Mobile Application Based Care for Total Knee Prosthesis Patients

NCT06346717 | Recruiting

• 1 other identifier: SINOPU-elif 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Prosthesis; Mobile Application

Keywords

Total Knee Prosthesis; Mobile Application; Nursing Care; Functional Status; Self-Care Power

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exercise of Self-Care Agency=ESCA

  one day

Study Arms (2)

Control Group

NO INTERVENTION

No intervention will be made to the patients in the control group (n = 30). Patients in the control group will receive standard care and discharge education provided by the hospital. Discharge training consists of verbal information about the postoperative period. The "MMD Scale" will be applied to patients who meet the criteria 1 day before the surgery. Patients with a "BCS Scale" ≥ 89 will be included in the study. Patients will be interviewed face to face and written consent will be obtained. Sociodemographic and descriptive data will be obtained with the "Descriptive Patient Form". Discharge day after surgery (3rd day); Functional status level will be measured with KOOS. 3rd and 6th weeks after surgery; Functional status and self-care ability levels will be measured using the KOOS and Self-Care Power Scale, respectively.

Experimental Group

EXPERIMENTAL

Patients assigned to the intervention group (n=30) will receive "Knee Prosthesis-M" mobile application service for iOS and Android devices, in addition to standard treatment. The "MMD Scale" will first be applied to patients who meet the criteria 1 day before the surgery. Patients with a "BCS Scale" ≥ 89 will be included in the study. Patients will be interviewed face to face and written consent will be obtained. Sociodemographic and descriptive data will be obtained with the "Descriptive Patient Form". The intervention group will also use the "Knee Prosthesis-M" mobile application for 6 weeks, starting from the 1st day of the surgery. Discharge day after surgery (3rd day); The level of functional status will be measured using the KOOS. At the 3rd and 6th weeks after surgery, functional status and self-care skills will be measured using the KOOS and Self-Care Power Scale, respectively.

Behavioral: "Knee Prosthesis-M" mobile application service

Interventions

"Knee Prosthesis-M" mobile application service BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinop University: lead

Study Sites (1)

Elif ALTINKAYNAK SARAL

Merkez, Osmaniye Köyü, 5700, Turkey (Türkiye)

RECRUITING

Study Officials

• Sonay GÖKTAŞ, PhD

  Consulting

  STUDY DIRECTOR

Central Study Contacts

Elif ALTINKAYNAK SARAL, PhD

CONTACT

05436071986; ealtinkynk@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: March 27, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)