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PAIR of Hearts Study (Palliative care Approach, Investigating Real outcomes in Heart failure)

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001333404
Acronym
PAIR of Hearts Study
Enrollment
55
Registered
2016-09-26
Start date
2016-11-28
Completion date
2021-02-02
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this pilot study is to determine how different information discussed with, or given to, people suffering with heart failure might affect their quality of life, mood and overall well-being. Studies in this area of research may improve our understanding of how best to provide information and a palliative approach to care patients for with heart failure.

Interventions

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 = 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.

Sponsors

A/Prof Brendan McQuillan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026