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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
History of Changes
  Purpose

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 Intervention Phase
Adverse Effect of Glucocorticoids and Synthetic Analogues
Osteoporosis
Rheumatoid Arthritis
 Other: Storytelling online video
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Improving Bone Health Among RA Patients on Chronic Glucocorticoids

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 4659
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378689

Locations
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
Investigators
Principal Investigator: Kenneth G Saag, MD, MSc University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Kenneth Saag, MD, MSc, Jane Knight Lowe Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01378689     History of Changes
Other Study ID Numbers: X080529001
Study First Received: June 16, 2011
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013