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Patient Activation After DXA Result Notification (PAADRN)

This study has been completed.
Sponsor:
Collaborators:
University of Alabama at Birmingham
Kaiser Permanente
University of Toronto
University of Pittsburgh
Information provided by (Responsible Party):
Fredric D Wolinsky, University of Iowa
ClinicalTrials.gov Identifier:
NCT01507662
First received: December 8, 2011
Last updated: February 24, 2017
Last verified: February 2017
Results First Received: February 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Health Services Research
Conditions: Osteoporosis
Bone Diseases, Metabolic
Intervention: Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients presenting for DXA centers were recruited through February 2012 to August 2014 at three health centers—the University of Iowa (UI), the University of Alabama at Birmingham (UAB), and Kaiser Permanente of Georgia (KPGA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BMD Result Letter and Brochure

Patients who receive the intervention - BMD result letter with brochure

Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Control Usual care

Participant Flow:   Overall Study
    BMD Result Letter and Brochure   Control
STARTED   3898   3851 
COMPLETED   3082   3020 
NOT COMPLETED   816   831 
Death                26                18 
Withdrawal by Subject                290                287 
Lost to Follow-up                498                523 
Proxy interview done                2                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BMD Result Letter and Brochure

Patients who receive the intervention - BMD result letter with brochure

Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Control Usual care
Total Total of all reporting groups

Baseline Measures
   BMD Result Letter and Brochure   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 3898   3851   7749 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.5  (8.4)   66.7  (8.2)   66.6  (8.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3259  83.6%      3230  83.9%      6489  83.7% 
Male      639  16.4%      621  16.1%      1260  16.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      74   1.9%      77   2.0%      151   1.9% 
Not Hispanic or Latino      3824  98.1%      3774  98.0%      7598  98.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      4   0.1%      3   0.1%      7   0.1% 
Asian      37   0.9%      43   1.1%      80   1.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   0.0%      1   0.0% 
Black or African American      842  21.6%      814  21.1%      1656  21.4% 
White      2981  76.5%      2954  76.7%      5935  76.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      34   0.9%      36   0.9%      70   0.9% 
Region of Enrollment 
[Units: Participants]
     
United States   3898   3851   7749 


  Outcome Measures

1.  Primary:   Guideline Concordant Osteoporosis Therapy   [ Time Frame: 12 weeks after DXA ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Fredric Wolinsky
Organization: University of Iowa
phone: (319) 384-3821
e-mail: fredric-wolinsky@uiowa.edu


Publications of Results:
Other Publications:

Responsible Party: Fredric D Wolinsky, University of Iowa
ClinicalTrials.gov Identifier: NCT01507662     History of Changes
Other Study ID Numbers: 201107758
Study First Received: December 8, 2011
Results First Received: February 24, 2017
Last Updated: February 24, 2017