NCT06618092

Brief Summary

Background: Relisten is an artificial intelligence-based software developed by Recog Analytics that improves patient care by facilitating more natural interactions between healthcare professionals and patients. Relisten extracts relevant information from recorded conversations, structuring it in the medical record and sending it to the Health Information System after the professional\'s approval. This approach allows professionals to focus on the patient without the need to perform clinical documentation tasks. Method: This Proof of Concept (PoC) study is conducted as a multi-centre trial with the participation of several health professionals in Primary Care Centres (CAPs) of Amposta, Centelles, Artés, Sallent, Súria and the Consorci d\'Atenció Primària de Salut Barcelona Esquerra (CAPSBE). During the study, Relisten will be used in consultations under informed consent, followed by patient and professional surveys. Statistical analyses will be performed for each objective, using independent sample comparison tests according to normality evaluated with the Kolmogorov-Smirnov test and Lilliefors correction. The sample has been determined a priori to optimise the achievement of satisfactory results. Stratified statistical tests will also be performed to consider the variance between professionals. Discussion: The investigators expect an improvement in the quality of care perceived by patients and a significant reduction in the time spent taking clinical notes, with a saving of at least 30 seconds per visit. Although a high quality of the notes generated is expected, it is uncertain whether a significant improvement over the control group, which is already expected to have high quality notes, will be demonstrated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

February 21, 2025

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 12, 2024

Last Update Submit

February 20, 2025

Conditions

Keywords

Clinical notesambient technologyartificial intelligencedigital healthvoice recognitionprimary care

Outcome Measures

Primary Outcomes (2)

  • Relisten used

    Whether Relisten has been used in the consultation (YES/NOT)

    Day 1

  • Time saved

    Time saved in consultation in minutes

    Day 1

Secondary Outcomes (1)

  • Satisfaction surveys

    Day 1

Study Arms (2)

Intervention

EXPERIMENTAL

Relisten

Device: Relisten

Control

NO INTERVENTION

Usual care

Interventions

RelistenDEVICE

Patients will be attended using Relisten

Intervention

Eligibility Criteria

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

You may qualify if:

  • To have signed the informed consent form.
  • To carry out face-to-face medical and nursing consultations in Catalan and/or Castilian Spanish.
  • To be over 18 years old.

You may not qualify if:

  • Inability to understand the nature of the study.
  • Not fluent in Catalan or Castilian Spanish.
  • Not giving consent to be recorded.
  • Existence of any technical failure in the recording (e.g., internet service downtime).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CAP Amposta

Amposta, Catalonia, Spain

Location

CAP Artès

Artès, Catalonia, Spain

Location

CAP les Corts

Barcelona, Catalonia, Spain

Location

CAP Centelles

Centelles, Catalonia, Spain

Location

CAP Sallent

Sallent, Catalonia, Spain

Location

CAP Súria

Súria, Catalonia, Spain

Location

Related Publications (1)

  • Vidal-Alaball J, Alonso C, Heinisch DH, Castano A, Sanchez-Freire E, Benito Serrano ML, Ferrer Pascual C, Menacho I, Acosta-Rojas R, Cardona Gubert O, Farres Creus R, Armengol Alegre J, Martinez Querol C, Moreno-Martinez M, Gonfaus Font M, Narejos S, Gomez-Fernandez A. Assessing Patient-Reported Satisfaction With Care and Documentation Time in Primary Care Through AI-Driven Automatic Clinical Note Generation: Protocol for a Proof-of-Concept Study. JMIR Res Protoc. 2025 Apr 7;14:e66232. doi: 10.2196/66232.

Study Officials

  • Josep Vidal Alaball, MD, PhD

    Institut Català de la Salut / IDIAP Jordi Gol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2024

First Posted

October 1, 2024

Study Start

July 1, 2024

Primary Completion

December 31, 2024

Study Completion

January 30, 2025

Last Updated

February 21, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

Locations