Clinical trial NCT06402539: Program Based on the Family-Centered Empowerment Model on Total Knee Prosthesis Patients and Their Caregivers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver
Keywords: total knee arthroplasty
Family Centered Empowerment Model
caregivers
care burden
self-efficacy
coping with stress
caregiving competence
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 TKA/THA-related postsurgical complications and hospital readmissions and associated medical costs (e.g., ∼$20,000 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.

Eligibility criteria: Inclusion Criteria: For patients :

* Being at least literate,
* Being 18 years or older,
* Ability to understand and speak Turkish,
* Having primary unilateral total knee arthroplasty surgery for the first time

The inclusion criteria for caregivers will be as follows:

* Volunteering for research,
* Being a relative of the patient (spouse, daughter, son-in-law, grandchild, daughter-in-law, son, brother, friend, etc.),
* Care for the patient for at least one month
* Being at least literate,
* Being 18 years or older,
* Ability to understand and speak Turkish,
* Being a caregiver to a patient with Total knee arthroplasty for the first time

Exclusion Criteria: for Patients

* Hearing and vision problems
* Mini mental test score below 25 points (less than 10 points indicate serious disorder, 10-19 points indicate moderate dementia, 19-24 points indicate early stage dementia).
* Having a communication problem such as vision or hearing that prevents the patient from understanding the information given and expressing it correctly.
* Having a diagnosed psychiatric disease

Exclusion Criteria for Caregivers

* Hearing and vision problems
* Mini mental test score below 25 points (less than 10 points indicate serious disorder, 10-19 points indicate moderate dementia, 19-24 points indicate early stage dementia).
* Having a communication problem such as vision or hearing that prevents the patient from understanding the information given and expressing it correctly.
* Having a diagnosed psychiatric disease,
* Providing paid care

Primary outcomes:
measure: Physiological function levels
timeFrame: Pre-test at the anesthesia clinic within 10 days before the surgery date. Post test on the 3rd day after surgery The last follow-up test was performed at the 4th week after surgery.
Secondary outcomes:
measure: Patient self-efficacy
timeFrame: Pre-test at the anesthesia clinic within 10 days before the surgery date. Post test on the 3rd day after surgery The last follow-up test was performed at the 4th week after surgery.
measure: Readmission to the hospital within 30 days after discharge
timeFrame: Pre-test at the anesthesia clinic within 10 days before the surgery date. Post test on the 3rd day after surgery The last follow-up test was performed at the 4th week after surgery.
measure: Care burden of caregivers
timeFrame: Pre-test at the anesthesia clinic within 10 days before the surgery date. Post test on the 3rd day after surgery The last follow-up test was performed at the 4th week after surgery.
measure: Caregiving competence
timeFrame: Pre-test at the anesthesia clinic within 10 days before the surgery date. Post test on the 3rd day after surgery The last follow-up test was performed at the 4th week after surgery.
measure: Coping Response Inventory Scale
timeFrame: Pre-test at the anesthesia clinic within 10 days before the surgery date. Post test on the 3rd day after surgery The last follow-up test was performed at the 4th week after surgery.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selçuk University Faculty of Medicine Hospital
state: Selçuklu
Study officials:
affiliation: Alanya Keykubat University
name: Şerife Kurşun Kural, PhD
role: STUDY_DIRECTOR
affiliation: Selcuk University
name: Fatma Taş Arslan, Professor
role: STUDY_DIRECTOR
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