Automated digital counselling with social network support for chronic heart failure fails to improve health status but promotes health-related quality of life: ODYSSEE-vCHAT pilot trial
Authors: Nolan R P , Ross H J , Rac V , Huszti E , Arcand J , Code J , Thomas S , Tomlinson G , Duero Posada J , Gentlin A , Poon S , Kobulnik J , Mak S , Farkouh M 
Published: October 2024

Abstract

Background
Automated digital counselling programs have the potential to provide a scalable, complementary behavioural intervention to improve clinical outcomes for chronic heart failure (CHF).

Purpose
The primary hypothesis for this pilot trial was that automated digital counseling with social network support (ODYSSEE-vCHAT) vs. Usual Care would decrease the incidence of all-cause re-hospitalization or ED visits. Secondary outcomes included: minimal clinically important difference for improvement on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS), and improvement on ENRICHD Social Support Index (ESSI), Patient Health Questionnaire for Depression (PHQ-9) Godin-Shephard Leisure Time Physical Activity Scale (GSLTPAQ), and Self-Efficacy in Managing Chronic Disease (SEMCD6).

Methods
This 2-arm, parallel group, single-blind pilot trial randomized patients to ODYSSEE-vCHAT vs. Usual Care. Patients were ≥18 years of age with CHF (reduced ejection fraction [HFrEF] &lt; 40%, mid-range [HFmrEF] 40-49%, or preserved [HFpEF] ≥ 50%). Exclusion was based on inability to participate due to co-morbidities. All-cause hospitalization or ED visit were assessed digitally by hospital administrative data. Questionnaires were administered at baseline and end-of-study (approximately 8 months). The digital counselling protocol aimed to improve CHF self-care, HRQL, and adherence to medications, exercise, diet, and smoke-free living (Figure 1). The primary outcome was assessed using multivariable binary logistic regression. Secondary outcomes were assessed using multivariable linear regression analyses with ethno-racial group as a covariate.

Results
61 patients were randomized: ODYSSEE-vCHAT, n = 30 (49%), vs. Usual Care, n = 31 (51%). There were 2 deaths, 3 withdrawals, and 12 patients failed to complete secondary outcome assessments. Sample characteristics included mean age = 59 years (95% Confidence Interval, CI, 30, 76), gender identity as women, n = 23 (38%), ethno-racial group other than White, n = 17, (28%) and CHF with HFrEF, n = 47 (77%), HFmrEF, n = 8 (13%), and HFpEF, n = 4 (7%). Duration of enrollment to trial endpoint: mean = 247 days, (95% CI, 75, 382). Figure 2 indicates that ODYSSEE-vCHAT was not associated with lower incidence of all-cause hospitalization/ED visit: composite index events for Usual Care, n = 8 (28%), ODYSSEE-vCHAT, n = 7 (23%). However, ODYSSEE-vCHAT was associated with greater prevalence of KCCQ-OS change (≥ 5 points), and greater improvement in self-efficacy (SEMCD6) for managing CHF. There was a statistical trend to decreased prevalence of depression. Social support was inversely associated with ODYSSEE-vCHAT. No benefit was observed for physical activity (Figure 2).

Conclusions
Automated digital counselling with social network support promotes improvement in HRQL indices, but not health status. Findings for this pilot trial support a follow-up phase 2 randomized controlled trial.Digital Counselling ProtocolODYSSEE-vCHAT Outcomes