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

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.

Conditions

• Osteoporosis

Interventions

BEHAVIORAL

Video-based Intervention

Video clips delivered by DVD and Internet

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• University of Massachusetts, Worcester

  collaborator OTHER

• Helen Hayes Hospital

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Kenneth G Saag, MD, MSc · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2015-10-31

Completion

2016-11-30

Countries

• United States

Study Locations