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

This study has been completed.
Sponsor:
Collaborator:
Medco Health Services, Inc
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01378689
First received: June 16, 2011
Last updated: January 14, 2013
Last verified: January 2013

June 16, 2011
January 14, 2013
September 2010
March 2012   (final data collection date for primary outcome measure)
Number of participants receiving Anti-osteoporosis Treatment [ Time Frame: within 3 - 12 months of exposure to video ] [ Designated as safety issue: No ]
Includes bisphosphonates, PTH, SERM, Calcitonin
Same as current
Complete list of historical versions of study NCT01378689 on ClinicalTrials.gov Archive Site
  • Calcium and Vitamin D use [ Time Frame: within 3 - 12 months of exposure to video ] [ Designated as safety issue: No ]
    Are participants taking calcium and vitamin d supplements
  • Patient-Physician Communication [ Time Frame: within 3 - 12 months of exposure to video ] [ Designated as safety issue: No ]
    Did viewing the video increase patient-physician communication
Same as current
Not Provided
Not Provided
 
Improving Bone Health Among Rheumatoid Arthritis (RA) Patients on Chronic Glucocorticoids
Improving Bone Health Among RA Patients on Chronic Glucocorticoids

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Adverse Effect of Glucocorticoids and Synthetic Analogues
  • Osteoporosis
  • Rheumatoid Arthritis
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
  • Experimental: Online video
    Participants in this arm are shown a brief video (~5 minutes) after ordering a refill for their glucocorticoid use. The video includes real patients telling their own story about the possible side effects of prolonged use of glucocorticoids.
    Intervention: Other: Storytelling online video
  • No Intervention: No video
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4659
December 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01378689
X080529001
No
Kenneth Saag, MD, MSc, University of Alabama at Birmingham
University of Alabama at Birmingham
Medco Health Services, Inc
Principal Investigator: Kenneth G Saag, MD, MSc University of Alabama at Birmingham
University of Alabama at Birmingham
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP