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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01378689
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : January 16, 2013
Medco Health Services, Inc
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Adverse Effect of Glucocorticoids and Synthetic Analogues Osteoporosis Rheumatoid Arthritis Other: Storytelling online video Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4659 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Improving Bone Health Among RA Patients on Chronic Glucocorticoids
Study Start Date : September 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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

No Intervention: No video

Primary Outcome Measures :
  1. Number of participants receiving Anti-osteoporosis Treatment [ Time Frame: within 3 - 12 months of exposure to video ]
    Includes bisphosphonates, PTH, SERM, Calcitonin

Secondary Outcome Measures :
  1. Calcium and Vitamin D use [ Time Frame: within 3 - 12 months of exposure to video ]
    Are participants taking calcium and vitamin d supplements

  2. Patient-Physician Communication [ Time Frame: within 3 - 12 months of exposure to video ]
    Did viewing the video increase patient-physician communication

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01378689

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Medco Health Services, Inc
Principal Investigator: Kenneth G Saag, MD, MSc University of Alabama at Birmingham

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kenneth Saag, MD, MSc, Jane Knight Lowe Professor of Medicine, University of Alabama at Birmingham Identifier: NCT01378689     History of Changes
Other Study ID Numbers: X080529001
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs