Adherence Rate to DMARDS in Egyptian Patients With RA

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03316027
• Lead Sponsor: Assiut University

Brief Summary

The study aims at determining adherence rate to DMARDS and predicting factors affecting treatment adherence among sample of Egyptian patients with RA.

Detailed Description

Rheumatoid arthritis (RA) is an autoimmune disease that causes inflammation of the joints. It is chronic disease and often progressive in course and has a strong impact on people's everyday lives.

Disease Modifying Anti-Rheumatic Drugs (DMARDS), such as methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine are the cornerstone of therapy in RA and are invariably used as initial therapy.

These drugs have shown to retard disease progression including joint destruction.

It is believed that adherence to treatment is crucial for successful therapy, however, non-adherence is a substantial problem in patients with chronic rheumatic conditions, including RA.

Previous studies have reported that DMARDS non adherence results in more disease activity, loss of function, and a lower quality of life.

The depression is a common co-morbidity in RA, its presence can alter the course of RA negatively via cognitive-behavioral or inflammatory pathways: patients with concurrent depression suffer from more pain, show a heightened disease activity.

As non-adherence to medication regimen is considered a serious public health issue that can have great impact on clinical and economic consequences. therefore, it is crucial for health care providers to assess the patient condition, predict the possible causes of non-adherence, and put a policy for increasing medication adherence and achieving the best health outcome.

Also, improving medication adherence enhances patients' safety and health condition.

Study Timeline

• Study First Submitted: 2017-09-30
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05
• Study Start: 2019-11
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

1. Age more than or equal 18 years old.
2. On current diagnosis of RA determined by a Rheumatologist according to 2010 ACR/EULAR classification criteria for RA.
3. On current treatment with one or more of DMARDS from at least 6 months duration.
4. Patients with cognitive level enabling them to interact in the study. -

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Exclusion Criteria

1. Age less than 18 years old.
2. Patients receiving one or more of DMARDS of period less than 6 months.
3. Patients with psychiatric diagnosis other than effective disorder.
4. Patients with associated disability due to neurological disorder or trauma.
5. Patients with major internal organ failure e.g. heart failure, end stage renal disease or hepatic failure.
6. Patients with severe cognitive impairment interfering with the proper communication and interaction within the study process.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients adherent to the treatment through MMAS-8.	6 months.	The use of Morisky Medication Adherence Scale 8- item (MMAS-8) to determining percentage of patients adherent to treatment.