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Study Summary
No. 2006-0611:.......Other Studies......Maria Suarez-Almazor......General Internal Medicine/Ambulatory Treatment & Emergency Care
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Study Summary Title
Study Summary
Number:
2006-0611
Study Title:Treatment Adherence in Patients with Rheumatic Disease
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Physician New Patient Referral
Name:Maria Suarez-AlmazorPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:General Internal Medicine/Ambulatory Treatment & Emergency CareReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-6209
Contact us about clinical trials
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General Information
Disease Group:Other StudiesSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
N/A
Treatment
Agents:
NoneHome Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
The overall objective of this study is to quantify adherence to medical recommendations in patients with rheumatoid arthritis(RA) and systemic lupus erythematosus (SLE) from diverse ethnic backgrounds, and to determine which are its predictors and outcomes, with an emphasis on psychosocial factors and medical interaction issues. We will: a) compare attitudes and behaviors toward adherence to treatment in patients with RA and SLE from diverse ethnic backgrounds; b) assess the role of patient beliefs, expectations and attitudes about their disease on their adherence to treatment; c) assess the role of selected elements of the medical interaction on patient compliance with recommendations; d) evaluate ethnic differences in compliance in the context of a modified Health Belief Model (HBM); e) determine the impact of non-compliance on patient outcomes.

Please note the subject population is entirely comprised of Non- UT MDACC patients and no patients will be seen at UT MDACC. Dr. Suarez's role in the study as a UT MDACC faculty member will be limited to data management, analysis of data and publications resulting from these analyses. Please note that no psychosocial interview, no treatment, no diagnosis and laboratory will be done on any UT MDACC patients or faculty.All patients have enrolled in the study and signed the consent forms. In Phase 2 of this study, ongoing study follow-up visits will continue at the following facilities: Michael E. DeBakey VA Hospital, LBJ Hospital, LBJ Hospital and Ben Taub Hospital. The study will follow-up with patients at 3, 6, 12, 18, and 24 month visits.All data is de-identified and coded to maintain confidentiality of patient information. All study files and tapes will be maintained in a locked file cabinet and per NIH timelines and requirements all files and tapes will be maintained for 7 years.
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Study Status Information
Study Activation / Registration Date:08/08/2006
IRB Review and Approval Date:08/01/2006
Study Type:Observational
Recruitment Status:Closed
Projected Accrual:465
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Compliancce with the American College of Rheumatology criteria for the diagnosis of RA and SLE.

2) Age - 18 to 80 years old.

3) Duration of the disease 15 years or less

4) Currently receiving treatment with steroids, DMARDS or biologic agents

5) Adequate mental status as determined by the research assistant.

6) English or Spanish Language proficiency as determined by the recruiter or interviewer

7) Self-reported ethnic background: Black non-Hispanic, Hispanic, White non-Hispanic.

Exclusion Criteria:1) Patients older than 80 years.

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Links
Registration Number: Not Applicable Clinical Trial

Other Links:
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Results


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