Efficacy of Automated Digital Counseling for Chronic Heart Failure (ODYSSEE-vCHAT-CHF): A Randomized Controlled Pilot Trial (Preprint)
Authors: Montbriand Janice , Ross Heather , Chan Chris , Rac Valeria E , Huszti Ella , Arcand Joanne , Code Jilliane , Tomlinson George , Duero Posada Juan , Gentlin Andrew , Poon Stephanie , Mak Susanna , Kaczorowski Janusz , Grover Steven , Farkouh Michael E. , Ghazi Wajiha , Nolan P Robert 
Published: December 2024

BACKGROUND

Chronic Heart Failure (CHF) is an increasing health burden associated with psychological distress, decreased quality of life, and high one year hospitalization rates (40%). CHF patients benefit from appropriate self-care and there is an increasing need for automated scalable programs to motivate and educate these patients.

OBJECTIVE

A Virtual Community Promoting Health Literacy, Self-care and Peer Support for Heart Failure (vCHAT-CHF Trial) used an automated scalable digital program: prOmoting health with DigitallY based counSeling of Self-care bEhavior and quality of life (ODYSSEE) to improve adherence and self-care in CHF patients, thereby improving health and health-related quality of life vs. enhanced usual care (eUC). The primary outcome was a composite index of all-cause hospitalization and emergency room (ER) visits. Secondary outcomes included changes in self-reported physical and psychosocial well-being.

METHODS

The vCHAT-CHF Trial was a 2-armed single-blind randomized control pilot trial. This was an evidence-based online multimedia digital health platform, based on cognitive behavioral and motivational interviewing techniques. ODYSSEE-vCHAT employed weekly topics on an interactive digital health platform, as well as weekly webcast presentations on various self-care themes and moderated online chat rooms, in addition to usual care.

RESULTS

61 CHF patients recruited from three tertiary hospitals in Canada were enrolled in the program for a median of 7 months. 44 (72%) of participants completed the endpoint assessment questionnaires (n= 19 (63%) in ODYSSEE-vChat vs. 25 (81%) in enhanced Usual Care (eUC)). Primary and secondary outcomes were investigated through linear and/or logistic multivariate models as appropriate, comparing program groups (e.g. ODYSSEE-vCHAT vs. eUC) by both intention-to-treat and treatment-received methods.

ODYSSEE-vCHAT was not associated with a composite of unplanned hospitalizations and/or ER visits in the current trial (23% usual care vs. 23% ODYSSEE, P = .78). However, multivariate logistic regression demonstrated that individuals in ODYSSEE-vCHAT (vs. eUC) were more likely (P = .003, OR = 6.0) to show clinically relevant change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) as defined by a change score ≥ 5 from baseline to end of trial. Multivariate linear regression showed that ODYSSEE-vCHATwas also associated with positive change in Self-Efficacy for Managing Chronic Disease (SEMCD6; P = .03, B = 4.38).

CONCLUSIONS

In summary, the vCHAT-CHF pilot trial showed that ODYSSEE-vCHATwas associated with clinically relevant change on the KCCQ and an increase in self-efficacy in management of chronic disease vs eUC, but failed to show a difference in number of hospitalizations and unplanned ER visits. This trial illustrated the potential of evidence-based automated digital health programs in self-management of CHF. Future research with a larger sample size may illuminate further relationships.

CLINICALTRIAL

ClinicalTrials.gov NCT04966104.