NCT07380724

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

July 30, 2025

Last Update Submit

January 28, 2026

Conditions

Keywords

Functional Status, Activities of Daily Living, Self-Care Ability, Telehealth, Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

    From baseline (preoperative assessment) to 14 days after discharge

Secondary Outcomes (1)

  • Change in self-care ability measured by the Self-Care Agency Scale

    From baseline (preoperative assessment) to 14 days after discharge

Study Arms (1)

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.

Other: tele health

Interventions

To investigate the effect of telehealth services on functional status, self-care ability, and activities of daily living after total knee arthroplasty.

Also known as: telehealt
The Effect of Tele-Health Application on Functional Status, Self-Care Ability and Activities

Eligibility Criteria

Age40 Weeks - 90 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University of Applied Sciences

Sakarya, Akyazı, 54400, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 30, 2025

First Posted

February 2, 2026

Study Start

April 10, 2025

Primary Completion

November 5, 2025

Study Completion

November 15, 2025

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations