ODYSSEE-vCHAT Pilot Trial for Chronic Heart Failure

  • STATUS
    Recruiting
  • End date
    Oct 3, 2023
  • participants needed
    162
  • sponsor
    University Health Network, Toronto
Updated on 6 October 2021

Summary

INTRODUCTION

Psychological distress and reduced quality of life are prevalent in patients with chronic heart failure (CHF). The one-year rehospitalization rate is very high (40%), as well as the five-year mortality rates (45% for women and 60% for men). International task force committees report that medical therapy combined with digital (telehealth) counseling for CHF self-care optimizes clinical outcomes.

HYPOTHESES

At trial completion, it is predicted that ODYSSEE-vCHAT versus enhanced usual care (eUC) will reduce hospitalization and mortality. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 2, 4, 6, 10, and 12 and trial completion.

RECRUITMENT

Patients with CHF who are at least 18 years old are recruited. Accrual of the sample (n = 162) will occur over an 18-month period. It involves the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and community-based patients.

DESIGN

ODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 2, 4, 6, 10, 12, and trial completion (median = 14 months, range = 6 to 22 months). It is a single-blind trial, with research personnel blinded. All patients have free access to their respective digital intervention, ODYSEE-vCHAT or enhanced usual care (eUC). Subjects are invited by weekly emails to participate in the resources available to their group. eUC patients have access to educational materials for CHF self-care that are available to the public on professional websites. Participation in supplementary programs that provide CHF self-care education is not restricted. However, supplementary program activity will be statistically controlled for in the outcome assessments. Participation in supplementary health programs is monitored by self-reported status in the assessments.

ANALYSES

Separate generalized linear models (GLMs) will evaluate ODYSSEE-vCHAT versus eUC for primary and secondary outcomes. GLMs will be adjusted for baseline assessments and potential covariates. Interactions between treatment arm and gender will be examined for each outcome, using Bonferroni post-hoc comparisons for relevant subgroups. Significance in all tests will be p<0.05, 2-sided.

Description

INTRODUCTION

Chronic heart failure (CHF) is a progressive clinical syndrome in which the heart is unable to pump oxygenated blood sufficiently to meet metabolic demands during exercise or at rest. At age 55, the lifetime risk for CHF is 29% for women and 33% for men. CHF is a major cause of psychological distress and reduced quality of life. The one-year rehospitalization rate is 40%. The five-year mortality rate is 45% for women and 60% for men. International task force committees report that medical therapy combined with patient education for CHF self-care optimizes clinical outcomes.

Cardiovascular mortality incidence decreases with incremental adherence to self-care. Improvement in CHF self-care also predicts greater quality of life at 12 months. However, patient adherence to self-care is problematic. In the absence of intervention, only 9-36% of CHF patients have moderate to high adherence to these behaviours. Key patient barriers to self-care are low health literacy and social isolation, which are present for 39% and 25% of CHF patients, respectively. These barriers are associated with depressed mood and low motivation, which further increases risk for non-adherence and poor clinical outcomes.

Home-based telehealth programs such as the current ODYSSEE-vCHAT digital initiative are currently changing practice standards for outpatient medical care. A telehealth program of social network support that is integrated with automated digital counselling is central to this proposal. This approach has demonstrated potential to improve overall wellbeing while increasing engagement with digital programs and sustaining preventive self-care with positive role modelling, information sharing, and structured presentations.

RATIONALE

Task force statements advocate digital interventions that are patient-centred, scalable, and can improve clinical outcomes while reducing healthcare costs. Telehealth trials have increased therapeutic outcomes with reduced heterogeneity when an evidence-based protocol of behavioural counselling is used. Furthermore, the development of home-based telehealth programs such as the ODYSSEE-vCHAT digital initiative is consistent with task force guidelines for COVID-19 prevention. Integrating a social network intervention with an automated (scalable), evidence-based digital program for CHF self-care is likely to optimize therapeutic benefits. A digital social network initiative is central to this proposed pilot trial because of its potential to (i) sustain patient engagement with CHF self-care resources, (ii) promote self-care learning and positive role modelling through information sharing or structured presentations, and (iii) improve quality of life and health literacy while reducing perceived social isolation. Peer support is associated with increased self-care adherence. These findings highlight the importance of determining whether a social network program enhances the therapeutic benefit of (individual-focused) telehealth services.

HYPOTHESES

The primary hypothesis is that, at trial completion (median = 14 months, range = 6 to 22 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) will significantly reduce the risk for a composite index of incident all-cause mortality, all-cause emergency department (ED) visits, or CHF-related hospitalization (based on linkage to health administrative a data base).

