NCT07217366

Brief Summary

The goal of this study is to see whether this type of Artificial Intelligence (AI) Voice Assistant can reliably capture patient-reported health information to support communication between patients and their healthcare team.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

October 13, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

October 13, 2025

Last Update Submit

March 23, 2026

Conditions

Keywords

Artificial intelligenceSpeech-to-textPatient-reported dataDigital healthPatient self-care

Outcome Measures

Primary Outcomes (1)

  • Accuracy of AI Voice Assistant Compared With Expert Extraction

    Agreement between AI-generated summaries and expert-reviewed responses (study staff extraction of participants' responses from audio recordings). The responses will be scored on a numerical scale, ranging from 0-17 points with higher points representing greater accuracy of the AI-generated summaries compared to expert-reviewed responses.

    ~3 months

Secondary Outcomes (4)

  • Usability of AI Voice Assistant

    ~3 months

  • Agreement between AI Voice Assistant Compared With Patient Self-Reported Written Responses

    ~3 months

  • Kansas City Cardiomyopathy Questionnaire Scores

    ~3 months

  • Qualitative Feedback

    ~3 months

Other Outcomes (1)

  • Time

    ~3 months

Study Arms (1)

AI Voice Assistant

EXPERIMENTAL

Participants in the AI Voice Assistant arm will complete two activities: (1) an interaction with the AI Voice Assistant tool and (2) Paper survey that includes the same questions asked by AI voice assistant. Half of the participants will use the AI Voice Assistant first, while the other half will begin with the paper survey.

Other: Artificial intelligence speech-to-text tool

Interventions

Pilot testing of speech-to-text tool using artificial intelligence

AI Voice Assistant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with heart failure receiving cardiology care at Stanford University

You may not qualify if:

  • Diminished decision-making capacity
  • Inability to understand and communicate in English sufficiently to complete study procedures
  • Inability to complete study procedures to the best of the participant's and investigator's knowledge
  • Any disorder or condition that, in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures or completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Alexander Sandhu, MD, MS

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine (Cardiovascular Medicine)

Study Record Dates

First Submitted

October 13, 2025

First Posted

October 16, 2025

Study Start

October 13, 2025

Primary Completion

May 1, 2026

Study Completion

June 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Investigators can provide documents including the study protocol, study analysis plan, and informed consent form of the study to researchers who request the information

Shared Documents
STUDY PROTOCOL
Time Frame
December 2025-December 2026

Locations