NCT05088551

Brief Summary

The reasons such as the advanced age of most patients with Total Knee Arthroplasty (TKA), the presence of concomitant diseases, and bilateral prostheses cause a decrease in the quality of life by negatively affecting the healing processes of the patients. Patients who try to adapt to the problems experienced during postoperative recovery need the information to develop coping behaviors. Nurses play a crucial role in ensuring adequate and effective access of information to the patient during this challenging process, which significantly affects mobility and, consequently, life activities. Effective educational interventions to be implemented by nurses enable patients to make decisions about health problems and act to improve their quality of life. However, for patient education to be efficient, the information given must be easy to read, understandable, and suitable for various learning styles to cope with problems more effectively. Still, individuals with low health literacy have problems benefiting from all services provided, exceptionally patient education, at the desired level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

September 4, 2021

Last Update Submit

October 9, 2021

Conditions

Keywords

Total knee arthroplastyPatient educationNursingHealth literacyQuality of life

Outcome Measures

Primary Outcomes (1)

  • The Quality of Life Scale Change (SF-36)

    The Quality of Life Scale (SF-36), one of the most used scales to measure quality of life; It is a self-assessment scale that can be filled in a short time and is highly sensitive.While applying the scale, individuals are asked to answer considering the last 4 weeks. The scale consists of 36 questions and 8 sub-parameters (body pain, limitation due to physical problems, limitation due to mental problems, mental well-being, fatigue, general health perception, social function and physical function). In scoring, each parameter is evaluated between 0 and 100 points. A score of 0 indicates poor health, and a score of 100 indicates good health. The higher the score, the higher the quality of life.

    1st day of admission to the clinic change the quality of life score at before intervention, change from baseline the quality of lıfe score at 3 days, change from baseline the quality of life score at 6 weeks

Secondary Outcomes (1)

  • The Function Evaluation Form Change

    1st day of admission to the clinic change the function evaluation score at before intervention, change from baseline the function evaluation score at 3 days, change from baseline the function evaluation score at 6 weeks

Study Arms (2)

Control group

NO INTERVENTION

When the patients were admitted to the clinic,and the face-to-face interview method and the Patient Information Form,Turkey Health Literacy Scale-32,Patient Learning Needs Scale,Functional Assessment Form and Quality of Life Scale Form were filled.The second interview was conducted on the second or third day after the surgery, just before the patients were discharged.The Functional Assessment Form,Discharge Data Collection Form, and Quality of Life Questionnaire were applied.The third interview was performed 15 days after the surgery when the patients came for control or by phone.The 15th Day Recovery Process Data Collection Form were applied.The last interview was carried out six weeks after the surgery,either face-to-face or by phone,and the Functional Assessment Form,6th Week Post-Discharge Recovery Process Data Collection Form,and Quality of Life Questionnaire were applied again.Except for the routine practices of the service,no intervention was made to the control group patients.

Intervention group

EXPERIMENTAL

Unlike the control group, the intervention group was given the education plan prepared by the researcher after filling out the forms when the patients were first encountered, and the education was carried out using various training methods such as lecture, question-answer, demonstration, and practice.Patients whose check-up time after discharge was nearing (15 days after the operation) were called a few days before and their visit time was learned. The forms were filled in by interviewing the patients face-to-face by the researcher on the 15th day and the 6th week after the operation or making a phone call on the same day with the patients who could not be reached.

Other: Patient Education

Interventions

The education was divided into three parts. The information in the first part of the booklet (general information, preoperative preparation, and operation day) is given in the preoperative period. In the postoperative period, the patients were visited and the information in the second part (postoperative hospital stay, first, second, and third-day goals after surgery) was given. Before the patients were discharged, the information in the third section (things to be considered in the recovery process at home) was presented. According to the physical conditions of the clinic, patient education was carried out in an area suitable for teaching as much as possible.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years
  • Patients who had undergone total knee arthroplasty surgery for the first time
  • Patients who did not have a history of psychiatric problems
  • Patients who were literate
  • Patients who agreed to participate for the study

You may not qualify if:

  • Patients not over 18 years
  • Patients who hadn't undergone total knee arthroplasty surgery for the first time
  • Patients who had a history of psychiatric problems
  • Patients who weren't literate
  • Patients who didn' t agree to participate for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dıskapı Yıldırım Beyazıt Training and Research Hospital

Ankara, Altındag, 06110, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nilgün Özbaş, Assist. Prof

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants, care providers were left blind. At the same time in the statistical analysis and reporting phase, the researchers were left blind.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 4, 2021

First Posted

October 22, 2021

Study Start

June 1, 2018

Primary Completion

September 28, 2019

Study Completion

April 1, 2020

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations