NCT06070441

Brief Summary

This project continuing to study on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients, in this case, with cervical musculoskeletal injuries and pain. The use of digital technologies and media is an important option to complement in-person treatment and promote adherence to treatment at home. The research aims to verify whether the use of a Chatbot as a means of communication can produce improvements in patient adherence and clinical results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

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

September 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

September 29, 2023

Last Update Submit

November 5, 2024

Conditions

Keywords

Treatment adherenceNew technologiesBack pain

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Record of the number of sessions performed.

    0 weeks, 12 weeks

Secondary Outcomes (4)

  • Visual analogue scale (VAS)

    0 weeks, 12 weeks

  • Disability

    0 weeks, 12 weeks

  • Satisfaction scale with the treatment received

    12 weeks

  • Sistem usability scale

    12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Home exercise assisted with a chatbot

Other: EducationDevice: Chatbot

Control

ACTIVE COMPARATOR

Home exercise, usual care

Other: EducationOther: Home exercise, usual care

Interventions

One-week, three sessions in alternate days, outpatient supervised education on how to perform the exercises at home

ControlExperimental
ChatbotDEVICE

12 week- intervention consisting of messages with an explanatory video of each exercise indicating how to do it and how many repetitions to perform

Experimental

12 week- intervention. Printed sheets indicating how to exercises and how many repetitions to perform

Control

Eligibility Criteria

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

You may qualify if:

  • Over 18 years.
  • Diagnosis of cervical pain.
  • Indication of treatment through home exercises.
  • With a personal smartphone
  • Verbally confirms to have installed an instant messaging service or app, and accesses it at least 3 times a week

You may not qualify if:

  • No to sign the informed consent.
  • Not able to understand, read and write in the Spanish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Hernández Guillén

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Treatment Adherence and ComplianceBack Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • David Hernández-Guillén

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The interventor providing the education sessions will be blinded to group allocation The outcome assessor will be blinded to the intervention
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two arms study, experimental vs control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University teacher, PT, PhD

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 6, 2023

Study Start

November 10, 2023

Primary Completion

July 10, 2024

Study Completion

August 10, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations