Web-Based Conversational Assistant After Total Knee Arthroplasty
CARE-TKA
Evaluation of a Web-Based Conversational Postoperative Assistant on Patient Satisfaction and Exercise Adherence After Total Knee Arthroplasty: Protocol of a Pragmatic Randomized Pilot Study With 6-Week Follow-up
1 other identifier
interventional
60
1 country
1
Brief Summary
Total knee arthroplasty (TKA) is one of the most frequently performed elective orthopaedic procedures. Following hospital discharge, patients must manage pain, wound care and home rehabilitation with limited professional support. This pragmatic randomised pilot trial will evaluate whether a web-based conversational postoperative assistant, used in addition to standard care, improves patient satisfaction and exercise adherence during the first 6 weeks after TKA. Forty to sixty patients undergoing primary elective TKA will be randomised 1:1 to standard care with or without access to the conversational assistant. The primary outcome is overall patient satisfaction at 6 weeks. Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts and postoperative complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Shorter than P25 for not_applicable
1 active site
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
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
Study Completion
Last participant's last visit for all outcomes
March 1, 2027
July 28, 2026
July 1, 2026
5 months
July 23, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Patient Satisfaction
Overall patient satisfaction measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates not satisfied at all and 10 indicates completely satisfied.
6 weeks after total knee arthroplasty
Secondary Outcomes (4)
Pain Intensity
2 weeks and 6 weeks after total knee arthroplasty
Exercise Adherence
During the first 6 weeks after total knee arthroplasty
Unplanned Healthcare Contacts
During the first 6 weeks after total knee arthroplasty
Postoperative Complications
During the first 6 weeks after total knee arthroplasty
Study Arms (2)
Intervention
EXPERIMENTALParticipants receive standard postoperative care plus access to a web-based conversational postoperative assistant for 6 weeks after primary total knee arthroplasty.
Control
NO INTERVENTIONParticipants receive standard postoperative care without access to the web-based conversational postoperative assistant.
Interventions
Participants assigned to the intervention group receive access to a web-based conversational assistant for 6 weeks after primary total knee arthroplasty. The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations. It is available on demand and complements, but does not replace, standard postoperative care.
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Primary, unilateral, elective total knee arthroplasty (TKA).
- Discharged to home following surgery.
- Ability to use a smartphone or tablet with internet access (patient or caregiver).
- Written informed consent provided.
You may not qualify if:
- Revision or bilateral simultaneous TKA.
- Major postoperative complication precluding home discharge (e.g., admission to intensive care, unplanned return to theatre, or haemodynamic instability).
- Severe cognitive impairment precluding informed consent or device use.
- No access to an internet-enabled device.
- Inability or refusal to complete follow-up.
- Participation in another interventional study at enrolment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wojciech Srogalead
Study Sites (1)
Hospital Universitario Virgen de los Lirios
Alcoy, Alicante, 03803, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study. Participants and investigators are aware of the assigned intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 23, 2026
First Posted
July 28, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
July 28, 2026
Record last verified: 2026-07