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Trial record 80 of 235 for:    CALCITONIN SALMON

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

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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

Tracking Information
First Submitted Date  ICMJE July 11, 2013
First Posted Date  ICMJE July 24, 2013
Results First Submitted Date  ICMJE March 9, 2018
Results First Posted Date  ICMJE June 26, 2018
Last Update Posted Date June 26, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT01907269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Osteoporosis
Intervention  ICMJE Behavioral: Video-based Intervention
Video clips delivered by DVD and Internet
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2016)
2684
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2013)
5065
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Self-reported history of fracture

Exclusion Criteria:

  • Self-reported current prescription osteoporosis treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01907269
Other Study ID Numbers  ICMJE X110928001
R01AR060240 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Saag, MD, MSc, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Kenneth G Saag, MD, MSc University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP