NCT06306027

Brief Summary

The knee joint, which we use actively every day, is the largest joint in our body that bears the weight, allowing various movements such as walking, running, squatting, and standing. It involves the largest load-bearing structures in the body, including bones, cartilage, surrounding muscles, and ligaments, facilitating the mobilization of the joint. Due to constant use, the knee joint is susceptible to injuries and wear. Total knee arthroplasty (TKA) surgery involves replacing a degenerated joint surface, often due to conditions like osteoarthritis or rheumatoid arthritis, with a metal or polyethylene prosthesis. TKA, a widely used and highly successful surgical intervention in recent years, reduces pain, enhances functional range of motion, and improves independence and quality of life. Severe pain following TKA surgery restricts the movement of the knee joint and daily life activities, leading to the patient's inadequacy in self-care. Patients undergoing TKA surgery often face a lack of information after discharge. This lack of knowledge, coupled with uncertainty about the disease, limits the patient's self-efficacy. As the self-care power diminishes for patients struggling with daily life activities, their self-efficacy is negatively affected. The continuity of education becomes crucial since the verbal and written instructions given after surgery may not be sustained, causing a gradual decline in an individual's self-efficacy. As seen in the literature, studies have shown that postoperative pain, swelling, joint stiffness, fear, and movement limitations negatively impact the quality of life for patients undergoing TKA. Consequently, the self-care capacity, self-efficacy levels, and quality of life for individuals who have undergone TKA are adversely affected, as indicated in the literature.Ensuring continuity of care at home is crucial not only during the early postoperative period in the clinic but also after discharge. The nurse plays a significant role as an educator/advisor after discharge. The nurse provides counseling to patients discharged after Total Knee Arthroplasty (TKA) on pain management, disease progression, rehabilitation process, exercises, and considerations during daily activities (such as walking, bathing, toileting). Additionally, the nurse offers guidance on late-stage complications that may arise at home due to surgery and situations requiring hospitalization. While web-based educational interventions have been conducted for various patient groups, a web-based education program specifically for TKA surgery has not been identified. Having web-based post-TKA patient education allows continuous monitoring, assesses attendance and effectiveness remotely, and enables individuals to convey requests and questions to researchers through live support, ultimately enhancing the effectiveness of education. This approach is believed to prevent complications, reduce patient care costs and readmissions, increase patients' self-sufficiency in self-care, and consequently elevate their self-efficacy levels and quality of life. Close monitoring of postoperative patients is expected to improve their quality of life and self-care abilities, leading to increased satisfaction with healthcare services.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

February 2, 2024

Last Update Submit

March 4, 2025

Conditions

Keywords

Web-Based EducationSelf-EfficacyQuality of LifeSelf Care PowerKnee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Personal Information Form

    The personal information form has been created by researchers based on a literature review. This form includes a total of 14 questions covering sociodemographic and introductory characteristics of the patient, such as age, gender, weight, height, BMI, marital status, education level, occupation, employment status, cohabitants, presence of chronic diseases, regularly used medications, and the status of receiving discharge education.

    1 Minutes

Secondary Outcomes (1)

  • Self-Care Power Scale

    3 Minutes

Other Outcomes (2)

  • Self-Efficacy - Competence Scale

    2 Minutes

  • Short Form 36 Quality of Life Scale

    4 Minutes

Study Arms (2)

Experimental

EXPERIMENTAL

When patients come to the polyclinic for a check-up 15 days after discharge, the web-designed training program site will be promoted. The patient who accepts the research will be given a user name and password specifically created by the researcher. The patient will be explained practically how to log in to the system at home via phone. Patients will be asked to watch educational videos on the website at least twice a week for one month. Then, pre-test data, Personal Information Form, Self-Efficacy Scale, Self-Care Power Scale and Quality of Life Scale data will be collected. Patients who receive training for a month will be asked to fill out the self-efficacy scale, self-care power scale and quality of life scale for post-test data via the mobile application at the end of the month.

Behavioral: Web-based education

Control Group

NO INTERVENTION

When patients come to the outpatient clinic for a check-up 15 days after discharge, they will be asked to fill out the Personal Information Form, Self-Efficacy Scale, Self-Care Ability Scale, and Quality of Life Scale by face-to-face information collection method.Patients will receive routine treatment, care and checks in line with the institutional policy. A web designed training program will not be implemented. One month after the pre-test data is collected, patients will be called and asked to fill out the self-efficacy scale, self-care ability scale and quality of life scale when they come to the outpatient clinic.

Interventions

The patient discharged after knee arthroplasty surgery will attend a follow-up appointment 15 days later, and during this visit, they will be granted permission to resume work. The patient will receive detailed information about accessing, entering, and using the web-based training. Scales with pre-test data will be completed by the patient. They will be encouraged to log in at least twice a week, and the patient will be monitored for a total of 1 month (4 weeks). After one month, the patient will be asked to fill out the scales again.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years or older
  • First time performing Total Knee Arthroplasty
  • Ability to access the internet via smart phone, tablet, computer
  • Must have the ability to use smart phones and tablets
  • Ability to read and understand Turkish
  • No mental, psychiatric or neurological disability

You may not qualify if:

  • Complications develop in the patient during the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location

Study Officials

  • Serap SAYAR, PhD

    KTO Karatay University

    STUDY DIRECTOR
  • Esra Nur BOZTAŞ, MScN

    Konya City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

February 2, 2024

First Posted

March 12, 2024

Study Start

March 1, 2024

Primary Completion

October 30, 2024

Study Completion

January 10, 2025

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The researcher at Konya City Hospital will collect the data.

Locations