A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care
NCT ID: NCT01907269
Last Updated: 2018-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2684 participants
INTERVENTIONAL
2013-08-31
2016-11-30
Brief Summary
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We hypothesize that participants randomized to the intervention arm, compared to those randomized to a control arm, will receive more osteoporosis care at 6 months post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies, (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD) testing.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Video-based intervention
Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.
Video-based Intervention
Video clips delivered by DVD and Internet
Usual care
No interventions assigned to this group
Interventions
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Video-based Intervention
Video clips delivered by DVD and Internet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
55 Years
FEMALE
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Massachusetts, Worcester
OTHER
Helen Hayes Hospital
OTHER
Kaiser Permanente
OTHER
Cedars-Sinai Medical Center
OTHER
University of Pittsburgh
OTHER
University of Cincinnati
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Kenneth Saag, MD, MSc
Professor of Medicine
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
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Massachusetts at Worcester
Worcester, Massachusetts, United States
New York University
New York, New York, United States
Jewish Hospital of Cincinnati
Cincinnati, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Group Health Research Institute
Seattle, Washington, United States
Countries
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References
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Yood RA, Mazor KM, Andrade SE, Emani S, Chan W, Kahler KH. Patient decision to initiate therapy for osteoporosis: the influence of knowledge and beliefs. J Gen Intern Med. 2008 Nov;23(11):1815-21. doi: 10.1007/s11606-008-0772-0. Epub 2008 Sep 12.
Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. doi: 10.1037//0278-6133.7.4.355.
Danila MI, Outman RC, Rahn EJ, Mudano AS, Thomas TF, Redden DT, Allison JJ, Anderson FA, Anderson JP, Cram PM, Curtis JR, Fraenkel L, Greenspan SL, LaCroix AZ, Majumdar SR, Miller MJ, Nieves JW, Safford MM, Silverman SL, Siris ES, Solomon DH, Warriner AH, Watts NB, Yood RA, Saag KG. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS): Rationale, design, and uptake of online study intervention material. Contemp Clin Trials Commun. 2016 Dec 15;4:14-24. doi: 10.1016/j.conctc.2016.06.010.
Danila MI, Outman RC, Rahn EJ, Mudano AS, Redden DT, Li P, Allison JJ, Anderson FA, Wyman A, Greenspan SL, LaCroix AZ, Nieves JW, Silverman SL, Siris ES, Watts NB, Miller MJ, Curtis JR, Warriner AH, Wright NC, Saag KG. Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial. J Bone Miner Res. 2018 May;33(5):763-772. doi: 10.1002/jbmr.3395. Epub 2018 Feb 26.
Other Identifiers
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X110928001
Identifier Type: -
Identifier Source: org_study_id
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