A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Behavioral: Video-based Intervention

• Registration Number: NCT01907269
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of this study is to conduct a randomized trial of a tailored intervention designed to provide 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 digital video discs (DVDs). The content will be uniquely tailored to each person based on barriers to care, age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this intervention to determine differences in post-intervention rates of osteoporosis care between two randomization arms.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-24
• Study Start: 2013-08
• Primary Completion: 2015-10
• Study Completion: 2016-11
• Results First Submitted: 2018-03-09
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-29
• Last Update Submitted: 2018-05-29
• Results First Posted: 2018-06-26
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2684

Inclusion Criteria

• Self-reported history of fracture

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Exclusion Criteria

• Self-reported current prescription osteoporosis treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video-based intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Initiate an Osteoporosis Prescription Medication	6 months post-intervention	We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Use of Calcium and Vitamin D	6 and 18 months post-intervention	We will assess the use of calcium and vitamin D by participant. This will be assessed on a self-completed survey. Participants will be asked if they are currently taking a calcium supplement and/or vitamin D supplement.
Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing	6 and 18 months post-intervention	Self-report of a receipt of a DXA scan (Bone Mineral Density test).
Number of Participants That Initiate an Osteoporosis Prescription Medication	18 months	We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the outcome.

Trial Locations

Locations (7)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, 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

Group Health Research Institute; 🇺🇸 Seattle, Washington, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States