- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 ((TKA-TELECARE))
January 28, 2026 updated by: Rümeysa Demir, Sakarya Applied Sciences University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- 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 Locations
-
-
Akyazı
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Sakarya, Akyazı, Turkey (Türkiye), 54400
- Sakarya University of Applied Sciences
-
-
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
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The Effect of Tele-Health Application on Functional Status, Self-Care Ability and Activities
To investigate the effect of telehealth services on functional status, self-care ability, and activities of daily living after total knee arthroplasty.
|
To investigate the effect of telehealth services on functional status, self-care ability, and activities of daily living after total knee arthroplasty.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From baseline (preoperative assessment) to 14 days after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-care ability measured by the Self-Care Agency Scale
Time Frame: From baseline (preoperative assessment) to 14 days after discharge
|
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.
|
From baseline (preoperative assessment) to 14 days after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
April 10, 2025
Primary Completion (Actual)
November 5, 2025
Study Completion (Actual)
November 15, 2025
Study Registration Dates
First Submitted
July 30, 2025
First Submitted That Met QC Criteria
January 28, 2026
First Posted (Actual)
February 2, 2026
Study Record Updates
Last Update Posted (Actual)
February 2, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SakaryaAppliedSciencesUni
- 2024/4 (Other Identifier: University of Health Sciences)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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.
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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