Improving Bone Health Among Rheumatoid Arthritis (RA) Patients on Chronic Glucocorticoids
Primary Purpose
Adverse Effect of Glucocorticoids and Synthetic Analogues, Osteoporosis, Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Storytelling online video
Sponsored by
About this trial
This is an interventional prevention trial for Adverse Effect of Glucocorticoids and Synthetic Analogues
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Online video
No video
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of participants receiving Anti-osteoporosis Treatment
Includes bisphosphonates, PTH, SERM, Calcitonin
Secondary Outcome Measures
Calcium and Vitamin D use
Are participants taking calcium and vitamin d supplements
Patient-Physician Communication
Did viewing the video increase patient-physician communication
Full Information
NCT ID
NCT01378689
First Posted
June 16, 2011
Last Updated
January 14, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
Medco Health Services, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01378689
Brief Title
Improving Bone Health Among Rheumatoid Arthritis (RA) Patients on Chronic Glucocorticoids
Official Title
Improving Bone Health Among RA Patients on Chronic Glucocorticoids
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Medco Health Services, Inc
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect of Glucocorticoids and Synthetic Analogues, Osteoporosis, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
4659 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online video
Arm Type
Experimental
Arm Description
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.
Arm Title
No video
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Storytelling online video
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants receiving Anti-osteoporosis Treatment
Description
Includes bisphosphonates, PTH, SERM, Calcitonin
Time Frame
within 3 - 12 months of exposure to video
Secondary Outcome Measure Information:
Title
Calcium and Vitamin D use
Description
Are participants taking calcium and vitamin d supplements
Time Frame
within 3 - 12 months of exposure to video
Title
Patient-Physician Communication
Description
Did viewing the video increase patient-physician communication
Time Frame
within 3 - 12 months of exposure to video
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth G Saag, MD, MSc
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26136484
Citation
Warriner AH, Outman RC, Allison JJ, Curtis JR, Markward NJ, Redden DT, Safford MM, Stanek EJ, Steinkellner AR, Saag KG. An Internet-based Controlled Trial Aimed to Improve Osteoporosis Prevention among Chronic Glucocorticoid Users. J Rheumatol. 2015 Aug;42(8):1478-83. doi: 10.3899/jrheum.141238. Epub 2015 Jul 1.
Results Reference
derived
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Improving Bone Health Among Rheumatoid Arthritis (RA) Patients on Chronic Glucocorticoids
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