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Completed

NCT Number: NCT01907269

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-reported history of fracture

Exclusion criteria

  • Self-reported current prescription osteoporosis treatment

Treatment and study plan

Video-Based Intervention

Behavioral

Video clips delivered by DVD and Internet

Primary outcomes

  1. 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

  1. Number of Participants Who Reported Use of Calcium and Vitamin D

    Time frame: 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.

  2. Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing

    Time frame: 6 and 18 months post-intervention

    Self-report of a receipt of a DXA scan (Bone Mineral Density test).

  3. Number of Participants That Initiate an Osteoporosis Prescription Medication

    Time frame: 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.

Other outcomes

  1. Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care

    Time frame: 6 and 18 months post-intervention

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Cedars-Sinai Medical Center
  • Helen Hayes Hospital
  • Kaiser Permanente
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • University of Cincinnati
  • University of Massachusetts, Worcester
  • University of Pittsburgh

Registry information

Official study title

Activating Patients to Reduce OsteoPOrosiS

Acronym: APROPOS

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 24, 2013
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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