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

NCT05560737 | Unknown

• 5 other identifiers: 20-6005MS2173076378721-0057-E20220139-01H
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• Self-reported overall mental health

  The primary goal of the study is to evaluate whether engagement with ODYSSEE-vCHAT significantly changes from baseline the proportion of participants with clinically improved or sustained positive mental health (defined as a "minimally important increase" of at least 3.8 points or a score of at least 65 on the MCS) at study completion.

  Baseline and study completion (up to 16 months)

Secondary Outcomes (13)

• Self-reported depression

  Baseline, months 4 and 8, and study completion (up to 16 months)

• Self-reported anxiety

  Baseline, months 4 and 8, and study completion (up to 16 months)

• Self-reported loneliness

  Baseline, months 4 and 8, and study completion (up to 16 months)

• Self-reported psychological wellbeing

  Baseline, months 4 and 8, and study completion (up to 16 months)

• Self-reported CHF health-related quality of life

  Baseline, months 4 and 8, and study completion (up to 16 months)

Other Outcomes (1)

• Gender interactions

  Baseline, months 4 and 8, and study completion (up to 16 months)

Interventions

ODYSSEE-vCHAT BEHAVIORAL

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• Mount Sinai Hospital, Canada: collaborator
• The Ottawa Hospital: collaborator

Study Sites (4)

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

University Health Network

Toronto, Ontario, M2N 7A2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

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Related Links

• COVID-19 fears may be responsible for a 'dramatic drop' in cardiac patients seeking care.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Psychological Well-Being; COVID-19

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert P Nolan, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 29, 2022
• Study Start: September 14, 2021
• Primary Completion: January 16, 2023
• Study Completion: December 31, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)