Activating Patients to Reduce OsteoPOrosiS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,684
- Locations
- 7
- Primary Endpoint
- Number of Participants That Initiate an Osteoporosis Prescription Medication
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Self-reported history of fracture
Exclusion Criteria
- •Self-reported current prescription osteoporosis treatment
Arms & Interventions
Usual care
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.
Intervention: Video-based Intervention (Behavioral)
Outcomes
Primary Outcomes
Number of Participants That Initiate an Osteoporosis Prescription Medication
Time Frame: 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 Outcomes
- Number of Participants Who Reported Use of Calcium and Vitamin D(6 and 18 months post-intervention)
- Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing(6 and 18 months post-intervention)
- Number of Participants That Initiate an Osteoporosis Prescription Medication(18 months)
Investigators
Kenneth Saag, MD, MSc
Professor of Medicine
University of Alabama at Birmingham