Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis (OA)

January 22, 2024 updated by: Amany Mohammed Ibrahim Ebaid, Zagazig University

Impact Of Health Education Program on Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

2.3. interventional protocol (for intervention group only): For the Intervention group: A face-to-face semi-structured interview was carried out with each participant separately. The interview (30-45minuts) included a 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 mentioning side effect that might occur. At the end of the interview, each participant received a booklet including the recommendations for the treatment of knee osteoarthritis according to the ACR.

As for the control group, they 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.

2.4. Follow-up period: Throughout the following three months after enrollment, participants were followed up every ten days; asking about persistence on the prescribed treatment and exercise program, the level of their daily activity, and their diet plan. For participants who failed to attend for any reason, a telephone call was performed to provide behavior change support in both groups. The telephone call aimed to observe adherence to treatment in the control group and to increase levels of participation in the intervention group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Sharkia
      • Zagazig, El Sharkia, Egypt, 44511
        • Zagazig University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: intervention group
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
adherence to treatment
Other Names:
  • exercise and diet plan
No Intervention: control group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measuring KOA patients adherence
Time Frame: 3 months
adherence survey based on morsiky adherence scale
3 months
improved patients function and improved patient pain
Time Frame: 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

--measured by visual analog scale
3 MONTHS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
investigating the factors that hinder patient adherence
Time Frame: 3 months
WHO frame work foe adherence
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB #:4677

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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