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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteoporosis Behavioral: Video-based Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Activating Patients to Reduce OsteoPOrosiS
Study Start Date : August 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: Video-based Intervention
Video clips delivered by DVD and Internet
No Intervention: Usual care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care [ Time Frame: 6 and 18 months post-intervention ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-reported history of fracture

Exclusion Criteria:

  • Self-reported current prescription osteoporosis treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907269


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
University of Massachusetts at Worcester
Worcester, Massachusetts, United States, 01655
United States, New York
New York University
New York, New York, United States, 10016
United States, Ohio
Jewish Hospital of Cincinnati
Cincinnati, Ohio, United States, 45236
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of Alabama at Birmingham
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
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Principal Investigator: Kenneth G Saag, MD, MSc University of Alabama at Birmingham
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Kenneth Saag, MD, MSc, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01907269    
Other Study ID Numbers: X110928001
R01AR060240 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2013    Key Record Dates
Results First Posted: June 26, 2018
Last Update Posted: June 26, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases