Knee OsteoarthritisOANCT06064253
Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis
A study testing health education in people with Knee Osteoarthritis, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- health education
- Keywords
- Osteoarthritis, Knee, Adherence, Patient education, Guidelines
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationBehavioural
Also called exercise and diet plan
adherence to treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring KOA patients adherence
adherence survey based on morsiky adherence scale
Measured: 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
Measured: 3 MONTHS
Secondary outcomes (1)
investigating the factors that hinder patient adherence
WHO frame work foe adherence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start12 Jan 2023
- Primary completion24 May 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amany Mohammed Ibrahim Ebaid, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064253
- Sponsor's protocol ID
- IRB #:4677
- Acronym
- OA
- Status last verified
- Jan 2024
- First submitted
- 24 Sep 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ebaid AM, Mortada MA, Abd-Ghani FA, Ali SA. Impact of Health Education Programme on Adherence to Treatment in Knee Osteoarthritis: An Interventional Study on Egyptian Patients. Musculoskeletal Care. 2024 Dec;22(4):e1954. doi: 10.1002/msc.1954.
PubMed 39404638
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Health Education Program on Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06064253
- Acronym / sponsor ID
- OA / IRB #:4677
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Adherence, Patient education, Guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Other | Behavioral: health educationhealth 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria
Key exclusion criteria (4 listed)
- Patients with a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health educationAlso: exercise and diet planadherence to treatment | Behavioural | intervention group |
Primary outcome
measuring KOA patients adherence
Time frame: 3 months
adherence survey based on morsiky adherence scale
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
1 secondary outcome
investigating the factors that hinder patient adherence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 39404638Ebaid AM, Mortada MA, Abd-Ghani FA, Ali SA. Impact of Health Education Programme on Adherence to Treatment in Knee Osteoarthritis: An Interventional Study on Egyptian Patients. Musculoskeletal Care. 2024 Dec;22(4):e1954. doi: 10.1002/msc.1954.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education in people with Knee Osteoarthritis, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring KOA patients adherence (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.