Clinical trial NCT04966104: ODYSSEE-vCHAT Pilot Trial for Heart Failure
Official title: ODYSSEE-vCHAT Pilot Trial: a Virtual Community Promoting Health Literacy, Self-Care, and Peer Support for Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Digital health
Digital counselling
Self-care
Clinical trial
Clinical outcomes
Cognitive-behavioural therapy
Health-related quality of life
Motivational interviewing
eHealth
Social Networking
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Mount Sinai Hospital, Canada
First posted: 2021-07-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double arm, parallel group, single-blind randomized trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: INTRODUCTION

Psychological distress and reduced quality of life are prevalent within the heart failure (HF) population. The 1-year rehospitalization (40%) and 5-year mortality (45% for women and 60% for men) rates are high. International task force committees report that medical therapy combined with counselling for HF self-care optimizes clinical outcomes.

HYPOTHESES

At trial completion (median = 8.5 months, range = 2 to 15 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) is predicted to reduce morbidity and mortality rates. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 4, 8, and 12 and trial completion.

RECRUITMENT

HF patients who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and the community. Accrual of the sample (N = 61) occurred over 13 months.

DESIGN

ODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months). It is a single-blind trial, with research personnel blinded (excluding the research coordinator). All patients were provided with free access to their respective digital intervention, ODYSSEE-vCHAT or eUC. Subjects were invited by weekly emails to participate in the resources available to their group. eUC patients were provided with access to educational materials for HF self-care that are available to the public on professional heart health websites. Participation in supplementary programs that provide HF self-care education was not restricted, rather it was monitored by self-report during assessments and will be statistically controlled for during outcome assessments.

ANALYSIS

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.

Detailed description: BACKGROUND

HF is a progressive clinical syndrome in which the heart is unable to pump oxygenated blood to meet the body's metabolic demands during exercise or at rest. At 55 years, the lifetime risk for HF is 29% for women and 33% for men. HF is a major cause of psychological distress and reduced quality of life. The 1-year rehospitalization rate is 40%. The 5-year mortality rate is 45% and 60% for women and men, respectively.

The incidence of cardiovascular mortality decreases with incremental adherence to self-care. Improvement in HF self-care also predicts greater quality of life at 12 months. However, in the absence of intervention, only 9-36% of HF patients have moderate to high adherence to these behaviours. Barriers to self-care include poor health literacy and social isolation, which are present in 39% and 25% of HF patients, respectively. These barriers are associated with depressed mood and low motivation, both of which increase the risk for poor clinical outcomes.

Home-based telehealth programs such as the present ODYSSEE-vCHAT digital initiative are 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 and sustain positive behavioural changes through information sharing, structured presentations, and role modelling.

RATIONALE

Task force statements advocate for digital interventions that are patient-centred, scalable, and can improve clinical outcomes while reducing healthcare costs. Furthermore, the development of home-based telehealth programs such as ODYSSEE-vCHAT is consistent with guidelines for COVID-19 prevention. Furthermore, integrating a social network intervention with an automated (scalable), evidence-based digital program for HF self-care is likely to optimize therapeutic benefits. A digital social network initiative is central to this trial because of its potential to (i) sustain patient engagement with HF self-care resources, (ii) promote self-care learning and positive role modelling through information sharing and structured presentations, and (iii) improve quality of life and health literacy while reducing perceived social isolation.

HYPOTHESES

The primary hypothesis is that ODYSSEE-vCHAT versus eUC will reduce the risk for a composite index of incident all-cause mortality, all-cause emergency department (ED) visits, and HF-related hospitalization (based on linkage to health administrative a data base) at trial completion (median = 8.5 months, range = 2 to 15 months).

The secondary hypothesis is that engagement with HF self-care resources \[defined by (i) sum logon minutes, (ii) sum logons, and (iii) number of logon days prior to a logon lapse ≥ 2 months\] at months 4, 8, and 12 and trial completion (range = 2 to 15 months) will be independently associated with the following outcomes:

* Health-related quality of life
* Adherence to HF self-care
* Engagement in activities for living well
* Overall mental health
* Health literacy
* Active involvement in medical care
* Perceived social support
* Depression
* Anxiety
* Loneliness
* Use of alcohol, cigarettes, and cannabis

POTENTIAL RISKS

Participants may have experienced discomfort with the following:

* Responding to items in the assessments that are considered personal
* Using ODYSSEE-vCHAT because they are not familiar with the software
* Verbally contributing to the discussion segments of the webcasts as their voice would be recorded
* Submitting an audio or video response to the webcasts because they would no longer be an anonymous participant (audio or video comments may also be used for research and educational purposes in the public domain)

SAFETY PARAMETERS

Refusals to respond to any item(s) posed in the questionnaire packages were accommodated.

Video tutorials on how to use ODYSSEE-vCHAT were provided. Assistance over the telephone was offered when required.

During webcasts, visual input from patients remained disabled to protect their identification. If participants preferred to contribute to the discussion without speaking, they were encouraged to use the chat feature on Zoom instead. Comments written in the chat were not included in the recording of the session.

Participants' audio or video comments were censored for inappropriate comments pertaining to violence, sexual content, coarse language, etc. In regards to videos that were selected for presentation to other participants in the trial, or to the public, patients were notified so that they have an opportunity to grant or withhold their permission for this use of their video.

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 was a search algorithm that is automatically updated with banned word lists. Level 2 was carried by patient volunteers through self-report. Level 3 is performed by research assistants.

Finally, subjects in the intervention arm were offered an opportunity to send the unblinded research coordinator photographs via email which depict heart-healthy lifestyles. Patients were asked not to include any identifying, sensitive, or personal information (e.g., faces, family members, personal health information, etc.) in the photographs, which would be shared with other participants to encourage social interaction. Participants were informed that they could contact the research team at any time to have their photo submissions withdrawn.

