None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Exclusion criteria
Unable to provide written informed consent, have no access to the internet to participate in the intervention or complete the surveys.