The secondary hypothesis is that participant engagement with CHF self-care resources [defined by (i) sum login minutes, (ii) sum logins, and (iii) number of login days prior to a login lapse 2 months] at months 2, 4, 6, 10, and 12 and trial completion (range = 6 to 22 months) will be greater in ODYSSEE-vCHAT versus eUC, and independently associated with the following outcomes: Increased health-related quality of life, adherence to CHF self-care behaviours, quality of life activities, overall mental health, practice of COVID-19 protective behaviours, health literacy, active involvement in medical care, and perceived social support, as well as decreased depression, anxiety, loneliness, and use of alcohol, cigarettes, and cannabis.

POTENTIAL RISKS

Participants may feel uncomfortable using ODYSSEE-vCHAT because they are not familiar with the software or a computer, answering certain questions posed in the questionnaire packages, contributing to the weekly discussions on Zoom due to privacy concerns, or submitting an audio or video comment on the weekly presentations and discussions because they would no longer be an anonymous participant in the trial. Audio or video comments may also be used for research and educational purposes in the public domain.

SAFETY PARAMETERS

The research team will provide assistance in using ODYSSEE-vCHAT through video tutorials and over the telephone, if required.

The research team will accommodate a refusal to respond to any question(s) posed in the questionnaire packages.

During webcasts, visual input from patients remains disabled to protect their identification. If participants would like to contribute to the discussion without speaking, they may opt to use the chat feature on Zoom instead. Comments written in the chat are not included in the recording of the session.

Participants' audio or video comments are censored for inappropriate comments pertaining to violence, sexual content, coarse language, etc. If a patient's video is selected for presentation to other participants in the trial, or to the public, the patient will be notified so that they have an opportunity to grant or withhold their permission for this use of their video.

The social network chatrooms are HIPPA compliant and moderated by three levels of content filtering to ensure that posts meet conventional standards of ethical conduct. Level 1 is a search algorithm that is automatically updated with banned word lists. Level 2 is self-report by patient volunteers as in prior research. Level 3 is done manually by research assistants.

STATISTICAL PLAN

  • Primary outcome: At trial completion, a time-to-event analysis will be conducted using a multivariable Cox Proportional Hazards model to evaluate if ODYSSEE-vCHAT versus eUC reduced risk for the composite endpoint. Potential confounders will be selected using forward (P < 0.05) and backward (P < 0.10) stepwise selection.
  • Secondary outcomes: General linear models (GLMs) will evaluate if ODYSSEE-vCHAT versus eUC evokes greater program adherence at months 2, 4, 6, 10, and 12 and trial completion, adjusting for potential baseline confounders. The GLM will be repeated using sum logins as the dependent variable. A multivariable Poisson model will evaluate whether ODYSSEE-vCHAT versus eUC is associated with greater duration of engagement, adjusting for potential confounding variables. Separate GLMs will evaluate if ODYSSEE-vCHAT versus eUC improves self-reported outcomes at months 2, 4, 6, 10, and 12 and trial completion, adjusting for baseline assessment for each endpoint and potential baseline covariates. Clinical interpretation for health-related quality of life will be based on a group difference 5 points. Bonferroni post-hoc tests will be used to assess interactions for relevant groups. Significance in all tests is p < 0.05, 2-sided.
  • Exploratory analyses: Separate analyses will be conducted for gender. The Cox Proportional Hazards Model or competing risk models will be used for CHF-specific endpoints of mortality, hospitalization, and ED visits, separately and collectively.

DEVIATIONS FROM STATISTICAL PLAN

Since the statistical plan involves exploratory analyses, a need to deviate from it is not expected. Nevertheless, the statistical analysis and methodology committee will be consulted regularly throughout the trial. Any unplanned analyses will be adjusted using the Bonferroni procedure.

SAMPLE SIZE

Researchers recently reported a reduction over 12 months in a composite index score of all-cause mortality and hospitalization for telehealth support (50.6%) versus usual care (59.3%), p = 0.01. This yielded a sample estimate of 142. Using a 14.7% adjustment rate (142*1.147) for withdrawal or attrition based on values obtained from CHF-CePPORT (6.5% of patients withdrew and 8.2% were lost to follow-up), the final sample size estimate is 162, with a type 1 error of 5% and a power of 80%.

SUBJECT COMPLIANCE

Attendance for assessments will be facilitated by telephone and email reminders if participants fail to complete these within 7 days after receiving the hyperlinks to the online questionnaire packages.

