Viewing Study NCT06402539



Ignite Creation Date: 2024-05-11 @ 8:30 AM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06402539
Status: RECRUITING
Last Update Posted: 2024-05-07
First Post: 2024-04-16

Brief Title: Program Based on the Family-Centered Empowerment Model on Total Knee Prosthesis Patients and Their Caregivers
Sponsor: Selcuk University
Organization: Selcuk University

Study Overview

Official Title: The Effect of a Program Based on the Family-Centered Empowerment Model on Total Knee Prosthesis Patients and Their Caregivers Randomized Controlled Study
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In this study the family empowerment model program given to individuals who underwent Total Knee Prosthesis and their caregivers was examined on the individuals physiological function level self-efficacy and post-discharge hospital readmission during the follow-up period It was aimed to determine the effect of caregivers on their care burden caregiving competence and ability to cope with stress The population of the research will consist of patients who underwent FFP surgery at Selçuk University Hospital Orthopedics and Traumatology Clinic between December 2023 and June 2024 and people who were cared for by the same family member for at least one month The sample of the study will consist of patients and their caregivers who meet the inclusion criteria for the study The sample of the study will consist of a total of 62 patients and their caregivers who were admitted to the clinic on the dates mentioned above and meet the inclusion criteria for the study Study data will begin in the outpatient clinic and will be collected during the follow-up period until the 5th week after the patient is discharged A training booklet created according to the Family-Centered Empowerment Model and a total of 9 sessions containing training and counseling will be applied to the intervention group of the study Patients and families in the control group will be cared for according to the routine of the clinic and no intervention will be made The data obtained will be analyzed using the IBM SPSS 25 Statistical Packages for the Social Sciences - Undergraduate Selçuk University package program Ethical principles will be observed at every stage of the study
Detailed Description: Family involvement in perioperative education is beneficial to improve postoperative recovery outcomes and caregivers experiences of patients after Total Knee or Hip Arthroplasty Since patients are dependent on family members to meet their care needs immediately after discharge from the hospital after prosthetics these individuals need to be equipped with sufficient knowledge and practical skills through education Family members who provide quality care during recovery can contribute to reducing TKATHA-related postsurgical complications and hospital readmissions and associated medical costs eg 20000 per revision surgery

In 2004 the Institute for Family Centered Care IPFCC defined family-centered care as mutually beneficial partnerships between healthcare providers patients and families in healthcare planning delivery and evaluation Family-centered care has taken its place in the literature as a care model recommended to meet the needs of not only the patient but also the family members The Family Centered Empowerment Model FCEM helps plan implement and evaluate healthcare services through mutual partnerships of patients and families Family-centered empowerment provides opportunities for family caregivers to gain knowledge and skills so that they can best manage family life and ultimately improve the lifestyles and quality of life of all family members FCEM emphasizes individual agency and the role of other family members in three dimensions motivational psychological self-esteem and self-control and problematic individual characteristics knowledge attitudes and perceived threat Family empowerment has three main characteristics including the ability to review necessary educational resources the ability to make decisions and problem-solve and the ability to communicate to meet current needs Nurses play an important role by actively listening through reflective interaction to improve patients understanding of their situation problem-solving abilities and control of their lives Therefore FCEM components are included in the nursing process FCEM includes four main steps 1 threat perception 2 self-efficacy 3 self-esteem and 4 evaluation Therefore to achieve the best outcome FCEM is expected to simultaneously increase knowledge skills values and self-confidence and self-control beliefs in patients and their families Studies have shown that ongoing education and empowerment of primary caregivers can significantly reduce patient readmission and mortality

The effects of FCEM have been studied in various diseases It has been proven that AMGM administration can improve the lifestyles of patients with heart failure The effects of FCEM on reducing the care burden of caregivers of children with epilepsy and reducing perceived threats in heart failure patients have also been confirmed However only one study was found regarding the impact of using this model on caregivers of TKA and their family members The results of this research show that adopting FCEM increases patient motivation and self-care effectiveness promotes recovery of knee function in the short term after surgery and reduces the likelihood of complications There are gaps in the literature regarding the general experience and educational needs of family members of patients with TKA First previous research on caregivers experiences has mostly used quantitative research methods and focused on caregiver burden Secondly it is thought that caregivers should be included in the research process to better understand the impact of TKA surgery on the caregivers of these patients To improve the caregiving experience and ensure quality patient care training that directly targets the needs of family caregivers should be implemented There is limited research on supports such as family caregiver training or empowerment program after TKA

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None