Clinical trial NCT05560737: ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Official title: ODYSSEE-vCHAT Mental Health Study: A Virtual Community Promoting Health Literacy, Self-Care, and Peer Support for Heart Failure and Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Heart Failure
Chronic Kidney Diseases
Keywords: Digital counselling
Social network support
eHealth
Self-care
Mental health
COVID-19
Cognitive behavioural therapy
Motivational interviewing
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Mount Sinai Hospital, Canada
name: The Ottawa Hospital
First posted: 2022-09-29
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (18 years or older) biologically-born males and females diagnosed with CHF or CKD and fluent in English, with access to a computer, email address, and the Internet

Brief summary: INTRODUCTION

Psychological distress and reduced quality of life are prevalent in patients with chronic heart failure (CHF) and advanced chronic kidney disease (CKD). In addition, persons with CHF or CKD live with increased risk of primary or secondary complications associated with COVID-19, including mortality. International task force committees report that medical therapy combined with counselling for CHF and CKD self-care optimizes clinical outcomes. Digital health initiatives present an effective solution in light of the recent issue of declining patient attendance in essential outpatient appointments due to the increased risk of COVID-19 exposure.

HYPOTHESES

At study completion (up to 16 months), it is hypothesized that there will be a significant increase from baseline in the proportion of participants with clinically improved or sustained positive mental health. Additionally, greater engagement with the ODYSSEE-vCHAT program is expected to be linked with improved self-reported health- and wellbeing-related outcomes at months 4 and 8 and study completion (up to 16 months).

RECRUITMENT

Patients with CHF or CKD who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, The Ottawa Hospital, and the community. Accrual of the sample (N = 215) occurred over a 14-month period.

DESIGN

This is a single group, open label, pre-post study with assessments at baseline, months 4 and 8, and study completion (up to 16 months). ODYSSEE-vCHAT contacted subjects each week inviting them to participate or partake in digital counselling resources, chatrooms, and presentations with group discussions. Participation in supplemental mental health programs was monitored by self-report.

ANALYSES

A binomial logistic regression will evaluate if there is a greater proportion of participants with positive mental health at study completion. This analysis will assess if the proportion of participants with positive mental health at study completion (up to 16 months) is independently associated with ODYSSEE-vCHAT engagement (login minutes). General linear models will test secondary outcomes, adjusting for baseline assessments and potential covariates. Significance in all tests will be p \< 0.05, 2-sided. Any unplanned analyses will be adjusted for using the Bonferroni procedure.

Detailed description: BACKGROUND

Mental health needs are pronounced for individuals with CHF or advanced CKD. Clinically significant symptoms of depression and anxiety are prevalent in 22% and 33% of outpatients with CHF, respectively, and 26% and 12-52% of outpatients with CKD, respectively. Two psychosocial factors are known to compound the disease burden experienced by persons with these chronic progressive conditions: Diminished social support and isolation. These factors compromise patients' psychological wellbeing and quality of life, while contributing to caregiver burden or stress. Additionally, persons with CHF or CKD experience an increased risk of exposure to COVID-19 and associated mortality. The impact of the pandemic on mental health includes greater symptoms of anxiety, mood disturbance, social isolation due to social distancing, disruption to sleep or eating patterns, impaired concentration due to stress, and use of drugs or alcohol.

A digital program of social network support that is integrated with automated counselling is central to this proposal. This approach has demonstrated a potential to improve psychological wellbeing and quality of life while reducing social isolation, increase patient engagement with digital programs, and sustain preventive self-care for mental health with positive role modelling, information sharing, and structured presentations. Home-based digital health programs are changing practice standards for outpatient medical care. This development is consistent with task force guidelines for infection prevention and control that advocate for the development of virtual outpatient programs. Digital health initiatives are also well-suited to effectively address the recent problem that patients are declining to attend essential outpatient appointments due to fear of COVID-19 exposure.

The present study will generate novel insights on how to optimize the efficacy and usability of a scalable, evidence-based digital program where social network technology and automated counselling are used synergistically to promote mental health for persons at increased risk for COVID-19.

RATIONALE

Meta-analysis indicates a login rate of only 72% and a mean dropout rate of 15% (range = 0 to 62%) in digital health programs, which undermines population reach. The ODYSSEE-vCHAT proposal is consistent with COVID-19 task force recommendations to develop patient-centered, evidence-based digital interventions that can sustain patient engagement and scale to the wider population to optimize quality of life and mental health. A previous trial of automated digital counselling for CHF increased patient engagement over 12 months by 37% relative to a control group receiving enhanced usual care, and participation was independently associated with improved quality of life. ODYSSEE-vCHAT, with its added social network components, is designed to improve upon this outcome.

HYPOTHESES

The primary hypothesis is that, at completion (up to 16 months), there will be an increase from baseline in the proportion of participants with clinically improved or sustained positive mental health, defined as a "minimally important increase" of ≤ 3.8 points or a score of ≤ 65 on the Mental Component Summary (MCS) of the 36-Item Short-Form Survey.

