Total Knee Arthroplasty(TKA-TELECARE)NCT07380724
The Effect of Tele-Health Application on Functional Status, Self-Care Ability and Activities of Daily Living in Individuals Undergoing Total Knee Arthroplasty Surgery
A study testing tele health in people with Total Knee Arthroplasty and Telehealth, run by Sakarya Applied Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis, defined as a degenerative joint disease, is a chronic, non-inflammatory condition characterized by deterioration of joint cartilage and new bone formation on joint surfaces and margins. Due to osteoarthritis, the number of total knee arthroplasty (TKA) procedures has increased. Read more about this study
- Who is it for?
- Ages 40 to 90 weeks
- Conditions the study is for
- Total Knee Arthroplasty, Telehealth, Self-Care Ability
- What is being tested?
- tele health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 15 Nov 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 40 to 90 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 40 years or older
- Undergoing primary total knee arthroplasty due to osteoarthritis
- Able to communicate verbally and use a telephone or mobile device
- Discharged to home (not transferred to rehabilitation or nursing facility)
- Volunteering to participate and providing informed consent
- Having cognitive competence to answer questionnaires and follow instructions
- Access to a mobile phone or internet connection at home for telehealth follow-up
Who cannot join
- Undergoing revision knee arthroplasty or bilateral knee arthroplasty
- Having significant hearing, visual, or cognitive impairment that interferes with communication
- Diagnosed with advanced neurological or psychiatric disorders
- Having a severe postoperative complication (e.g., deep infection, reoperation)
- Being enrolled in another intervention study simultaneously
- Residing in a long-term care facility or nursing home
- Unable or unwilling to participate in telehealth-based interventions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University of Applied Sciences
Sakarya, Akyazı, 54400
About this study
Official title: The Effect of Telehealth-Based Follow-Up on Functional Status, Self-Care Ability, and Activities of Daily Living in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
Osteoarthritis, defined as a degenerative joint disease, is a chronic, non-inflammatory condition characterized by deterioration of joint cartilage and new bone formation on joint surfaces and margins. Due to osteoarthritis, the number of total knee arthroplasty (TKA) procedures has increased. Patients undergoing TKA often experience difficulties in meeting their self-care needs and performing daily living activities due to impaired functional status. During the postoperative home care period, nursing support is critical in enhancing patients' functional status, self-care ability, and independence in daily activities. Therefore, this study aims to examine the effect of telehealth services on functional status, self-care ability, and daily living activities in patients undergoing TKA. The study is designed as a randomized controlled trial. The sample will consist of patients who undergo TKA in the Orthopedics and Traumatology Department of Sakarya University Training and Research Hospital between April 2024 and April 2025. Patients in the intervention group will receive telehealth-based nursing follow-up, including education and counseling for 14 days after discharge. The control group will receive only standard discharge education. Data will be collected using the Structured Patient Information Form, WOMAC Osteoarthritis Index, Self-Care Agency Scale, Barthel Index of Activities of Daily Living, Subcutaneous Heparin Injection Evaluation Form, and Telephone Interview Form. Based on power analysis, a total of 54 participants are needed to achieve 85% power at a 95% confidence level and medium effect size (p < 0.05). To account for potential data loss, the sample size was increased to 60. It is anticipated that utilizing telehealth services for postoperative nursing follow-up will contribute significantly to patient safety, healthcare costs, and the nursing discipline.
- Conditions
- Total Knee Arthroplasty, Telehealth, Self-Care Ability
- Being tested
- tele health
- Keywords
- Functional Status, Activities of Daily Living, Self-Care Ability, Telehealth, Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele healthOther
Also called telehealt
To investigate the effect of telehealth services on functional status, self-care ability, and activities of daily living after total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| The Effect of Tele-Health Application on Functional Status, Self-Care Ability and Activities | Experimental | To investigate the effect of telehealth services on functional status, self-care ability, and activities of daily living after total knee arthroplasty. Receives: Other: tele health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional status, as measured by the WOMAC Osteoarthritis Index, from baseline (pre-operative) to 14 days post-discharge.
Functional status will be assessed using the WOMAC Osteoarthritis Index, which evaluates pain, stiffness, and physical function. Scores will be recorded at baseline (before surgery) and at the end of a 14-day telehealth-based follow-up period post-discharge.
Measured: From baseline (preoperative assessment) to 14 days after discharge
Secondary outcomes (1)
Change in self-care ability measured by the Self-Care Agency Scale
Self-care ability will be assessed using the Self-Care Agency Scale. The scale evaluates the individual's capacity to meet their own self-care needs. Scores will be obtained before surgery and after the 14-day telehealth follow-up period.
Measured: From baseline (preoperative assessment) to 14 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start10 Apr 2025
- Primary completion5 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya Applied Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rümeysa Demir, Sakarya Applied Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380724
- Sponsor's protocol ID
- SakaryaAppliedSciencesUni
- Other IDs
- 2024/4
- Acronym
- (TKA-TELECARE)
- Status last verified
- Jan 2026
- First submitted
- 30 Jul 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will not be shared because the study involves sensitive patient information and data confidentiality must be maintained in accordance with ethical and institutional guidelines.
