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

NCT ID: NCT01378689

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

4659 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adverse Effect of Glucocorticoids and Synthetic Analogues Osteoporosis Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Storytelling online video

Intervention Type OTHER

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 video

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medco Health Services, Inc

UNKNOWN

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Saag, MD, MSc

Jane Knight Lowe Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth G Saag, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26136484 (View on PubMed)

Other Identifiers

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X080529001

Identifier Type: -

Identifier Source: org_study_id

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