Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000411448
Ethics application status
Approved
Date submitted
1/12/2023
Date registered
6/05/2025
Date last updated
6/05/2025
Date data sharing statement initially provided
6/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of a nurse-led structured automated telephone support intervention on adherence to self-management for patients with heart failure: the Fairfield Adherence Study
Scientific title
Investigating the impact of a nurse-led structured automated telephone support intervention on adherence to self-management for patients with heart failure: the Fairfield Adherence Study
Secondary ID [1] 311077 0
None
Universal Trial Number (UTN)
U1111-1301-1065
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 332222 0
Condition category
Condition code
Cardiovascular 328938 328938 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients recruited will be those eligible to receive ongoing care in the community through the Fairfield Heart Failure Service following discharge from Fairfield Hospital for a cardiac admission and referral to the heart failure (HF) Service. Patients are initially contacted by a member of the HF Service within 1-2 weeks of their discharge from Fairfield Hospital. After eligibility for the Fairfield HF Service has been established and the patient consents to receive the service, the HF nurse arranges an initial home visit at a mutually convenient time. During this home visit the HF nurse conducts a comprehensive assessment of the patient and their clinical, educational and psycho-social situation and needs. This initial assessment usually takes 1-1.5 hrs. A plan of care will be established, mapping how these needs will be addressed and met. This will include provision of HF self-care education. A maintenance and monitoring program will be agreed, whereby there will be telephone or home visit contact usually from a nurse on an agreed frequency, tailored on an ongoing basis to the patient’s needs at the time.

For patients allocated to receive the intervention of this study, this ongoing contact will derive from telephone calls to the participant's personal number (landline or mobile) of a conversational robot program primed with scripted content comprised of monitoring questions intended to differentiate patients who are currently effectively self-managing their HF from those who need more detailed assessment and/ or some form of clinical input - an automated structured telephone support program (ASTS program) . Questions have been designed so that, if the patient is experiencing a problem with self-management, their responses will flag this. Monitoring questions include asking:
* Have you weighed yourself in the last 3 days?
* Since we last talked, have you been able to stick to your prescribed fluid restriction?
* Since we last talked, have you been able to stick to your prescribed salt restriction?
* Since we last talked, have you experienced any difficulty breathing or shortness of breath?
* How many pillows do you currently use at night?
Have you increased or reduced the number of pillows you use recently?
What change did you make, and when?
* Since we last talked, have you experienced any episodes of fast or irregular heart rate or palpitations?
* Have you experienced any chest pain?
* Since we last talked, have you experienced any swelling in your ankles or legs?
* In the last week, has there been any changes to the medications you are taking or any missed doses?
These include flagging questions which trigger alerts to the HF Service staff. Prompts follow each question, designed to tease out salient details in relation to responses.

The anticipated timing of the first telephone contact is within 1-2 weeks of the assessment home visit and it is anticipated that, whilst the frequency of initial telephone contacts is a clinical decision to be made, and if necessary revised, by the HF Service staff, phone contacts will predominantly occur weekly and be continued for a period of three months.

The ASTS program follows a routine whereby the patient first receives an SMS to their mobile phone alerting them to a phone call in 15 min time. If the patient does not answer this call, a second call will be initiated 5 hrs after the first. If the patient does not answer this, a third call will follow 24 hrs later. If the patient does not answer this, a second SMS will alert the patient that they have missed 3 calls. All calls will be initiated between 9am - 5pm, Monday to Friday. They will then have a period of 2 days to initiate a response call to the sending number.

Programmed telephone responses will be monitored by HF Service staff and, where indicated, followed up by the HF Clinical Nurse Specialist (CNS) with a phone call/ home visit as required.
The scripted content has been developed based on the questions included in local nurses’ routine monitoring phone conversations, previous experience locally using similar programs for home monitoring of chronic obstructive airways disease patients and other patient groups (Chow et al., 2023; Chow et al., 2018; Chow et al., 2019), discussions with local consumers and examples from published studies such as Angermann et al. (2012), Baker et al. (2005) and Barth (2001). The draft program was discussed and piloted in consultation with community-living consumers with HF. These conversations will be audio-recorded so that Fairfield Heart Failure clinical staff can review them.

As for routine care, the frequency of contact will be determined as part of the initial plan of care, and reviewed / revised on an ongoing basis in light of telephone responses to questions.

As for routine care, patients will have a telephone number for the Fairfield Heart Failure Service, so they will be able to make contact with a healthcare professional if they need to talk to someone, have unanswered questions or a problem that they have not been able to raise in a regular contact.

Adherence to the ASTS program will be monitored through the program, in terms of calls answered, responding to questions, call frequency and duration.

The program is maintained on a software platform property of 'Curious Thing, AI Contact Automation' which provides a portal for the research and clinical team members to login to view details of each call and of the progress of the intervention as a whole.
Intervention code [1] 327526 0
Behaviour
Comparator / control treatment
For the control arm, care will be delivered as routine for the Fairfield HF Service.

