Effect of A Program Based on A Family-Centered Empowerment Model on Total Knee Arthroplasty Patients and Their Caregivers: A Randomized Controlled Trial Protocol

ABSTRACT Background/Aims: The aim is to present the details of the content of the study evaluating the effects of the Family-Centered Empowerment Model (FCEM) program given to individuals who underwent Total Knee Arthroplasty (TKA) and their caregivers on the individuals' physiological function level, self-efficacy, post-discharge rehospitalization (during the follow-up period); the caregiver's care burden, caregiving competence, and stress coping. Methods:This study was designed as a randomized controlled experimental study and was registered with ClinicalTrials under the number NCT06402539. A total of 62 patients will be included in the study, including the intervention and control groups. Data will be collected using the Sociodemographic Characteristics Form, Postoperative Complication Development Form, Barthel Daily Living Activities Index, General Self-Efficacy Scale, Zarit Caregiver Burden, Caregiver Competence, and Stress Coping Scale. Patients in the intervention group will receive counseling 8 times for 5 weeks with a booklet structured according to FCEM. Patients in the control group will receive their standard care; at the last follow-up (30th day after surgery), the section on what to do after 30th day after surgery in the booklet will be provided. Results: The statistical analysis of the data obtained as a result of the research will be calculated using the SPSS 29 package program in a computer environment. For descriptive statistics, number, percentage, mean and standard deviation, chi-square analysis will be used to compare the similarity/homogeneity of the groups in terms of descriptive characteristics. The results obtained will be evaluated at the p<0.05 significance level. Conclusion: Our study protocol will guide subsequent research by providing details of the FCEM program.