NCT06313294

Brief Summary

Monitoring performed by a trained operator has proven to be useful and valued by patients after the use of continuous regional anesthesia. A health professional calls each patient to gather information about their recovery. However, this direct communication strategy requires time and resources, especially if many patients are involved. A modern and convenient approach involves the use of immediate communication technology for follow-up after a procedure. They may contain specific questions that patients can easily answer from their mobile devices. Automated text messages could be associated with greater convenience and ease for patients with response rates at least like the traditional method. Phone calls, on the other hand, may be less scalable and require more human resources. The objective of the project is to evaluate the feasibility of monitoring through automated electronic messaging by evaluating its usability using a validated scale in Spanish. response rate on the first day and adherence rate compared to that of the traditional method. Secondarily, adherence and differences in satisfaction will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 23, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

February 23, 2024

Last Update Submit

August 20, 2024

Conditions

Keywords

Anesthesia, RegionalRegional AnesthesiaContinuous Nerve BlockAmbulatoryOutpatient follow-up

Outcome Measures

Primary Outcomes (1)

  • Usability level of the tracking application

    To determine the level of usability of the application using the SUS scale developed by John Brooke in 1986. This scale consists of 10 Likert-type statements. To calculate the result, the statements have an answer that will be equivalent to 1, 2, 3, 4 or 5, depending on said answer. The answers to the odd and even statements are added and then subtracted 5 and 25, respectively. The sum of both results is subsequently multiplied by 2.5 to obtain a result that ranges from 0 to 100, with 64 being our cut-off point to consider it acceptable.

    1, 2 and 3 days after discharge.

Secondary Outcomes (2)

  • Patient satisfaction with Perception of Quality in Anesthesia

    1, 2 and 3 days after discharge.

  • Patient adherence

    1, 2 and 3 days after discharge.

Study Arms (2)

App Group

EXPERIMENTAL

In this group the patients will use the app for asking about related to pain, patient satisfaction and another complications.

Other: Tracking application app

Telephone interview group

ACTIVE COMPARATOR

In this group the patients will receive the calling by one member of the healthcare team asking items related to pain, patient satisfaction and another complications.

Other: Telephone interview

Interventions

An app will be implemented for mobile monitoring in patients who use continuous postoperative ambulatory regional analgesia.

App Group

Patients who use continuous postoperative outpatient regional analgesia will be followed up using the current traditional method of post-discharge telephone call.

Telephone interview group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective surgery with continuous ambulatory regional analgesia
  • Able to understand, use and operate a smartphone to view the mobile application
  • ASA I - II

You may not qualify if:

  • Ages under 17 or over 76 years
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 450881, Chile

Location

Related Publications (1)

  • Strange E, Altermatt FR, Caceres L, Morrison C, Cortes L, Sumonte N, Neyem A; FAR-UC Group. Postoperative follow-up by automated text messaging versus telephone call in outpatient care with continuous regional analgesia: a randomized controlled feasibility trial. Reg Anesth Pain Med. 2025 Sep 18:rapm-2025-106818. doi: 10.1136/rapm-2025-106818. Online ahead of print.

MeSH Terms

Conditions

Neuralgia

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Fernando Altermatt, MD

    Pontificia Universidad Catolica de Chile

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The research patients will be blind to the proposed intervention.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Participants will are assigned to one of two groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 15, 2024

Study Start

May 31, 2024

Primary Completion

August 9, 2024

Study Completion

August 13, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations