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Completed

NCT Number: 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

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.

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Key information

Conditions

Total Knee Arthroplasty Self-Care Ability Telehealth

Age range

40 week–90 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University of Applied Sciences

Sakarya, Akyazı, 54400, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tele health

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sakarya Applied Sciences University

Other

Registry information

Official study 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

Acronym: (TKA-TELECARE)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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