Publications
Tsang MP, Man GCW, Xin H, Chong YC, Ong MT, Yung PS. The effectiveness of telerehabilitation in patients after total knee replacement: A systematic review and meta-analysis of randomized controlled trials. J Telemed Telecare. 2024 Jun;30(5):795-808. doi: 10.1177/1357633X221097469. Epub 2022 May 12.
PubMed 35549756
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telehealth-Based Follow-Up on Functional Status, Self-Care Ability, and Activities of Daily Living in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07380724
- Acronym / sponsor ID
- (TKA-TELECARE) / SakaryaAppliedSciencesUni
- Conditions
- Total Knee Arthroplasty, Telehealth, Self-Care Ability
- Keywords
- Functional Status, Activities of Daily Living, Self-Care Ability, Telehealth, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sakarya Applied Sciences UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 2 Feb 2026 (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.
Osteoarthritis, defined as a degenerative joint disease, is a chronic, non-inflammatory condition characterized by deterioration of joint cartilage and new bone formation on joint surfaces and margins. Due to osteoarthritis, the number of total knee arthroplasty (TKA) procedures has increased. Patients undergoing TKA often experience difficulties in meeting their self-care needs and performing daily living activities due to impaired functional status. During the postoperative home care period, nursing support is critical in enhancing patients' functional status, self-care ability, and independence in daily activities. Therefore, this study aims to examine the effect of telehealth services on functional status, self-care ability, and daily living activities in patients undergoing TKA. The study is designed as a randomized controlled trial. The sample will consist of patients who undergo TKA in the Orthopedics and Traumatology Department of Sakarya University Training and Research Hospital between April 2024 and April 2025. Patients in the intervention group will receive telehealth-based nursing follow-up, including education and counseling for 14 days after discharge. The control group will receive only standard discharge education. Data will be collected using the Structured Patient Information Form, WOMAC Osteoarthritis Index, Self-Care Agency Scale, Barthel Index of Activities of Daily Living, Subcutaneous Heparin Injection Evaluation Form, and Telephone Interview Form. Based on power analysis, a total of 54 participants are needed to achieve 85% power at a 95% confidence level and medium effect size (p < 0.05). To account for potential data loss, the sample size was increased to 60. It is anticipated that utilizing telehealth services for postoperative nursing follow-up will contribute significantly to patient safety, healthcare costs, and the nursing discipline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Effect of Tele-Health Application on Functional Status, Self-Care Ability and Activities | Experimental | Other: tele healthTo investigate the effect of telehealth services on functional status, self-care ability, and activities of daily living after total knee arthroplasty. |
Who may qualify
- Ages
- 40 to 90 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 40 years or older
- Undergoing primary total knee arthroplasty due to osteoarthritis
- Able to communicate verbally and use a telephone or mobile device
- Discharged to home (not transferred to rehabilitation or nursing facility)
- Volunteering to participate and providing informed consent
Key exclusion criteria (7 listed)
- Undergoing revision knee arthroplasty or bilateral knee arthroplasty
- Having significant hearing, visual, or cognitive impairment that interferes with communication
- Diagnosed with advanced neurological or psychiatric disorders
- Having a severe postoperative complication (e.g., deep infection, reoperation)
- Being enrolled in another intervention study simultaneously
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 |
|---|---|---|
| tele healthAlso: telehealtTo investigate the effect of telehealth services on functional status, self-care ability, and activities of daily living after total knee arthroplasty. | Other | The Effect of Tele-Health Application on Functional Status, Self-Care Ability and Activities |
Primary outcome
Change in functional status, as measured by the WOMAC Osteoarthritis Index, from baseline (pre-operative) to 14 days post-discharge.
Time frame: From baseline (preoperative assessment) to 14 days after discharge
Functional status will be assessed using the WOMAC Osteoarthritis Index, which evaluates pain, stiffness, and physical function. Scores will be recorded at baseline (before surgery) and at the end of a 14-day telehealth-based follow-up period post-discharge.
1 secondary outcome
Change in self-care ability measured by the Self-Care Agency Scale
Time frame: From baseline (preoperative assessment) to 14 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 35549756Tsang MP, Man GCW, Xin H, Chong YC, Ong MT, Yung PS. The effectiveness of telerehabilitation in patients after total knee replacement: A systematic review and meta-analysis of randomized controlled trials. J Telemed Telecare. 2024 Jun;30(5):795-808. doi: 10.1177/1357633X221097469. Epub 2022 May 12.
- Individual participant dataSharing planned: Undecided. IPD will not be shared because the study involves sensitive patient information and data confidentiality must be maintained in accordance with ethical and institutional guidelines.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele health in people with Total Knee Arthroplasty and Telehealth, run by Sakarya Applied Sciences 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 7 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: finished, as of the sponsor's last update on 2 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional status, as measured by the WOMAC Osteoarthritis Index, from baseline (pre-operative) to 14 days post-discharge. (time frame: From baseline (preoperative assessment) to 14 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07380724, which also lists 1 linked publication.
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 2 Feb 2026.