OA: Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis

• Sponsor: Zagazig University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06064253
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 20.2

Study Details

Study Description

Brief Summary

the aim is to measure the level of adherence of knee osteoartheritis patients to a Carefully curated program that follows the American College of Rheumatology/Arthritis (ACR) recommendation guidelines and investigate the factor that might affect the patient's adherence to the prescribed protocol.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Behavioral: health education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Impact Of Health Education Program on Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis
• Actual Study Start Date: Jan 12, 2023
• Actual Primary Completion Date: May 24, 2023
• Actual Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: intervention group	Behavioral: health education; adherence to treatment; Other Names: exercise and diet plan
No Intervention: control group

Outcome Measures

Primary Outcome Measures

1. improved patient pain [3 months]

   measured by visual analog scale

2. improved patients function [3 MONTHS]

   measured by Western Ontario and McMaster University Osteoarthritis Index contains 5 items that address the following person-level activities: walking, stair climbing, sitting, lying down, and standing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria

Exclusion Criteria:

• Patients with a

1. A history of knee trauma or injury

2. patients suffering from any other rheumatological diseases (e.g., Rheumatoid Arthritis)

3. severe comorbidities, severe cardiovascular disease, heart failure, gastrointestinal bleeding risk, and chronic kidney disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zagazig University Hospitals	Zagazig	El Sharkia	Egypt	44511

Sponsors and Collaborators

• Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amany Mohammed Ibrahim Ebaid, Associate professor, Zagazig University
• ClinicalTrials.gov Identifier: NCT06064253
• Other Study ID Numbers: IRB #:4677
• First Posted: Oct 3, 2023
• Last Update Posted: Oct 3, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amany Mohammed Ibrahim Ebaid, Associate professor, Zagazig University: Osteoarthritis; Knee; Adherence; Patient education; Guidelines
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Oct 3, 2023