The maintenance and monitoring program will be agreed, whereby a HF nurse will make telephone contact or conduct a home visit on an agreed frequency, tailored on an ongoing basis to the patient’s needs at the time. This follow-up might occur weekly, fortnightly or monthly and is continuously reviewed, modified or escalated, for example, to include a home visit in response to perceived needs. The patient continues in this monitoring program until there is agreement between the clinical team and patient/ carer that any significant risk factors for preventable hospitalisation have been managed and the patient’s condition stabilised, or they are referred to end of life care; or they wish to leave the program. Once risk factors for preventable hospitalisation and clinical instability have been addressed, the patient is transitioned to primary care management.

All activities delivered by clinical staff for both intervention and comparator group patients will be logged in the health provider organisation's clinical health record system, in line with current clinical practice. This will include time taken by clinicians making patient-related phone calls, home visits, referrals and contacts to other healthcare professionals. Every activity, who undertook it, duration of time required, and pharmaceuticals/ consumables/ equipment used will be extracted and collated at project end.
Control group
Active

Outcomes
Primary outcome [1] 336736 0
HF patients’ acceptance and experience with an ASTS program intervention when delivered as an accompaniment to routine standard care.
Timepoint [1] 336736 0
Primary outcome data will be collected at 3 months post randomisation.
Secondary outcome [1] 429520 0
Secondary outcome 1 comprises self-care of Heart Failure.
Timepoint [1] 429520 0
The survey will be delivered to intervention and comparator groups patients: 1) at baseline (T0) following recruitment to the study but prior to randomisation, and 2) at T1, 3 months after randomisation.
Secondary outcome [2] 447094 0
Secondary outcome 4 comprises costs to the acute service provider of post-discharge care for HF patients, These include: a) costs of the ASTS program intervention in addition to routine care versus b) routine care alone.
Timepoint [2] 447094 0
Secondary outcome 4 data will be collected once all T1 primary and other secondary outcome data have been collected from participants.
Secondary outcome [3] 429522 0
Secondary outcome 2 comprises medication adherence.
Timepoint [3] 429522 0
The survey will be delivered to intervention and comparator groups patients: 1) at baseline (T0) following recruitment to the study but prior to randomisation, and 2) at T1, 3 months after randomisation.
Secondary outcome [4] 447092 0
Secondary outcome 3 comprises patient outcomes in the form of quality of life.
Timepoint [4] 447092 0
Secondary outcome 3 will be collected using a validated instrument delivered with secondary outcomes 1 and 2 as a single survey at 2 time points (i.e. the survey will be delivered at T0 and T1).

Eligibility
Key inclusion criteria
Inclusion criteria for project participation include:
• Male and female patients with a diagnosis of heart failure of any aetiology,
• Patients who are resident in a private home (i.e. not an institutional home),
• Patients deemed eligible for and consenting to receive the Fairfield Hospital Heart Failure service, and newly added to the HF CNS caseload,
• Adult patients, i.e. aged 18 years and above,
• Sufficient spoken/ understanding of the English language to participate (a pragmatic decision for a pilot study not funded to include interpreter costs),
• Patients who own a mobile phone, and have adequate hearing to manage a telephone conversation (with or without hearing aids),
• A diagnosis of HF classified at NYHA Classes I, II and III (i.e. asymptomatic, mildly or moderately symptomatic),
• Willing to give written or oral informed consent to participate and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
• Patients who live in a residential aged care facility or other institutional home,
• Patients with a history of mental illness or any condition such as to interfere with their ability to understand and comply with the requirements of the study.

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)
Allocations will be sealed in numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An MS Office Excel spreadsheet will be used to generate a list of random numbers which will be used to randomise patients eligible for study recruitment to intervention and control groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This pilot study is designed to provide data to inform development and sample size calculation for a future definitive trial. As a pilot study, simple descriptive and comparative statistics will characterise and compare the intervention and control groups, groups’ outcome data at T0 and T1, and changes in within-group outcome data between these time points.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/05/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
14/04/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315334 0
Charities/Societies/Foundations
Name [1] 315334 0
Narellan Rotary
Country [1] 315334 0
Australia
Primary sponsor type
Government body
Name
South West Sydney Local Health District
Address
Liverpool, NSW
Country
Australia
Secondary sponsor category [1] 317402 0
None
Name [1] 317402 0
Address [1] 317402 0
Country [1] 317402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314257 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314257 0
Ethics committee country [1] 314257 0
Australia
Date submitted for ethics approval [1] 314257 0
11/12/2023
Approval date [1] 314257 0
18/03/2024
Ethics approval number [1] 314257 0
2024/STE00579

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

Contacts
Principal investigator
Name 130954 0
Prof Josephine Chow
Address 130954 0
Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool NSW 2170
Country 130954 0
Australia
Phone 130954 0
+61 2 8738 9359
Fax 130954 0
Email 130954 0
[email protected]
Contact person for public queries
Name 130955 0
Josephine Chow
Address 130955 0
Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool NSW 2170
Country 130955 0
Australia
Phone 130955 0
+61 2 8738 9359
Fax 130955 0
Email 130955 0
[email protected]
Contact person for scientific queries
Name 130956 0
Josephine Chow
Address 130956 0
Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool NSW 2170
Country 130956 0
Australia
Phone 130956 0
+61 2 8738 9359
Fax 130956 0
Email 130956 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Pilot study / pilot data only; future definitive trial planned so not appropriate to make data and documents available at this stage.



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.