Back to resultsEffectiveness of Using a Chatbot to Promote Adherence to Home Physiotherapy
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chatbot Assistant
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Hospital La FeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Outcomes
Primary Outcome Measures
Adherence
Compliance with intervention measured as the percentage of sessions carried out with respect to the total planned
Secondary Outcome Measures
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
Knee Pain
Measured with a visual analogue scale of pain, being 0 no pain and 10 the worst possible pain
Full Information
NCT ID
NCT05363137
First Posted
May 2, 2022
Last Updated
September 2, 2022
Sponsor
University of Valencia
Collaborators
Ministerio de Ciencia e Innovación, Spain
1. Study Identification
Unique Protocol Identification Number
NCT05363137
Brief Title
Effectiveness of Using a Chatbot to Promote Adherence to Home Physiotherapy
Official Title
Herramienta de Procesamiento de Lenguaje Natural en Dispositivo móvil Inteligente Para Fomentar la Adherencia a la rehabilitación Domiciliaria
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Ministerio de Ciencia e Innovación, Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Chatbot Assistant
Intervention Description
The physiotherpy treatment will be supervised via chatbot
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
The physiotherpy treatment will be standard care
Primary Outcome Measure Information:
Title
Adherence
Description
Compliance with intervention measured as the percentage of sessions carried out with respect to the total planned
Time Frame
Change from baseline to 3 months after surgery date
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
Time Frame
Change from baseline to 3 months and one year after surgery date
Title
Knee Pain
Description
Measured with a visual analogue scale of pain, being 0 no pain and 10 the worst possible pain
Time Frame
Change from baseline to 3 months and one year after surgery date
Other Pre-specified Outcome Measures:
Title
Safety
Description
Adverse events, defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study
Time Frame
Baseline (surgery day) to 12 months
Title
Feasibility_1
Description
Recruitment rate, obtained by dividing the number of participants divided by the number patients invited
Time Frame
Time from initial day to last day of recruitment up to two years
Title
Feasibility_2
Description
Retention rate, obtained by dividing the number of participants assessed at three months by the total number of participants
Time Frame
Time from initial day to 3 months after surgery date
Title
International Physical Activity Questionnaire (IPAQ-E)
Description
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
Time Frame
Change from baseline to 3 months after surgery date
Title
System Usability
Description
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
Time Frame
Change from baseline to 3 months after surgery date
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José M Blasco, PhD
Phone
+34 963 98 38 55
Ext
51313
Email
jose.maria.blasco@uv.es
Facility Information:
Facility Name
Hospital La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Roig, phd, PT
Email
sergio.roig@uv.es
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Using a Chatbot to Promote Adherence to Home Physiotherapy
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