Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001289707
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
4/10/2022
Date last updated
2/10/2023
Date data sharing statement initially provided
4/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of an enhanced care program on the wellbeing of patients with acute decompensated heart failure: protocol for a randomised controlled trial
Scientific title
Investigating the effect of an enhanced care program on the wellbeing of patients with acute decompensated heart failure: protocol for a randomised controlled trial
Secondary ID [1] 307551 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Decompensated Heart Failure 326990 0
Condition category
Condition code
Cardiovascular 324178 324178 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this group will receive usual care, plus the Enhanced HF Care program. The cardiac nurse and team will explain the program to patients. Participants will receive detailed instructions on how to download Enhanced HF Care and save the link as a shortcut onto their devices. Via the program patients will be prompted to monitor depression and clinical outcomes and offered tailored self-care advice and clinical support, as needed. As a proactive strategy to encourage program use and adherence to recommendations, the nurse will provide patients with a letter from their cardiologist highlighting the importance of these aspects. If specific modules are not completed, prompts will reiterate the importance of completion.

The program will include:
1. Educational modules: A series of short learning units (i.e., micro-learning modules) which contain core information and actions for the post-discharge period will be provided within the program. This includes some of the National Heart Foundation’s existing videos and written resources embedded within a series of short learning units, i.e., micro-learning modules./videos Additional modules have been developed specifically for this study. All patients will be instructed to complete 5 essential modules which contain core information and actions for the post-discharge period: 1) What is Heart failure, 2) Symptoms, 3) Medication; 4) How to manage physical aspects of Heart failure and 5) How to recognise and manage feeling anxious or depressed. Additional modules covering optional areas of interest for patients and support persons will be offered including dietary problems, complementary strategies, accessing additional support and community-based aged care. Each video will be no longer than 5 minutes. Patient understanding will be assessed via brief questions at the end of each module. Participants will be encouraged to share these educational resources with their support person if they have one. Reminders to encourage completion: If modules are not completed, prompts will reiterate the importance of completion. An automated email will be used to reach individuals who do not login to the app within 3 days of recruitment. If the participant has not logged in within 7 days then they will receive a phone call from the research nurse. If microlearning modules have not been completed within 7 days of app download, reminder prompts will be displayed via device notifications and followed by a call from the cardiac nurse.
2. Transfer of care: The cardiologist will email the patients’ GP recommending the patients consult with them in two weeks, post-discharge. The email will provide GPs with access to the micro-learning modules to refresh their knowledge regarding the nature, treatment and outcomes of Acute Decompensated Heart Failure (ADHF).
3. Clinical monitoring of emotional and physical wellbeing: The Enhanced HF Care will allow patients to complete monitoring items, using extensively validated measures including:
• Depression: The Patient Health Questionnaire (PHQ)-2, with those scoring greater than or equal to =3 completing the full survey (PHQ-9).
• Anxiety: The Generalised Anxiety Disorder (GAD)-2, with those scoring greater than or equal to=3 completing the full survey (GAD-7).
• Physical wellbeing: The Kansas City Cardiomyopathy Questionnaire (KCCQ-12).

Patients will be emailed a survey link to complete the monitoring survey fortnightly (expected to take less than five minutes to complete) in the first month, post-discharge. Responses will link in with the Enhanced HF Care program. Thereafter, the frequency of monitoring will increase or decrease dependent upon the patients self-reported indication of emotional and physical wellbeing.

For example, patients who score low risk for depression on both surveys in the first month will change to monthly depression screening thereafter. Patients who indicate a moderate/high risk for depression, in the first screening instance, will be prompted one week later to check whether they have accessed the recommended self-help strategies. Fortnightly surveys will continue until those with moderate/high risk depression indicate a reduction in symptoms.

An algorithm will generate tailored support depending on the clinical monitoring data. For example:
• Step 1. Self-care: For low-level risk, on one occasion or infrequently, evidence-based self-help strategies will be provided to the patient and support person via the program. For example, participants may be encouraged to complete a specific learning module/s.
• Step 2. Cardiac team dashboard notification: Alerts will be sent to the cardiac nurse dashboard. For medium-level risks, the nurse is suggested to review and consider in clinical care plan. For high-level risks, the nurse will follow up with patient and consider whether GP should be notified.
• Step 3. GP notification: The GP will receive an email with the patient’s most recent emotional and physical wellbeing scores, with a recommendation to schedule an appointment within the next two weeks.
Intervention code [1] 324010 0
Treatment: Other
Comparator / control treatment
The usual care group will receive standard care with involvement from cardiology and allied health teams. This includes referral to a heart failure service; a recommendation to make an appointment with their GP 7 days after hospital discharge; and a review with their specialist one month post-discharge.
Control group
Active

