI
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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation with computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer
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
This study is a prospective, randomized, controlled, assessor blinded, single-center trial with four arms, including two experimental arms and control arms (patients undergoing usual treatment).
Descriptive statistics will be used to describe the sample characteristics and outcome measures such as cardiac rehabilitation uptake. Changes in pre-, post-, and 6-month measures of PHQ-9, HADS, WHOQOL, Distress tolerance will be measured using the Jackson et al (2022) Cardiac Distress Questionnaire.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/01/2023
Actual
Date of last participant enrolment
Anticipated
12/12/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22600 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 37859 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 311688 0
Self funded/Unfunded
Name [1] 311688 0
Country [1] 311688 0
Primary sponsor type
University
Name
Federation University Australia
Address
Federation University Australia
Office 1 Building 901 Berwick Campus
100 Clyde Road Berwick VIC 3806
Country
Australia
Secondary sponsor category [1] 313144 0
None
Name [1] 313144 0
Address [1] 313144 0
Country [1] 313144 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311142 0
Monash Health Ethics Committee
Ethics committee address [1] 311142 0
Monash Medical Centre
Clayton Road
Clayton VIC 3168
Ethics committee country [1] 311142 0
Australia
Date submitted for ethics approval [1] 311142 0
28/10/2022
Approval date [1] 311142 0
Ethics approval number [1] 311142 0

Summary
Brief summary
The major aim of this project is to test the effectiveness of Cardiac Prehabilitation aimed at reducing anxiety, depression and distress in patients with aortic stenosis undergoing either sAVR or TAVI as cardiac interventions. This will be assessed by comparing each group against their control arm of cardiac patients in the surgery waitlist.
In addition, we will examine whether prehabilitation has been more effective in either sAVR or TAVI. It is expected that those undergoing sAVR will demonstrate higher rates of baseline psychological distress than those undergoing TAVI.
A secondary aim is to gauge whether undertaking a web-based intervention has resulted in higher rates of cardiac rehabilitation uptake than is usually seen in this population. This research will contribute to the current lack of research in the area of early interventions in cardiac patients with aortic stenosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120090 0
Dr Marlies Alvarenga
Address 120090 0
Federation University Australia
Office 1, Building 901, Berwick Campus
100 Clyde Road Berwick VIC 3806
Country 120090 0
Australia
Phone 120090 0
+61 343137912
Fax 120090 0
Email 120090 0
m.alvarenga@federation.edu.au
Contact person for public queries
Name 120091 0
Dr Marlies Alvarenga
Address 120091 0
Federation University Australia
Office 1, Building 901, Berwick Campus
100 Clyde Road Berwick VIC 3806
Country 120091 0
Australia
Phone 120091 0
+61 343137912
Fax 120091 0
Email 120091 0
m.alvarenga@federation.edu.au
Contact person for scientific queries
Name 120092 0
Dr Marlies Alvarenga
Address 120092 0
Federation University Australia
Office 1, Building 901, Berwick Campus
100 Clyde Road Berwick VIC 3806
Country 120092 0
Australia
Phone 120092 0
+61 343137912
Fax 120092 0
Email 120092 0
m.alvarenga@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be collected and analysed in aggregate. It will be released only in publications. Individual data will not be made available


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.