The secondary hypothesis is that engagement with self-care resources \[defined by (i) sum login minutes, (ii) sum logins, and (iii) number of login days prior to a lapse of ≥ 1 month\] at months 4 and 8 and study completion\] will be independently associated with the following outcomes:

* Decreased depression, anxiety, loneliness, and use of alcohol, nicotine, and cannabis
* Increased psychological wellbeing, health-related quality of life, adherence to self-care behaviours (CHF only), engagement in goal-directed activities for living well, health literacy, active involvement in medical care, perceived social support, and physical functioning

Additionally, participant engagement with self-care resources will be independently and positively associated with the proportion of participants demonstrating improved or sustained positive mental health.

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. Regarding videos that were selected for presentation to other participants in the trial, or to the public, patients were notified so that they had an opportunity to grant or withhold their permission for this use of their video.

Social network chatrooms were 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 was performed by research assistants.

Finally, subjects were offered an opportunity to send the research team photographs via email which depict healthy lifestyles. Patients were asked not to include any identifying, sensitive, or personal information in the photographs, which would be shared with other participants to encourage social interaction. Participants were informed that they may contact the research team at any time to have their photo submissions withdrawn.

STATISTICAL PLAN

Primary outcome:

At study completion, the McNemer c2 test will assess if there is a greater proportion of participants with positive mental health at study completion. A binomial logistic regression will evaluate if the proportion of participants with positive mental health at study completion is independently associated with vCHAT engagement. Covariates will include CHF or CKD diagnosis, reported gender, registered COVID-19 diagnosis, age, income, and participation in a supplemental mental health program.

Secondary outcomes:

General linear models will assess if separate outcomes at months 4, 8, and study completion (up to 16 months) demonstrate a significant therapeutic change in:

* Depression
* Anxiety
* Perceived social support
* Loneliness
* Health-related quality of life
* Adherence to self-care (CHF only)
* Engagement in goal-directed activities for living well
* Health literacy
* Active involvement in medical care
* Use of alcohol, cigarettes, and cannabis

Generalized estimating equation models will assess if the proportion of participants with positive MCS status at study completion is independently associated with ODYSSEE-vCHAT engagement for each subcomponent of digital counselling and social network support across assessments. Covariates will include assessment intervals.

Exploratory outcomes:

Separate analyses will be conducted for gender. The association between engagement with self-care resources and overall mental health will also be analyzed.

DEVIATIONS FROM STATISTICAL PLAN

Since the statistical plan involves exploratory analyses, a need to deviate from was not anticipated. Nevertheless, the Statistical Analysis and Methodology Committee were consulted regularly. Any unplanned analyses will be adjusted using the Bonferroni procedure.

SAMPLE SIZE

A recent study reported a significant 12-month improvement on the MCS for telehealth support versus usual care. Within-group change on the MCS for telehealth was 3.81 (standard deviation = 10.7). The sample size required to replicate this outcome for ODYSSEE-vCHAT is 188. With a recruitment period of 8 months, a minimum follow-up of 3 months, and a 14.7% rate of withdrawal or attrition (based on the CHF-CePPORT trial), the final sample size estimate is 240, (α = 0.05, β = 0.80). However, a total sample size of N = 215 was accrued.

SUBJECT COMPLIANCE

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

SUBJECT 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 would review how and whether the subject should be replaced in the trial. The referring cardiologist or nephrologist would be alerted about the withdrawal.

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 or nephrologists 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 CHF and CKD 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 study completion.

PRIVACY AND CONFIDENTIALITY

Subjects are issued a tracking number when information regarding any identifying information is transmitted for analysis. Subject anonymity and confidentiality is 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 Cardiac eHealth laboratory at the UHN.

Discussion of the study 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 will occur via encrypted storage material over the Internet.

Eligibility criteria: Inclusion criteria:

* Biological males and females who are 18 years
* Diagnosed with CHF, including reduced (≤ 40%), mid-range (≥ 41 and ≤ 49%), or preserved (≥ 50%) ejection fraction based on New York Heart Association Classes 2 to 4 (NYHA II-IV) for 3 or more months prior to enrollment, OR diagnosed with advanced CKD (\> 10% risk of requiring dialysis within 2 years using the 4-variable, 2-year Kidney Failure Risk equation) or end-stage renal disease and on dialysis
* 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., transplantation) 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)
* Life expectancy \< 1 year

Primary outcomes:
measure: Self-reported overall mental health
timeFrame: Baseline and study completion (up to 16 months)
Secondary outcomes:
measure: Self-reported depression
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported anxiety
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported loneliness
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported psychological wellbeing
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported CHF health-related quality of life
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported CKD health-related quality of life
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported engagement in goal-directed activities for living well
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported adherence to self-care behaviours (CHF only)
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported active involvement in medical care
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported social support
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported physical functioning
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Self-reported alcohol, nicotine, and cannabis use
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
measure: Engagement with self-care resources
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
Other outcomes:
measure: Gender interactions
timeFrame: Baseline, months 4 and 8, and study completion (up to 16 months)
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
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: Robert P Nolan, PhD
role: PRINCIPAL_INVESTIGATOR
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