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Trial registered on ANZCTR


Registration number
ACTRN12616001333404
Ethics application status
Approved
Date submitted
29/06/2016
Date registered
26/09/2016
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
PAIR of Hearts Study (Palliative care Approach, Investigating Real outcomes in Heart failure)
Scientific title
The effects of early initiation of discussions regarding a palliative care approach with adults with moderate to severe non-valvular heart failure on quality of life and depressive symptoms.
Secondary ID [1] 289501 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PAIR of Hearts Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 299199 0
Condition category
Condition code
Cardiovascular 299207 299207 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention = Early initiation of discussions regarding a palliative approach to care.

Intervention Procedures = The early initiation of a palliative approach to care will involve the addition of sensitive discussions with participants and their nominated close associates on themes of prognosis, disease trajectory, palliative care, doctor-patient relationships and advanced care directives, in addition to standard care. This intervention will occur immediately post study randomisation into the intervention arm of the study independent of time since diagnosis.

Intervention Materials = Discussions will be guided using Intervention Checklists and written patient information booklets will be provided to participants.

Mode of delivery and location of intervention = 1x face-to-face session at Sir Charles Gairdner Hospital which will require attendance at the clinic for approximately 1 hour and 30 minutes (this will include time for the completion of paperwork and questionnaires and for the interventional discussion of duration = 45 minutes) and 1x follow-up phone call at 1 month after initial face-to-face session of duration no greater than 15 minutes.

Who will deliver intervention = The intervention will be delivered by a member of the study team. This will be a medical student who has completed palliative care on-line training modules, a doctor or a nurse.

How intervention is personalised or adapted = As occurs in real-life settings participants will be first asked for consent before discussing any topics.
Intervention code [1] 295107 0
Treatment: Other
Comparator / control treatment
Standard care alone.

In this study standard care is defined as the usual standard of care being offered to patients with heart failure at Sir Charles Gairdner Hospital. This involves being under the care of a treating cardiologist, attending clinic appointments booked at the discretion of the treating cardiologist, hospital admissions when required, usual access to allied health services, management by the Cardiac Rehabilitation and Heart Failure service and usual utilisation of General Practice care. Standard care does not exclude involvement in formalised palliative care if requested by patients or their usual treating team. However, involvement in such a service will be recorded for study results discussion.

Participants receiving standard care alone will not be offered the intervention discussion as part of the study, but will not be discouraged from having discussions on similar topics with their usual health care team.
Control group
Active

Outcomes
Primary outcome [1] 298781 0
To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and improved quality of life as shown by % of patients with a 10 point decrease in the FACIT-Pal (version 4) questionnaire score.
Timepoint [1] 298781 0
2 months post initial intervention.
Primary outcome [2] 298782 0
To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and increase in depressive symptoms as shown by % of patients with a 2 point increase in the Patient Health Questionnaire 9 (PHQ-9) score.
Timepoint [2] 298782 0
2 months post initial intervention.
Secondary outcome [1] 325183 0
To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and improved overall wellness rating as reported by the patient on a Visual Analogue Scale from 0 to 10.
Timepoint [1] 325183 0
2 months post initial intervention.
Secondary outcome [2] 325184 0
To determine if there is any statistically significant difference between patient self-reported overall wellness rating and overall wellness rating by the patient’s close associate at initial assessment as reported on a Visual Analogue Scale from 0 to 10.
Timepoint [2] 325184 0
Measured on the day of randomisation prior to initial intervention,
Secondary outcome [3] 325185 0
To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and a reduction in any difference between patient self-reported overall wellness rating and overall wellness rating by the patient’s close associate on a Visual Analogue Scale from 0 to 10.
Timepoint [3] 325185 0
2 months post initial intervention.
Secondary outcome [4] 327812 0
To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and improved quality of life as shown by % of patients with a 10 point decrease in the FACIT-Pal (version 4) questionnaire score.
Timepoint [4] 327812 0
4 months post initial intervention
Secondary outcome [5] 327813 0
To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and increase in depressive symptoms as shown by % of patients with a 2 point increase in the Patient Health Questionnaire 9 (PHQ-9) score.
Timepoint [5] 327813 0
4 months post initial intervention

