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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT01378689
Collaborator
Medco Health Services, Inc (Other)
4,659
Enrollment
1
Location
2
Arms
27
Duration (Months)
172.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Storytelling online video
 Phase 4

Study Design

Study Type:
Interventional
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 :
Sep 1, 2010
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants receiving Anti-osteoporosis Treatment [within 3 - 12 months of exposure to video]

    Includes bisphosphonates, PTH, SERM, Calcitonin

Secondary Outcome Measures

  1. Calcium and Vitamin D use [within 3 - 12 months of exposure to video]

    Are participants taking calcium and vitamin d supplements

  2. Patient-Physician Communication [within 3 - 12 months of exposure to video]

    Did viewing the video increase patient-physician communication

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kenneth Saag, MD, MSc, Jane Knight Lowe Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01378689
Other Study ID Numbers:
  • X080529001
First Posted:
Jun 22, 2011
Last Update Posted:
Jan 16, 2013
Last Verified:
Jan 1, 2013
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoporosis

Study Results

No Results Posted as of Jan 16, 2013