Program Based on the Family-Centered Empowerment Model on Total Knee Prosthesis Patients and Their Caregivers

NCT06402539 | Recruiting

• 1 other identifier: 584847
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver

Keywords

total knee arthroplasty; Family Centered Empowerment Model; caregivers; care burden; self-efficacy; coping with stress; caregiving competence

Outcome Measures

Primary Outcomes (1)

• Physiological function levels

  Barthel Index:This scale evaluates mobility status and stair climbing functions such as feeding, washing, self-care, dressing, defecation control, urinary control, going to the toilet, ability to move from bed to wheelchair, walking or being dependent on a wheelchair, and stair climbing on a scale of 5-15 points (depending on the question). It consists of a total of 10 items that rate patients (0-15 points in 5-point increments). In this scale, the score that can be received is between 0-100, the higher the score, the more independent the patient is from other people and can manage his own business (0-20 points are fully dependent, 21- 61 points highly dependent, 62-90 points moderately dependent, 91-99 points mildly dependent, 100 points completely independent)

  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 (5)

• Patient self-efficacy

  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.

• Readmission to the hospital within 30 days after discharge

  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.

• Care burden of caregivers

  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.

• Caregiving competence

  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.

• Coping Response Inventory Scale

  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.

Study Arms (2)

receiving family-centered care

EXPERIMENTAL

IIn this randomized controlled clinical study, family-centered empowerment program (FCEM) will be implemented as an intervention. A total of 8 times (6 times face-to-face in the hospital; 2 times by phone) for 5 weeks. The content of face-to-face sessions consists of family-centered assessment, structured information booklet and bedside care skills training. Patients will be given a patient care booklet as part of this intervention. The content of the booklet; TKA surgery, preoperative period, postoperative period postdischarge care (daily tasks, surgical site care, weight gain, diet, driving, exercises It will include information enriched with visual materials regarding prevention of complications at home. The other part of the booklet consists of encouraging caregivers to actively participate in managing their own health and to maintain health-promoting behaviors such as nutrition, exercise, stress management and emotional management.

Behavioral: family-centered empowerment program

waiting care group

NO INTERVENTION

Patients and families in the control group will be cared for according to the routine of the clinic and no intervention will be made.This group will be given a booklet on what to do after the last follow-up measurement, that is, after the 1st month post-operative check-up.

Interventions

family-centered empowerment program BEHAVIORAL

The intervention will be carried out face to face in the Orthopedics and Traumatology outpatient clinic, and some interviews will be held by phone. The first interview is on the day the patient will be approved in the anesthesia department, the second interview is when the patient is admitted to the ward, the third interview is after the surgery and the fourth interview is in the ward on the day of discharge, the fifth interview is by phone 1 week after discharge, the sixth interview is at the outpatient clinic when the patient comes for a check-up 2 weeks after discharge, and the seventh interview is at the time of discharge. The eighth interview will be held by phone in the 3rd week after discharge, and the eighth interview will be held in the outpatient clinic in the 4th week after discharge.

receiving family-centered care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selçuk University Faculty of Medicine Hospital

Konya, Selçuklu, 42130, Turkey (Türkiye)

RECRUITING

Related Publications (9)

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  PMID: 3181916 BACKGROUND

• Fields B, Rodakowski J, Leighton C, Feiler C, Minnier T, James AE. Including and Training Family Caregivers of Older Adults in Hospital Care: Facilitators and Barriers. J Nurs Care Qual. 2020 Jan/Mar;35(1):88-94. doi: 10.1097/NCQ.0000000000000400.

  PMID: 30889081 BACKGROUND

• Gutenbrunner C, Stievano A, Nugraha B, Stewart D, Catton H. Nursing - a core element of rehabilitation. Int Nurs Rev. 2022 Mar;69(1):13-19. doi: 10.1111/inr.12661. Epub 2021 Jan 28.

  PMID: 33506550 BACKGROUND

• Huang TT, Sung CC, Wang WS, Wang BH. The effects of the empowerment education program in older adults with total hip replacement surgery. J Adv Nurs. 2017 Aug;73(8):1848-1861. doi: 10.1111/jan.13267. Epub 2017 Mar 6.

  PMID: 28122161 BACKGROUND

• Longo UG, Matarese M, Arcangeli V, Alciati V, Candela V, Facchinetti G, Marchetti A, De Marinis MG, Denaro V. Family Caregiver Strain and Challenges When Caring for Orthopedic Patients: A Systematic Review. J Clin Med. 2020 May 16;9(5):1497. doi: 10.3390/jcm9051497.

  PMID: 32429398 BACKGROUND

• Manohar A, Cheung K, Wu CL, Stierer TS. Burden incurred by patients and their caregivers after outpatient surgery: a prospective observational study. Clin Orthop Relat Res. 2014 May;472(5):1416-26. doi: 10.1007/s11999-013-3270-6.

  PMID: 24005979 BACKGROUND

• McIsaac DI, Beaule PE, Bryson GL, Van Walraven C. The impact of frailty on outcomes and healthcare resource usage after total joint arthroplasty: a population-based cohort study. Bone Joint J. 2016 Jun;98-B(6):799-805. doi: 10.1302/0301-620X.98B6.37124.

  PMID: 27235523 BACKGROUND

• Mora-Traverso M, Molina-Garcia P, Prieto-Moreno R, Borges-Cosic M, Cruz Guisado V, Del Pino Algarrada R, Moreno-Ramirez P, Gomez-Jurado G, Gomez Tarrias C, Hidalgo Isla M, Jimenez Andres P, Linares Gago M, Lirola-Liebanas A, Mesa-Ruiz A, Munoz-Garach A, Salazar-Gravan S, Estevez-Lopez F, Martin-Matillas M, Ariza-Vega P. An m-Health telerehabilitation and health education program on physical performance in patients with hip fracture and their family caregivers: Study protocol for the ActiveHip+ randomized controlled trial. Res Nurs Health. 2022 Jun;45(3):287-299. doi: 10.1002/nur.22218. Epub 2022 Feb 11.

  PMID: 35148434 BACKGROUND

• Provencher V, Clemson L, Wales K, Cameron ID, Gitlin LN, Grenier A, Lannin NA. Supporting at-risk older adults transitioning from hospital to home: who benefits from an evidence-based patient-centered discharge planning intervention? Post-hoc analysis from a randomized trial. BMC Geriatr. 2020 Mar 2;20(1):84. doi: 10.1186/s12877-020-1494-3.

  PMID: 32122311 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Şerife Kurşun Kural, PhD

  Alanya Keykubat University

  STUDY DIRECTOR

• Fatma Taş Arslan, Professor

  Selcuk University

  STUDY DIRECTOR

Central Study Contacts

Yasemin Şara, MSc

CONTACT

05394622005; yasemin.gsz@gmail.com

Fatma Taş Arslan, PhD

CONTACT

fatmatas61@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 7, 2024
• Study Start: December 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)