NCT03316027

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 30, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
2 years until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

September 30, 2017

Last Update Submit

July 2, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients adherent to the treatment through MMAS-8.

    The use of Morisky Medication Adherence Scale 8- item (MMAS-8) to determining percentage of patients adherent to treatment.

    6 months.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients from both sex, aged more than or equal 18 years old, attending Physical Medicine, Rheumatology and Rehabilitation department, Assiut University Hospital, on current diagnosis of RA from at least 6 months and current treatment with one or more of DMARDS, with cognitive level enabling them to interact in the study, and free from psychiatric diagnosis other than effective disorder, associated disability due to neurological disorder or trauma and also free from major internal organ failure.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 18336875BACKGROUND

  • 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.

    PMID: 20881757BACKGROUND

  • 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.

    PMID: 18490431BACKGROUND

  • 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.

    PMID: 12508408BACKGROUND

  • 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.

    PMID: 6880820BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Esraa Moustafa Mohammed, Master student

CONTACT

01094335622moustafaesraa0@gmail.com

Tayser Mohamed Khedr, Professor

CONTACT

01006061809dr.tayseeer@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 30, 2017

First Posted

October 20, 2017

Study Start

November 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07