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

• ClinicalTrials.gov Identifier: NCT01907269
• Recruitment Status: Completed
• First Posted: July 24, 2013
• Results First Posted: June 26, 2018
• Last Update Posted: June 26, 2018
• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); University of Massachusetts, Worcester; Helen Hayes Hospital; Kaiser Permanente; Cedars-Sinai Medical Center; University of Pittsburgh; University of Cincinnati
• Information provided by (Responsible Party): Kenneth Saag, MD, MSc, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: July 11, 2013
• First Posted Date: July 24, 2013
• Results First Submitted Date: March 9, 2018
• Results First Posted Date: June 26, 2018
• Last Update Posted Date: June 26, 2018
• Study Start Date: August 2013
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 18, 2013)

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01907269 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 29, 2018)

• 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.
• 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).
• 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.

Original Secondary Outcome Measures (submitted: July 18, 2013)

• Use of calcium and vitamin D by participant [ 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.
• Receipt of Bone mineral density (BMD) testing by participant [ Time Frame: 6 and 18 months post-intervention ]
• 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.

• Current Other Pre-specified Outcome Measures (submitted: May 29, 2018): Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care [ Time Frame: 6 and 18 months post-intervention ]
• Original Other Pre-specified Outcome Measures (submitted: July 18, 2013): Reports of communication between participant and health care provider about osteoporosis care [ Time Frame: 6 and 18 months post-intervention ]

Descriptive Information

• Brief Title: A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care
• Official Title: Activating Patients to Reduce OsteoPOrosiS

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Prevention
• Condition: Osteoporosis

Intervention

Behavioral: Video-based Intervention

Video clips delivered by DVD and Internet

Study Arms

• Experimental: 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: Behavioral: Video-based Intervention
• No Intervention: Usual care

Publications *

• 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.
• Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. Review.
• 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, Watts NB, Yood RA, Saag KG. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS): Rationale, design, and uptake of online study intervention material. Contemp Clin Trials Commun. 2016 Dec 15;4:14-24.
• 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-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial. J Bone Miner Res. 2018 May;33(5):763-772. doi: 10.1002/jbmr.3395. Epub 2018 Feb 26.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 9, 2016): 2684
• Original Estimated Enrollment (submitted: July 18, 2013): 5065
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Self-reported history of fracture

Exclusion Criteria:

• Self-reported current prescription osteoporosis treatment

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01907269
• Other Study ID Numbers: X110928001; R01AR060240 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kenneth Saag, MD, MSc, University of Alabama at Birmingham
• Study Sponsor: University of Alabama at Birmingham

Collaborators

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

Investigators

• Principal Investigator: Kenneth G Saag, MD, MSc; University of Alabama at Birmingham

• PRS Account: University of Alabama at Birmingham
• Verification Date: May 2018