Mobile Application Based Care for Total Knee Prosthesis Patients

NCT ID: NCT06346717

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-27

Study Completion Date

2025-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Prosthesis Mobile Application

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group

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.

Group Type EXPERIMENTAL

"Knee Prosthesis-M" mobile application service

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sinop University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sonay GÖKTAŞ, PhD

Role: STUDY_DIRECTOR

Consulting

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Elif ALTINKAYNAK SARAL

Merkez, Osmaniye Köyü, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Elif ALTINKAYNAK SARAL, PhD

Role: CONTACT

05436071986

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ELİF ALTINKAYNAK SARAL, PhD

Role: primary

05436071986

Sonay GÖKTAŞ, PhD

Role: backup

05324567776

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SINOPU-elif 2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.