Outcomes
Primary outcome [1] 331988 0
Co-primary outcome variables: emotional wellbeing and physical domains. The Minnesota Living with Heart Failure Questionnaire (MLHFQ) will be used. The MLHFQ attains overall health-related quality of life scores with an emotional and physical subscale. A clinically relevant difference is defined as 1.75 points in the MLHFQ emotional domain and 3.5 points in the physical domain at 6-months follow-up.
Timepoint [1] 331988 0
1- and 6-months post-randomisation
Secondary outcome [1] 411846 0
Cost-effectiveness. Medical Record Number data will be used to attribute individual patient costs based on hospital utilisation. A medical record audit will be conducted for each consenting patient via routinely collected health service records via the Medical Record Number. In HNELHD, MRNs attribute costs to individual patients based on services they use. They are particularly accurate for inpatient costs. Any services (e.g., medication, pathology, rehabilitation, other tests) used by a patient are collected by feeder systems and applied to the individual’s MRN. The following information will be collected via records audit: diagnoses; treatment received; whether or not the survivor has been prescribed common pharmacological treatments for heart failure; details of the medication regime; and whether or not the patient been referred to a rehabilitation program. The follow-up surveys will also obtain information not available from hospital records, using a modified version of the Client Services Receipt Inventory.
Timepoint [1] 411846 0
1- and 6-months post-randomisation

Eligibility
Key inclusion criteria
Patients with acute decompensated heart failure (including reduced and preserved ejection fraction) being discharged from participating hospitals into the community; aged 18 years or older; with access to a smart device with internet; and willing to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide written informed consent, have no access to the internet to participate in the intervention or complete the surveys.

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)
Allocation was concealed: central randomisation by computer (REDCap program)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be created with blocks of sizes two and four selected randomly.
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
A baseline sample of 285 participants per group (570 in total) will provide 80% power to detect a clinically significant difference of 1.75 points in the MLHFQ emotional domain and 3.5 points in the physical domain after 6 months, while maintaining an overall type 1 error rate of 5%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
24/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
570
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22797 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 22798 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment postcode(s) [1] 38082 0
2305 - New Lambton
Recruitment postcode(s) [2] 38083 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 311825 0
Charities/Societies/Foundations
Name [1] 311825 0
National Heart Foundation
Country [1] 311825 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 313300 0
Government body
Name [1] 313300 0
Hunter New England Local Health District
Address [1] 313300 0
Lookout Rd, New Lambton NSW 2305
Country [1] 313300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311268 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 311268 0
Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 311268 0
Australia
Date submitted for ethics approval [1] 311268 0
31/03/2022
Approval date [1] 311268 0
13/05/2022
Ethics approval number [1] 311268 0
2022/ETH00502
Ethics committee name [2] 311270 0
The University of Newcastle’s Human Research Ethics Committee
Ethics committee address [2] 311270 0
University Dr, Callaghan NSW 2308
Ethics committee country [2] 311270 0
Australia
Date submitted for ethics approval [2] 311270 0
11/07/2022
Approval date [2] 311270 0
18/07/2022
Ethics approval number [2] 311270 0
H-2022-0227

Summary
Brief summary
Depression is highly prevalent and associated with increased hospitalisation and mortality among patients with heart disease. A whole-person care approach to depression management, encompassing mental wellbeing, behavioural risk factors and treatment adherence, is needed. This study will test whether a wellbeing program for patients discharged with Acute Decompensated Heart Failure (ADHF) improves emotional and physical wellbeing.

A two-arm RCT with participants randomly allocated to intervention (an enhanced community care program for heart failure: “Enhanced HF Care”) or usual care. Eligible patients with ADHF will be recruited prior to discharge from two hospitals. Patients will be provided access to Enhanced HF Care, and via the program, will be prompted to monitor depression and clinical outcomes. Guideline adherent actions for clinically significant depression scores and clinical outcomes will be utilised. Automated parameters within Enhanced HF Care will trigger specific action advice for patients, such as self-care recommendations (via videos or written information). Cardiac nurse specialists will track real-time patient data from a dashboard, and receive automated emails when patients provide high-risk data. Cardiac nurses will prompt cardiologists to action, where needed. General practitioners will receive automated emails for patients reporting high levels of depression and encouraged to schedule a patient consultation.

Outcomes will be assessed at one and six-months via brief measures for Quality of Life. Intervention participants will also complete brief weekly/fortnightly measures for depression via the program. Healthcare utilization will be examined via patient self-report and hospital admission data.
The primary analysis population will be the intention to treat, defined as all randomised participants. The co-primary outcome variables will be compared between treatment arms using separate linear mixed effects regression models.

This study has the potential to reduce the burden of depression for patients following ADHF. This novel process will prioritise urgent patient mental health needs while empowering the patient with self-care knowledge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120514 0
Prof Andrew Boyle
Address 120514 0
John Hunter Hospital, Cardiology Department, Locked Bag No 1, Newcastle Region Mail Centre, New Lambton Heights NSW 2305
Country 120514 0
Australia
Phone 120514 0
+612 4921 4205
Fax 120514 0
Email 120514 0
andrew.boyle@newcastle.edu.au
Contact person for public queries
Name 120515 0
Prof Andrew Boyle
Address 120515 0
John Hunter Hospital, Cardiology Department, Locked Bag No 1, Newcastle Region Mail Centre, New Lambton Heights NSW 2305
Country 120515 0
Australia
Phone 120515 0
+612 4921 4205
Fax 120515 0
Email 120515 0
Andrew.Boyle@health.nsw.gov.au
Contact person for scientific queries
Name 120516 0
Dr Kristy Fakes
Address 120516 0
University of Newcastle/ Hunter Medical Research Institute, Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305
Country 120516 0
Australia
Phone 120516 0
+612 4042 0306
Fax 120516 0
Email 120516 0
kristy.fakes@newcastle.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 from this study are not publicly available because of ethical restrictions on data sharing due to the need to protect patient confidentiality. Under the terms of our approval, it is required that access to data is restricted to study personnel only.


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.