Effect of Learning Instruction Package on Patients' Knee Osteoarthritis Outcomes

The aim of this study is to evaluate the effect of learning instruction package on patients' knee osteoarthritis outcomes.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Behavioral: Learning Instruction Package

Detailed Description

Musculoskeletal disorders are a group of diseases of the body's motor structures, particularly the bones, joints, muscles, fascia, and other supporting structures such as ligaments and cartilages. In fact, it is estimated that approximately 1.71 billion people are living with a musculoskeletal condition.

Osteoarthritis (OA) is the most common chronic joint disorder, characterized by local inflammation and joint structural change, it is associated with painful symptoms and loss of function leading to considerable impairment of quality of life. The rising rates of disability caused by osteoarthritis highlight the need for implementing preventative measures at early stages of the disease, which would especially benefit subjects at high risk for osteoarthritis development. Several joints are mainly affected by osteoarthritis, especially the knee, hip, hands, feet, shoulders, and spine.

Knee osteoarthritis (KOA) is a common chronic articular disease worldwide. It is also the most common form of osteoarthritis (OA) that affects the entire knee joint and is characterized by high morbidity and disability rates. It is ranked as the 10th largest contributor to global years lived with disabilities, and its prevalence has more than doubled in the last 10 years.

The main clinical symptoms of KOA are limb mobility difficulties, pain and swelling around the joint, which is more obvious after morning, and can lead to paralysis in the later stage. Pain is the key symptom of KOA and the main driver for functional disability and negative impact on different aspects of quality of life (QoL), including mobility, participation, mood and sleep. Patients may experience a serious impact on daily activities due to difficulty in walking, moving, climbing stairs, and while sitting on a chair with weakness of the thigh muscles.

Early diagnosis and treatment of knee osteoarthritis is more beneficial and easily managed compared to when it has worsened. The treatment includes nonpharmacological, pharmacological, and surgical modalities. Learning instruction has been recognized as one of the fundamental components for successful management of knee osteoarthritis, that involve teaching of patients regarding regular exercise, weight management, eating a balanced healthy diet, and applying of local cold or warm compress to improve patient knowledge, developing self-management and life skills.

Nurse plays a vital role in teaching and learning process, and providing valuable information for patients with knee osteoarthritis to improve health outcomes through modifying risk factors for disease progression, preventing further loss of function of the affected joints, relieving pain, improving joint function, optimizing daily living activities, and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • Faculty of Nursing. Mansoura University, Mansoura, Dakahlia 35516

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female patients.
• Age between 20 and 60 years.
• Clinically diagnosed with knee osteoarthritis.
• Able to communicate and follow instructions.

Exclusion Criteria:

• History of any orthopaedic surgical procedure on the affected knee.
• Presence of any physical disability that may interfere with participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: learning instruction package for improving Patients' Knee Osteoarthritis Outcomes; participants in this group received learning instruction package

Behavioral: Learning Instruction Package; participants received learning instruction package covered knowledge about knee osteoarthritis; definition, causes, risk factors, pathophysiology, signs, symptoms, and complications, and discussion how to improve knee osteoarthritis outcomes through weight management, diet management, regular exercise, application of compress, and how to apply it properly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' Knee Osteoarthritis Outcomes	Assessment of patients' Knee Osteoarthritis Outcomes by using The Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. The KOOS's five patient-relevant dimensions were scored separately: Pain (nine items), Symptoms (seven items), ADL Function (seventeen items), Sport and Recreation Function (five items), and Quality of Life (four items).	Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' knowledge regarding knee osteoarthritis questionnaire	Assessment of patients' knowledge about knee osteoarthritis pre & post learning instruction package. It included knowledge regarding disease and its management, that consisted of sixteen multiple-choice, closed-ended questions.	Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.
Body Mass Index (BMI)	BMI= Weight (kg) / Height (m2). It was categorized as follows: below 18.5 is underweight, 18.5- 24.9 is normal or healthy weight, 25- 29.9 is overweight, and 30 and above is obese.	Basline, The first evaluation was conducted one month after completion of implementation of the learning instruction package, serving as a post-test, and the second evaluation was conducted one month after the first evaluation, as a follow-up.

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Wafaa Ismail Shereif, Professor, Mansoura University; Study Director: Amany Mohammed Shebl, Professor, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Instruction Package on Patient

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No