Mobile Application Based Care for Total Knee Prosthesis Patients (KneeMobilApp)

April 3, 2024 updated by: Sinop University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Osmaniye Köyü
      • Merkez, Osmaniye Köyü, Turkey, 5700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score = KOOS
Time Frame: one day
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise of Self-Care Agency=ESCA
Time Frame: one day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinop University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sonay GÖKTAŞ, PhD, Consulting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SINOPU-elif 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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