Knee ProsthesisKneeMobilAppNCT06346717
Mobile Application Based Care for Total Knee Prosthesis Patients
A study testing "Knee Prosthesis-M" mobile application service in people with Knee Prosthesis and Mobile Application, run by Sinop University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Prosthesis, Mobile Application
- What is being tested?
- "Knee Prosthesis-M" mobile application service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Elif ALTINKAYNAK SARAL
Center, Osmaniye Köyü, 5700
ELİF ALTINKAYNAK SARAL, PhD, 05436071986, ealtinkynk@hotmail.com
Sonay GÖKTAŞ, PhD, 05324567776, sonay.goktas@sbu.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Prosthesis, Mobile Application
- Being tested
- "Knee Prosthesis-M" mobile application service
- Keywords
- Total Knee Prosthesis, Mobile Application, Nursing Care, Functional Status, Self-Care Power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Knee Prosthesis-M" mobile application serviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: "Knee Prosthesis-M" mobile application service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (1)
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start27 Mar 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonay GÖKTAŞ, PhD, Study director, Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346717
- Sponsor's protocol ID
- SINOPU-elif 2
- Acronym
- KneeMobilApp
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application-Based Care on Functional Status And Self-Care Agency in Patients Undergoing Total Knee Replacement
- ClinicalTrials.gov ID
- NCT06346717
- Acronym / sponsor ID
- KneeMobilApp / SINOPU-elif 2
- Conditions
- Knee Prosthesis, Mobile Application
- Keywords
- Total Knee Prosthesis, Mobile Application, Nursing Care, Functional Status, Self-Care Power
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: "Knee Prosthesis-M" mobile application servicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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"
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Knee Prosthesis-M" mobile application serviceIn 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. | Behavioural | Experimental Group |
Primary outcome
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.
1 secondary outcome
Exercise of Self-Care Agency=ESCA
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonay GÖKTAŞ, PhD study director
Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Knee Prosthesis-M" mobile application service in people with Knee Prosthesis and Mobile Application, run by Sinop University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif ALTINKAYNAK SARAL, PhD (05436071986, ealtinkynk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score = KOOS (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.