Effectiveness of Using a Chatbot to Promote Adherence to Home Physiotherapy

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363137
• Other study ID #: NLP-PTAdherence
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2022
• Source: University of Valencia
• Contact: José M Blasco, PhD
• Phone: +34 963 98 38 55
• Email: jose.maria.blasco[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Chatbot Assistant
The physiotherpy treatment will be supervised via chatbot
• Standard care
The physiotherpy treatment will be standard care

Locations

Country	Name	City	State
Spain	Hospital La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Adverse events, defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study	Baseline (surgery day) to 12 months
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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