Mobile Application Based Care for Total Knee Prosthesis Patients

Mobile Application Clinical Trial

— KneeMobilApp  

Official title:

The Effect of Mobile Application-Based Care on Functional Status And Self-Care Agency in Patients Undergoing Total Knee Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346717
• Other study ID #: SINOPU-elif 2
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2024
• Source: Sinop University
• Contact: Elif ALTINKAYNAK SARAL, PhD
• Phone: 05436071986
• Email: ealtinkynk[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total knee prosthesis (TKP); It is a surgical treatment used in the management of functional limitations and severe pain occurring on the degenerated joint surface as a result of rheumatoid arthritis, osteoarthritis, posttraumatic arthritis and other nonspecific arthritis. Nursing care is of great importance in the success of TKP surgery. Reducing pain, preventing complications, increasing self-care ability, and improving the quality of life by improving postoperative knee functions are the main goals of postoperative nursing care. In order to achieve these goals, patients and their relatives need to receive training on home care in the post-operative period before discharge. With the increasing use of mobile technologies in daily life and the increasing adoption of e-health, the opportunity for people to improve their self-management skills through e-health is increasing. Mobile Health (m-Health) provides convenience in many areas such as educating the public, warning about potential diseases and disease risks, and communicating with messages, notifications and video when necessary. It also affects the way nursing services are delivered and provides great benefits in the delivery of nursing services. For all these reasons, it was aimed to examine the effect of mobile application-supported care given to patients with total knee prosthesis on functional status and self-care ability.

Description:

The population of the research will consist of patients who underwent total knee prosthesis (TKP) surgery in Sinop Atatürk State Hospital Orthopedics and Traumatology Service between March 2024 and March 2025. The sample will consist of a total of 60 patients, 30 patients in the intervention group and 30 patients in the control group, who meet the inclusion criteria for the study. Patients who are 18 years of age or older, literate, have undergone unilateral total knee prosthesis for the first time, have a smartphone, have a score of 89 or above on the "Mobile Learning Readiness (MLD) Scale" and volunteer to participate in the study will be included in the study. Research data will be collected three times: on the day of discharge, 3rd week and 6th week after surgery, using the Descriptive Patient Form, Knee Injury and Osteoarthritis Outcome Score (KOOS) and Self-Care Power Scale. Individuals with TKP in the intervention group will be asked to use the Knee Prosthesis Mobile application (Knee Prosthesis-M) for six weeks. During this process, individuals with TKP in the control group will be ensured to receive standard care. All interviews will be conducted face to face.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Who are 18 years or older
• Being literate
• For the first time, unilateral total knee prosthesis was applied
• Having a smart phone
• Scoring 89 or above on the "Mobile learning readiness (MLD) scale"
• Patients who volunteer to participate in the study

Exclusion Criteria:

• Having speech, hearing and visual impairments
• Having a neurological medical diagnosis that affects cognitive status
• Patients with a psychiatric medical diagnosis
• Not using the mobile application at all
• Notification messages are turned off for 72 hours and cannot be reached by phone after this period
• Interrupting communication before data collection processes are completed
• Wanting to leave the study voluntarily

Related Conditions & MeSH terms

• Knee Prosthesis
• Mobile Application

Intervention

Behavioral:
• "Knee Prosthesis-M" mobile application service
In the early phase of mobile application development, qualitative interviews will be conducted with patients with total knee arthroplasty (TKA) experience regarding their own surgery experiences. A training booklet for "Knee prosthesis-M" will be created, taking into account the literature and patient feedback. Then, the "Knee prosthesis-M" application design will be completed. One day before surgery; Written consent will be obtained from patients who meet the criteria via an "Informed Consent Form". Patients in the intervention group will access the "Knee Prosthesis-M" application from their smartphones and will be asked to use it actively for 6 weeks, starting from the 1st day of the surgery. Mobile application-supported care will be provided to the patients by sending information, warning and reminder messages to the patients for 6 weeks.

Locations

Country	Name	City	State
Turkey	Elif ALTINKAYNAK SARAL	Merkez	Osmaniye Köyü

Sponsors (1)

Lead Sponsor	Collaborator
Sinop University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score = KOOS	It is a scale used to evaluate symptoms and functional status due to knee injuries and knee osteoarthritis. It has 5 subgroups: pain, other symptoms, functional status in daily living activities, functional status in sports and leisure activities, and knee-related quality of life. It consists of 42 questions that take approximately 10 minutes. A change of 10 points or more on each subscale between 0 and 100 indicates a clinically significant change. It has been reported to have good reliability and validity in patients undergoing joint replacement.	one day
Secondary	Exercise of Self-Care Agency=ESCA	The scale is organized as 35 items. The scale is based on four basic features: active and passive response across situations, motivation, knowledge of health practices, and the individual's own feelings and values. Individuals' answers to the self-care power scale were scored from 0 to 4 and evaluated according to the answers given on a 5-point Likert type scale. The answer "It doesn't describe me at all" was given 0 points, the answer "It doesn't describe me much" was given 1 point, the answer "I have no idea" was given 2 points, the answer "It describes me a little" was given 3 points, the answer "It describes me a lot" was given 4 points. There are 8 negative statements (3, 6, 9, 13, 19, 22, 26, 31) in the scale and the scoring is reversed. The highest score obtained from the scale is 140, and an increase in the score indicates that the individual's self-care power increases.	one day