NCT01378689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,659

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

June 16, 2011

Last Update Submit

January 14, 2013

Conditions

Adverse Effect of Glucocorticoids and Synthetic AnaloguesOsteoporosisRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of participants receiving Anti-osteoporosis Treatment

    Includes bisphosphonates, PTH, SERM, Calcitonin

    within 3 - 12 months of exposure to video

Secondary Outcomes (2)

  • Calcium and Vitamin D use

    within 3 - 12 months of exposure to video

  • Patient-Physician Communication

    within 3 - 12 months of exposure to video

Study Arms (2)

Online video

EXPERIMENTAL

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

No video

NO INTERVENTION

Interventions

Storytelling online videoOTHER

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

Online video

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • anti-osteoporosis medication in previous 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 26136484DERIVED

MeSH Terms

Conditions

OsteoporosisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kenneth G Saag, MD, MSc

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jane Knight Lowe Professor of Medicine

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 22, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)