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

January 14, 2013 updated by: Kenneth Saag, MD, MSc, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4659

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants receiving Anti-osteoporosis Treatment
Time Frame: within 3 - 12 months of exposure to video
Includes bisphosphonates, PTH, SERM, Calcitonin
within 3 - 12 months of exposure to video

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium and Vitamin D use
Time Frame: within 3 - 12 months of exposure to video
Are participants taking calcium and vitamin d supplements
within 3 - 12 months of exposure to video
Patient-Physician Communication
Time Frame: within 3 - 12 months of exposure to video
Did viewing the video increase patient-physician communication
within 3 - 12 months of exposure to video

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Medco Health Services, Inc

Investigators

  • Principal Investigator: Kenneth G Saag, MD, MSc, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X080529001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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