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

Osteoporosis Clinical Trial

— APROPOS  

Official title:

Activating Patients to Reduce OsteoPOrosiS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907269
• Other study ID #: X110928001
• Secondary ID: R01AR060240
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: November 2016

Study information

• Verified date: May 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2684
• Est. completion date: November 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Self-reported history of fracture

Exclusion Criteria:

• Self-reported current prescription osteoporosis treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Video-based Intervention
Video clips delivered by DVD and Internet

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Jewish Hospital of Cincinnati	Cincinnati	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	New York University	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Group Health Research Institute	Seattle	Washington
United States	University of Massachusetts at Worcester	Worcester	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	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

Country where clinical trial is conducted

United States, 

References & Publications (4)

Danila MI, Outman RC, Rahn EJ, Mudano AS, Redden DT, Li P, Allison JJ, Anderson FA, Wyman A, Greenspan SL, LaCroix AZ, Nieves JW, Silverman SL, Siris ES, Watts NB, Miller MJ, Curtis JR, Warriner AH, Wright NC, Saag KG. Evaluation of a Multimodal, Direct-t — View Citation

Danila MI, Outman RC, Rahn EJ, Mudano AS, Thomas TF, Redden DT, Allison JJ, Anderson FA, Anderson JP, Cram PM, Curtis JR, Fraenkel L, Greenspan SL, LaCroix AZ, Majumdar SR, Miller MJ, Nieves JW, Safford MM, Silverman SL, Siris ES, Solomon DH, Warriner AH, — View Citation

Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. Review. — View Citation

Yood RA, Mazor KM, Andrade SE, Emani S, Chan W, Kahler KH. Patient decision to initiate therapy for osteoporosis: the influence of knowledge and beliefs. J Gen Intern Med. 2008 Nov;23(11):1815-21. doi: 10.1007/s11606-008-0772-0. Epub 2008 Sep 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care		6 and 18 months post-intervention
Primary	Number of Participants That Initiate an Osteoporosis Prescription Medication	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.	6 months post-intervention
Secondary	Number of Participants Who Reported Use of Calcium and Vitamin D	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.	6 and 18 months post-intervention
Secondary	Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing	Self-report of a receipt of a DXA scan (Bone Mineral Density test).	6 and 18 months post-intervention
Secondary	Number of Participants That Initiate an Osteoporosis Prescription Medication	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.	18 months