Web-Based Conversational Assistant After Total Knee Arthroplasty (CARE-TKA)
23 juli 2026 uppdaterad av: Wojciech Sroga
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
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This single-centre pragmatic randomized pilot trial will evaluate the feasibility and preliminary effectiveness of a web-based conversational postoperative assistant following primary total knee arthroplasty (TKA). Participants will be randomized in a 1:1 ratio to receive either standard postoperative care alone or standard care plus access to the conversational assistant for 6 weeks after surgery.
The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations. The primary outcome is overall patient satisfaction at 6 weeks. Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts, and postoperative complications. The study is designed to generate preliminary evidence to support the development of a larger definitive randomized controlled trial.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
Alicante
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Alcoy, Alicante, Spanien, 03803
- Hospital Universitario Virgen de los Lirios
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Kontakt:
- Wojciech Sroga, MD
- Telefonnummer: +34 648617730
- E-post: wstrauma@gmail.com
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Kontakt:
- E-post: wstrauma@gmail.com
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Huvudutredare:
- Wojciech Sroga, MD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention
Participants receive standard postoperative care plus access to a web-based conversational postoperative assistant for 6 weeks after primary total knee arthroplasty.
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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.
|
|
Inget ingripande: Control
Participants receive standard postoperative care without access to the web-based conversational postoperative assistant.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Overall Patient Satisfaction
Tidsram: 6 weeks after total knee arthroplasty
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Overall patient satisfaction measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates not satisfied at all and 10 indicates completely satisfied.
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6 weeks after total knee arthroplasty
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Intensity
Tidsram: 2 weeks and 6 weeks after total knee arthroplasty
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Pain intensity measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
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2 weeks and 6 weeks after total knee arthroplasty
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Exercise Adherence
Tidsram: During the first 6 weeks after total knee arthroplasty
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Exercise adherence assessed as the percentage of prescribed home exercise sessions completed, based on the participant's exercise diary.
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During the first 6 weeks after total knee arthroplasty
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Unplanned Healthcare Contacts
Tidsram: During the first 6 weeks after total knee arthroplasty
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Number of unplanned healthcare contacts related to the operated knee, including primary care visits, emergency department visits, outpatient consultations, and hospital readmissions.
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During the first 6 weeks after total knee arthroplasty
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Postoperative Complications
Tidsram: During the first 6 weeks after total knee arthroplasty
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Occurrence of postoperative complications related to the surgical procedure.
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During the first 6 weeks after total knee arthroplasty
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 mars 2027
Avslutad studie (Beräknad)
1 mars 2027
Studieregistreringsdatum
Först inskickad
23 juli 2026
Först inskickad som uppfyllde QC-kriterierna
23 juli 2026
Första postat (Faktisk)
28 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HGUVL-TKA-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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