ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients

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.

Conditions

• Chronic Heart Failure
• Chronic Kidney Diseases

Interventions

BEHAVIORAL

ODYSSEE-vCHAT

ODYSSEE-vCHAT consists of: * Automated digital counselling resources (educational pages, videos, tools, and trackers) * Chatrooms available 24/7 * Weekly 30-minute presentations and discussions led by a healthcare professional or patient representative Each aspect was informed by a rotating schedule of 7 weekly self-care themes. Webcasts were recorded and streamed to our private YouTube channel, and associated hyperlinks were shared on the program. Subjects had the option of submitting photographs depicting heart-healthy lifestyles and activities (with no identifying, sensitive, or personal information) to the Gallery Wall. Subjects were invited by email to access the resources available to them. They logged on to the program using password-protected personal accounts. Each participant's total number of logins and login time (with timestamps) were recorded. Assessments occurred online at baseline, months 4 and 8, and study completion (up to 16 months).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Mount Sinai Hospital, Canada

  collaborator OTHER

• The Ottawa Hospital

  collaborator OTHER

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Robert P Nolan, PhD · University Health Network, Toronto

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-14

Primary Completion

2023-01-16

Completion

2023-12-31

Countries

• Canada

Study Locations