Trial Protocol & Operations

Objective: For PI, IRB, and Clinical Research Operations teams.

TL;DR: Trial Ops Kit

• Protocol: Customizable template for HF/Post-MI study.
• Design: Bayesian SMART (Sequential Multiple Assignment Randomized Trial).
• Status: Protocol shell ready; parameterization requires TA3 input.

1. HF/Post-MI Protocol Overview

• Population: Patients discharged with primary dx of Heart Failure or AMI.
• Intervention: AI-guided care navigation + remote monitoring vs. Usual Care.
• Endpoints:
  • Primary: Re-hospitalization rate (30-day / 90-day).
  • Secondary: GDMT adherence, KCCQ scores, patient engagement.

2. Data Capture Plan

The Regain platform automatically captures:

• Patient Reported Outcomes (PROs): Via mobile app.
• Digital Biomarkers: Activity, sleep, vital signs.
• Engagement Metrics: Response times, adherence rates.
• Safety Signals: "Red flag" triggers and escalation events.

3. IRB Starter Kit

We provide a packet to accelerate your IRB submission:

• Consent Scaffolding: Modular consent language for AI interactions.
• Risk Assessment: Detailed "Algorithm Safety" dossier.
• Data Flow Diagram: For privacy review.

4. TA3 Adaptation

• What YOU define: Inclusion/Exclusion specific to your site, local care pathways.
• What WE provide: The "Trial Operations Kit" software and statistical analysis plan structure.

Last Updated: 2026-01-20