NCT06064253

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable knee-osteoarthritis

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

January 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

September 24, 2023

Last Update Submit

January 22, 2024

Conditions

Keywords

OsteoarthritisKneeAdherencePatient educationGuidelines

Outcome Measures

Primary Outcomes (2)

  • measuring KOA patients adherence

    adherence survey based on morsiky adherence scale

    3 months

  • improved patients function and improved patient pain

    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 --measured by visual analog scale

    3 MONTHS

Secondary Outcomes (1)

  • investigating the factors that hinder patient adherence

    3 months

Study Arms (2)

intervention group

OTHER

health education program explaining the nature of the condition(KOA causes, pathological changes, and natural course of the disease), we explained the recommendations for the treatment of KOA, teaching the patient a home exercise program of 5 exercises (targeting knee extensor and hip muscle ), selection of a physiotherapy program suitable to the patient clinical condition, recommendations to increase daily physical activity ( e.g. brisk walking) with joint protection measures along with a weight reduction regimen proposed in overweight and obese patients and prescribing a suitable pharmacological treatment to the patients

Behavioral: health education

control group

NO INTERVENTION

were assigned the traditional approach for KOA management, they were told their diagnosis if they were not already familiar with it, received the treatment for KOA according to ACR guidelines, they were offered physical therapy modalities if their condition required but they were not given the health education program or the other interventional steps.

Interventions

adherence to treatment

Also known as: exercise and diet plan
intervention group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44511, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 24, 2023

First Posted

October 3, 2023

Study Start

January 12, 2023

Primary Completion

May 24, 2023

Study Completion

September 1, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations