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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in functional status, as measured by the WOMAC Osteoarthritis Index, from baseline (pre-operative) to 14 days post-discharge.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Weeks 至 90 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: tele health (Other)
结局指标
主要结局
Change in functional status, as measured by the WOMAC Osteoarthritis Index, from baseline (pre-operative) to 14 days post-discharge.
时间窗: 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.
次要结局
- Change in self-care ability measured by the Self-Care Agency Scale(From baseline (preoperative assessment) to 14 days after discharge)
研究者
Rümeysa Demir
Lecturer
Sakarya Applied Sciences University