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

Status

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

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.

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 (Actual)

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.
64

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 Locations

  • Turkey (Türkiye)
    • Akyazı
      • 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

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

  • 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

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.
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.
Other: tele health
To investigate the effect of telehealth services on functional status, self-care ability, and activities of daily living after total knee arthroplasty.
Other Names:
  • telehealt

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
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

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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sakarya Applied Sciences University

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.

General Publications

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.
April 10, 2025

Primary Completion (Actual)

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.
November 5, 2025

Study Completion (Actual)

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.
November 15, 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).
July 30, 2025

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.
January 28, 2026

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.
February 2, 2026

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.
February 2, 2026

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.
January 28, 2026

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.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 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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