Effectiveness of Using a Chatbot to Promote Adherence to Home Physiotherapy

Herramienta de Procesamiento de Lenguaje Natural en Dispositivo móvil Inteligente Para Fomentar la Adherencia a la rehabilitación Domiciliaria

A Chatbot oriented to virtually assist patients in a physiotherapy treatment has been designed and developed to interact with patients with musculoskeletal disorders in need for domiciliary rehabilitation. The tool has been designed to promote adherence to rehabilitation, what in turn may have an impact on clinical outcome. A randomized clinical trial involving patients undergoing total knee replacement has bee designed to determine the applicability of the proposal. The participants will be assigned into exerimental group (intervention with the software tool) or control group (standard care).

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Chatbot Assistant; Other: Standard care

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: José M Blasco, PhD; Phone Number: 51313 +34 963 98 38 55; Email: jose.maria.blasco@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital La Fe
    • Contact: Sergio Roig, phd, PT; Email: sergio.roig@uv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals on the waiting list for total knee replacement surgery
• Undergoing primary total knee replacement surgery
• Who have a personal smartphone
• Who have an instant messaging application installed
• Familiar with the use of such application (more than 3 accesses per week),

Exclusion Criteria:

• Evident cognitive state that prevents to understand care provider instructions
• Vestibular or central nervous system affection (e.g. stroke)
• Cannot read or write
• Do not understand Spanish language
• Not able to consent to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control	Other: Standard care; The physiotherpy treatment will be standard care
EXPERIMENTAL: Experimental	Other: Chatbot Assistant; The physiotherpy treatment will be supervised via chatbot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Compliance with intervention measured as the percentage of sessions carried out with respect to the total planned	Change from baseline to 3 months after surgery date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Self-administered questionnaire consisting of 24 items divided into pain, stiffness and physical function will register self-reported status. The score is given from 0 to 100	Change from baseline to 3 months and one year after surgery date
Knee Pain	Measured with a visual analogue scale of pain, being 0 no pain and 10 the worst possible pain	Change from baseline to 3 months and one year after surgery date

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse events, defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study	Baseline (surgery day) to 12 months
Feasibility_1	Recruitment rate, obtained by dividing the number of participants divided by the number patients invited	Time from initial day to last day of recruitment up to two years
Feasibility_2	Retention rate, obtained by dividing the number of participants assessed at three months by the total number of participants	Time from initial day to 3 months after surgery date
International Physical Activity Questionnaire (IPAQ-E)	This questionnaire is used to measure the types of intensity of physical activity and sitting time as part of the participants' daily lives, i.e. the total physical activity in MET-min/week and time spent sitting	Change from baseline to 3 months after surgery date
System Usability	System usability scale will be used for measuring the usability; this consists of a 10 item questionnaire with five response options from Strongly agree to Strongly disagree	Change from baseline to 3 months after surgery date

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Ministerio de Ciencia e Innovación, Spain

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (ACTUAL): May 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: NLP-PTAdherence

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No