NCT07326917

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

June 1, 2025

Enrollment Period

Same day

First QC Date

December 18, 2025

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patients' knowledge regarding knee osteoarthritis questionnaire

    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)

    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.

Study Arms (1)

learning instruction package for improving Patients' Knee Osteoarthritis Outcomes

EXPERIMENTAL

participants in this group received learning instruction package

Behavioral: Learning Instruction Package

Interventions

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.

learning instruction package for improving Patients' Knee Osteoarthritis Outcomes

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing. Mansoura University, Mansoura, Dakahlia 35516

Al Mansurah, Egypt

Location

Study Officials

  • Amany Mohammed Shebl, Professor

    Mansoura University

    STUDY DIRECTOR
  • Wafaa Ismail Shereif, Professor

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A quasi- experimental research design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Medical - Surgical Nursing

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 8, 2026

Study Start

September 1, 2024

Primary Completion

September 1, 2024

Study Completion

April 30, 2025

Last Updated

January 8, 2026

Record last verified: 2025-06

Locations