Eligibility
Key inclusion criteria
The study will enrol men and women greater than or equal to 18 years old who are under the care of the Cardiovascular Medicine Department, at Sir Charles Gairdner Hospital, Perth WA, with a diagnosis or past diagnosis of chronic non-valvular heart failure of NYHA classification III or IV.
Close associates nominated by patients will also be invited to be involved in the study (these close associates may be healthy volunteers and must be greater than or equal to 18 years old).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with heart failure that is known to be highly likely to be reversible (e.g. valvulopathy with planned correction via valvular surgery in an appropriate surgical candidate)
* Patients with current diagnosis of psychiatric illness
* Patients with other major illnesses that may require palliative care such as cancer
* Patients or close associates who have insufficient verbal, reading and written English language capability to provide full informed consent for study participation
* Patients or close associates with possible cognitive impairment likely to interfere with comprehension and the informed consent procedure
* Patients or close associates without telephone access or means to be contacted via phone
* Patients already receiving specialised palliative care services prior to study enrolment
* Close associates of the patient who are not nominated to be involved by the patient themselves

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)
Randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 90 patients is required to have an 80% chance of detecting an increase in the primary outcome measure of 10 points of difference in the FACIT-Pal questionnaire for quality of life with statistical significance at the 5% level. This is a pilot study in patients with heart failure so sample size has been approximated from a study in patients with cancer. This calculation of sample size was based on a standard deviation of 16.74 which was the mean standard deviation of the two groups in a study by Bakitas and colleagues 10 which used the FACIT-Pal questionnaire to evaluate quality of life in oncology patients. The calculation was made using the Power (Sample Size) Calculator for Continuous outcome superiority trials provided online by Sealed Envelope Ltd (https://www.sealedenvelope.com/power/continuous-superiority/).

Analyses will be conducted using IBM SPSS Statistics version 22. Baseline variables will be analysed to assess adequacy of randomisation. Continuous variables will be assessed by ANOVA. Categorical variables will be compared by Chi-square for proportions and logistic regression. Non-parametric analyses will be used where appropriate for small samples or non-normally distributed data. Subject data will be assessed on an as randomised basis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/09/2016
Actual
28/11/2016
Date of last participant enrolment
Anticipated
2/02/2021
Actual
Date of last data collection
Anticipated
2/09/2021
Actual
Sample size
Target
90
Accrual to date
55
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6034 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 13483 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 293941 0
Hospital
Name [1] 293941 0
QEII
Country [1] 293941 0
Australia
Primary sponsor type
Individual
Name
A/Prof Brendan McQuillan
Address
L2 Harry Perkins Building
QQ Block
QEII Medical Centre
6 Verdun St
NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 292764 0
None
Name [1] 292764 0
Address [1] 292764 0
Country [1] 292764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295354 0
Sir Charles Gairdner Hospital HREC
Ethics committee address [1] 295354 0
Ethics committee country [1] 295354 0
Australia
Date submitted for ethics approval [1] 295354 0
23/05/2016
Approval date [1] 295354 0
07/10/2016
Ethics approval number [1] 295354 0
2016-032

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

Contacts
Principal investigator
Name 66794 0
A/Prof Brendan McQuillan
Address 66794 0
L2 Harry Perkins Building
QQ Block
QEII Medical Centre
6 Verdun St
NEDLANDS WA 6009
Country 66794 0
Australia
Phone 66794 0
+61 (08) 93463333
Fax 66794 0
Email 66794 0
brendan.mcquillan@uwa.edu.au
Contact person for public queries
Name 66795 0
Brendan McQuillan
Address 66795 0
L2 Harry Perkins Building
QQ Block
QEII Medical Centre
6 Verdun St
NEDLANDS WA 6009
Country 66795 0
Australia
Phone 66795 0
+61 (08) 93463333
Fax 66795 0
Email 66795 0
brendan.mcquillan@uwa.edu.au
Contact person for scientific queries
Name 66796 0
Brendan McQuillan
Address 66796 0
L2 Harry Perkins Building
QQ Block
QEII Medical Centre
6 Verdun St
NEDLANDS WA 6009
Country 66796 0
Australia
Phone 66796 0
+61 (08) 93463333
Fax 66796 0
Email 66796 0
brendan.mcquillan@uwa.edu.au

No information has been provided regarding IPD availability


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.