Adherence Rate to DMARDS in Egyptian Patients With RA

NCT ID: NCT03316027

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-30

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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. -

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Moustafa Mohammed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Esraa Moustafa Mohammed, Master student

Role: CONTACT

01094335622

Tayser Mohamed Khedr, Professor

Role: CONTACT

01006061809

References

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Harrold LR, Andrade SE. Medication adherence of patients with selected rheumatic conditions: a systematic review of the literature. Semin Arthritis Rheum. 2009 Apr;38(5):396-402. doi: 10.1016/j.semarthrit.2008.01.011. Epub 2008 Mar 12.

Reference Type BACKGROUND
PMID: 18336875 (View on PubMed)

Contreras-Yanez I, Ponce De Leon S, Cabiedes J, Rull-Gabayet M, Pascual-Ramos V. Inadequate therapy behavior is associated to disease flares in patients with rheumatoid arthritis who have achieved remission with disease-modifying antirheumatic drugs. Am J Med Sci. 2010 Oct;340(4):282-90. doi: 10.1097/MAJ.0b013e3181e8bcb0.

Reference Type BACKGROUND
PMID: 20881757 (View on PubMed)

Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.

Reference Type BACKGROUND
PMID: 18490431 (View on PubMed)

Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol. 2003 Jan;30(1):167-78.

Reference Type BACKGROUND
PMID: 12508408 (View on PubMed)

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

Reference Type BACKGROUND
PMID: 6880820 (View on PubMed)

Other Identifiers

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DMARDS in RA

Identifier Type: -

Identifier Source: org_study_id

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