Improving Bone Health Among Rheumatoid Arthritis (RA) Patients on Chronic Glucocorticoids

Rheumatoid Arthritis Clinical Trial

Official title:

Improving Bone Health Among RA Patients on Chronic Glucocorticoids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378689
• Other study ID #: X080529001
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2011
• Last updated: January 14, 2013
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This quality improvement project is aimed at improving health care by identifying low cost strategies to get Rheumatoid Arthritis (RA) patients to more effectively communicate with their physicians about osteoporosis prevention and treatment (improving doctor-patient communication). The investigators will implement a direct to patient intervention to the population of interest (patients on chronic glucocorticoids) via story-telling, using an Internet based video. The target audience is people on chronic glucocorticoids not already receiving bones-specific osteoporosis medications to determine differences in post-intervention rates of osteoporosis care, and the rates of prescription anti-osteoporosis therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4659
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Greater than or equal to 5 milligrams of prednisone or glucocorticoid dose equivalent for greater than or equal to 90 days within the previous 12 months

• Medco member for entire study period

• Refill steroid prescription online

Exclusion Criteria:

• anti-osteoporosis medication in previous 12 months

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adverse Effect of Glucocorticoids and Synthetic Analogues
• Arthritis
• Arthritis, Rheumatoid
• Osteoporosis
• Rheumatoid Arthritis

Intervention

Other:
• Storytelling online video
patients with a history of chronic glucocorticoids use tell their experiences of side effects resulting from chronic use and provide advice on ways to prevent side effects

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Medco Health Services, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants receiving Anti-osteoporosis Treatment	Includes bisphosphonates, PTH, SERM, Calcitonin	within 3 - 12 months of exposure to video	No
Secondary	Calcium and Vitamin D use	Are participants taking calcium and vitamin d supplements	within 3 - 12 months of exposure to video	No
Secondary	Patient-Physician Communication	Did viewing the video increase patient-physician communication	within 3 - 12 months of exposure to video	No