A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care (APROPOS)

The University of Alabama at Birmingham

Status: Completed

Conditions: Osteoporosis

Treatments: Behavioral: Video-based Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01907269

R01AR060240 (U.S. NIH Grant/Contract)

X110928001

Details and patient eligibility

About

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.

Enrollment: 2,684 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Self-reported history of fracture

Exclusion criteria

• Self-reported current prescription osteoporosis treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,684 participants in 2 patient groups

Video-based intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Video-based Intervention

Usual care

No Intervention group