STATISTICAL PLAN

Primary outcome:

At trial completion (median = 8.5 months, range = 2 to 15 months), a time-to-event analysis will be conducted using a multivariable Cox Proportional Hazards model to evaluate if ODYSSEE-vCHAT versus eUC reduced the composite endpoint. Potential confounders will be selected using forward (p \< 0.05) and backward (p \< 0.10) stepwise selection.

Secondary outcomes:

GLMs will evaluate if ODYSSEE-vCHAT versus eUC evokes greater program adherence at months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months), adjusting for potential baseline confounders. The GLM will be repeated using sum logons 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 4, 8, and 12 and trial completion, adjusting for endpoints at baseline and potential baseline covariates. Clinical interpretation for health-related quality of life will be based on a group difference of greater than or equal to 5 points. Bonferroni post-hoc tests will be used to assess interactions for relevant groups. Significance in all tests will be p \< 0.05, 2-sided.

Exploratory outcomes:

Separate analyses will be conducted for gender. The Cox Proportional Hazards Model or competing risk models will be used for HF-specific endpoints of mortality, hospitalization, and ED visits, separately and collectively.

DEVIATIONS FROM STATISTICAL PLAN

A need to deviate from the statistical plan was not expected as it involves exploratory analyses. Nevertheless, the Statistical Analysis and Methodology Committee was 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 was 162, with a type 1 error of 5% and a power of 80%. However, the accrued sample size was N = 61.

COMPLIANCE

Attendance for assessments was facilitated by telephone and email reminders if a participant fails to complete an assessment within 5 to 7 days of receiving the initial invitation.

WITHDRAWAL

Adverse events such as an unforeseen mental health crisis may have affected 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 were responsible for reviewing how and whether the subject should be replaced in the trial. The referring cardiologist would have been alerted about the withdrawal.

CRITERIA FOR TRIAL TERMINATION

The ODYSSEE-vCHAT trial would have been terminated prematurely in the event of a recurrent adverse event that was related to our trial procedures or content.

QUALITY CONTROL AND ASSURANCE

The Data Review or Monitoring Committee ensured that the trial met an appropriate standard for data quality control. The Steering Committee adjudicated primary and secondary outcomes, as well as reviewed and advised the team about the trial's progress, protocol compliance, and any adverse incidents.

CONSENT

Cardiologists and their nursing staff in participating outpatient clinics identified patients who met trial criteria and obtained verbal consent to be approached by the research team. Research personnel either approached the potential participant in the clinic or entered electronic patient records to obtain their contact information. Informed consent was obtained in person or virtually.

This trial was advertised to HF patients on patient education websites, on posters in participating outpatient clinics, and through mass emails. Patients who contacted the research team through advertising were sent our Referral Form via email to be completed and returned via email by their physician. The Referral Form screened potential participants based on the inclusion and exclusion criteria. Potential participants who qualified for the trial were then directed through the consenting process virtually.

DATA STORAGE

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

Data will be available from the corresponding author pending approval of research ethics boards of participating institutions and on reasonable request received from qualified researchers trained in human subject confidentiality protocols.

PRIVACY AND CONFIDENTIALITY

Subjects are issued a tracking number when data involving identifying information is transmitted for analysis. Subject anonymity and confidentiality has been 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 containing 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 is denied to persons outside the research team. Data transmission occurs via encrypted storage material over the Internet.

Eligibility criteria: Inclusion criteria:

* Biological males and females who are at least 18 years old and diagnosed with HF with reduced, mid-range, or preserved ejection fraction corresponding to the New York Heart Association Classes 2 to 4 (NYHA II-IV) for 3 or more months prior to enrollment
* Reduced (less than or equal to 40%), mid-range (41 to 49%), or preserved (equal to or greater than 50%) left ventricular ejection fraction, with documentation by ventriculography or quantitative echocardiography (these data are readily available as per the standard of care)
* No worsening of HF for 1 month prior to recruitment, as determined by a referring physician
* Receiving medical treatment in compliance with the Canadian Cardiovascular Society's guideline-directed therapy for at least 1 month prior to enrollment
* Oral and written comprehension of English
* Personal access to an email address, a computer, and the Internet
* Informed written consent

Exclusion criteria:

* Scheduled for advanced surgical therapy (e.g., heart transplantation or implantation of a left ventricular assistive device) within 3 months of enrollment
* Record of significant comorbidities at enrollment that is expected to prohibit full participation (e.g., dementia, psychosis, or severe depression)
* HF secondary to uncorrected valvular cardiomyopathy, predominant right-sided HF, or a non-cardiac disease

Primary outcomes:
measure: Composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization
timeFrame: Trial completion (median = 8.5 months, range = 2 to 15 months)
Secondary outcomes:
measure: Incidence of all-cause mortality
timeFrame: Trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Incidence of all-cause ED visits
timeFrame: Trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Incidence of HF-related hospitalization
timeFrame: Trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Engagement with HF self-care resources
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported health-related quality of life
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Adherence to heart failure self-care behaviours
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported engagement in activities for living well
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported overall mental health
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported depression
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported anxiety
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported loneliness
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported psychological wellbeing
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported involvement in medical care
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported health literacy
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported physical wellbeing
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported perceived social support
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
measure: Self-reported alcohol, nicotine, and cannabis use
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
Other outcomes:
measure: Gender interactions
timeFrame: Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Rob P Nolan, PhD
role: PRINCIPAL_INVESTIGATOR
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