SUBJECT WITHDRAWAL

Adverse events such as an unforeseen mental health crisis may affect a patient's ability to participate in this trial. In cases of patient withdrawal, all data up to this point pertaining to the patient will be used for outcome analyses. The Steering Committee will review how and whether the subject should be replaced in the trial. The referring cardiologist will be alerted about the withdrawal.

CRITERIA FOR TRIAL TERMINATION

The ODYSSEE-vCHAT trial will be terminated prematurely in the event of a recurrent adverse event that is related to our trial procedures or content.

QUALITY CONTROL AND ASSURANCE

The Data Review/Monitoring Committee will ensure that the trial meets an appropriate standard for data quality control. The Steering Committee will adjudicate primary and secondary outcomes and review and advise the team about the progress of ODYSSEE-vCHAT, protocol compliance, and any adverse incidents.

CONSENT

Cardiologists and their nursing staff in participating outpatient clinics will identify patients who meet trial criteria and will obtain verbal consent to be approached by the research team. The research coordinator or a research assistant will either approach the potential participant in the clinic or enter electronic patient records to obtain their contact information. Informed consent may be obtained in person or virtually.

This trial will also be advertised to CHF patients on patient education websites, on posters in participating outpatient clinics, and through mass emailing. Patients who contact the research team through advertising will be sent our Referral Form via email, to be completed and submitted to us via email by their physician. The Referral Form will screen potential participants based on our inclusion and exclusion criteria. Potential participants who qualify for the trial will then be directed through the consenting process virtually.

Participants will be recruited continuously until our target sample size is obtained.

DATA STORAGE

All data is stored on secure servers within the UHN digital environment for at least 10 years after trial completion.

PRIVACY AND CONFIDENTIALITY

Subjects are issued a tracking number when information regarding any identifying information is transmitted for analysis. Subject anonymity and confidentiality will be preserved. Only aggregate data will be published.

All research personnel have signed an employee confidentiality agreement ensuring that confidential information is not disclosed to any other person or entity. All source documents containing personal identifiers are stored in filing cabinets under lock and key. The database is stored electronically on the firewall-protected server, making it inaccessible externally. Access to the room, which contains the research file server, is restricted to designated persons who are employed by the Behavioural Cardiology Research Unit at the UHN.

Discussion of the trial with persons outside the research team will never reveal personal identifiers of participants. All access to data will be denied to persons outside the research team. Data transmission will occur via encrypted storage material over the Internet.

Details
Condition Chronic Heart Failure
Treatment ODYSSEE-vCHAT
Clinical Study IdentifierNCT04966104
SponsorUniversity Health Network, Toronto
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Biological males and females who are 18 years of age or older and who are diagnosed with heart failure with reduced ejection fraction (systolic heart failure) corresponding to the New York Heart Association Classes 2 to 4 (NYHA II-IV) for 3 or more months prior to enrollment
Left ventricular ejection fraction (LVEF) less than or equal to 40% with documentation by ventriculography or quantitative echocardiography (these data are readily available as per standard of care)
No worsening of chronic heart failure for 1 month prior to recruitment, as determined by a referring physician
Medical treatment determined by the referring physician adheres to Canadian Cardiovascular Society guideline-directed therapy for at least 1 month prior to enrollment
Oral and written comprehension of English
Personal access to a computer
Informed written consent

Exclusion Criteria

Preserved ejection fraction [these patients often exhibit normal brain natriuretic peptide levels and a high rate of non-cardiac mortality (approximately 30%), which would confound our evaluation of ODYSSEE]
Scheduled for advanced surgical therapy (e.g., heart transplantation or implantation of a left ventricular assistive device) within 3 months of enrollment
Previous heart transplant
Record of significant comorbidities at enrollment [e.g., renal failure (serum-creatinine greater than or equal to 300 micromoles/L or 3.0 mg/dL), liver disease (alanine transaminase greater than the three-fold upper limit of normal), poorly controlled diabetes (fasting blood glucose greater than 10 mmol/L or hemoglobin A1C greater than 8%)
Hypotension and/or systolic blood pressure less than or equal to 85 mmHg
Persistent systolic or diastolic hypertension (systolic greater than 170 mmHg or diastolic greater than 100 mmHg despite antihypertensive therapy)
Chronic heart failure secondary to primary uncorrected valvular cardiomyopathy, predominant right-sided heart failure, or a non-cardiac disease (e.g., complex congenital heart disease)
Severe psychiatric disorder that requires acute psychiatric care, as determined by a referring physician (e.g., psychosis or bipolar mood disorder)
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