Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis (OA)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
health education
Sponsored by
About this trial
This is an interventional other trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Adherence, Patient education, Guidelines
Eligibility Criteria
Inclusion Criteria: diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria Exclusion Criteria: Patients with a A history of knee trauma or injury patients suffering from any other rheumatological diseases (e.g., Rheumatoid Arthritis) severe comorbidities, severe cardiovascular disease, heart failure, gastrointestinal bleeding risk, and chronic kidney disease.
Sites / Locations
- Zagazig University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
intervention group
control group
Arm Description
Outcomes
Primary Outcome Measures
improved patient pain
measured by visual analog scale
improved patients function
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06064253
First Posted
September 24, 2023
Last Updated
September 28, 2023
Sponsor
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT06064253
Brief Title
Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis
Acronym
OA
Official Title
Impact Of Health Education Program on Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
May 24, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee, Adherence, Patient education, Guidelines
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Other
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
health education
Other Intervention Name(s)
exercise and diet plan
Intervention Description
adherence to treatment
Primary Outcome Measure Information:
Title
improved patient pain
Description
measured by visual analog scale
Time Frame
3 months
Title
improved patients function
Description
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
Time Frame
3 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria
Exclusion Criteria:
Patients with a
A history of knee trauma or injury
patients suffering from any other rheumatological diseases (e.g., Rheumatoid Arthritis)
severe comorbidities, severe cardiovascular disease, heart failure, gastrointestinal bleeding risk, and chronic kidney disease.
Facility Information:
Facility Name
Zagazig University Hospitals
City
Zagazig
State/Province
El Sharkia
ZIP/Postal Code
44511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis
We'll reach out to this number within 24 hrs