Osteoporosis Clinical Trial
— PAADRNOfficial title:
Patient Activation After DXA Result Notification
NCT number | NCT01507662 |
Other study ID # | 201107758 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2012 |
Est. completion date | November 2015 |
Verified date | November 2020 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There is growing evidence that patients undergoing bone mineral density testing (BMD) often do not take important steps to improve their bone health. The investigators will conduct a randomized-controlled trial to evaluate the impact of a novel and practical patient activation intervention (mailing patients their bone density test results) on the quality of bone-related healthcare and the cost-effectiveness of BMD testing. Equally important, the investigators intervention could easily be modified to include other patient populations and chronic diseases.
Status | Completed |
Enrollment | 7749 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: 1. patients presenting for DXA 2. age 50 years of age or older Exclusion Criteria: 1. non-English speakers 2. prisoners 3. people who have mental disabilities 4. individuals younger than age 50 years 5. individuals who do not have access to a telephone 6. deaf patients |
Country | Name | City | State |
---|---|---|---|
Canada | University of Toronto | Toronto | Ontario |
United States | Kaiser Permanente Georgia | Atlanta | Georgia |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Fredric D Wolinsky | Kaiser Permanente, University of Alabama at Birmingham, University of Pittsburgh, University of Toronto |
United States, Canada,
Cram P, Wolinsky FD, Lou Y, Edmonds SW, Hall SF, Roblin DW, Wright NC, Jones MP, Saag KG; PAADRN Investigators. Patient-activation and guideline-concordant pharmacological treatment after bone density testing: the PAADRN randomized controlled trial. Osteo — View Citation
Edmonds SW, Cram P, Lou Y, Jones MP, Roblin DW, Saag KG, Wright NC, Wolinsky FD; PAADRN Investigators. Effects of a DXA result letter on satisfaction, quality of life, and osteoporosis knowledge: a randomized controlled trial. BMC Musculoskelet Disord. 20 — View Citation
Edmonds SW, Cram P, Lu X, Roblin DW, Wright NC, Saag KG, Solimeo SL; PAADRN Investigators. Improving bone mineral density reporting to patients with an illustration of personal fracture risk. BMC Med Inform Decis Mak. 2014 Nov 25;14:101. doi: 10.1186/s12911-014-0101-y. — View Citation
Edmonds SW, Solimeo SL, Lu X, Roblin DW, Saag KG, Cram P. Developing a bone mineral density test result letter to send to patients: a mixed-methods study. Patient Prefer Adherence. 2014 Jun 5;8:827-41. doi: 10.2147/PPA.S60106. eCollection 2014. — View Citation
Edmonds SW, Solimeo SL, Nguyen VT, Wright NC, Roblin DW, Saag KG, Cram P. Understanding Preferences for Osteoporosis Information to Develop an Osteoporosis Patient Education Brochure. Perm J. 2017;21:16-024. doi: 10.7812/TPP/16-024. Epub 2016 Nov 18. — View Citation
Edmonds SW, Wolinsky FD, Christensen AJ, Lu X, Jones MP, Roblin DW, Saag KG, Cram P; PAADRN Investigators. The PAADRN study: a design for a randomized controlled practical clinical trial to improve bone health. Contemp Clin Trials. 2013 Jan;34(1):90-100. doi: 10.1016/j.cct.2012.10.002. Epub 2012 Oct 17. — View Citation
Wolinsky FD, Lou Y, Edmonds SW, Hall SF, Jones MP, Wright NC, Saag KG, Cram P, Roblin DW; PAADRN Investigators. Activating Patients With a Tailored Bone Density Test Results Letter and Educational Brochure: the PAADRN Randomized Controlled Trial. J Clin D — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Guideline Concordant Osteoporosis Therapy | Guideline concordant was defined as those who prescribed a National Osteoporosis Foundation approved osteoporosis therapy for patients with osteoporosis (T-score of femoral neck, hip, or spine =-2.5 or FRAX =20 %), or patients with a self-reported history of low impact fracture, or patients with osteopenia (T-score between -1.0 and -2.5 at the femoral neck, hips, or lumbar spine) and a 10-year probability of a major osteoporosis-related fracture =20 % OR those who were not prescribed a therapy for patients with no self-reported history of prior DXA and study DXA shows normal BMD and no self-reported history of low impact fracture, or study DXA shows osteopenia (T-score of femoral neck, hip, or spine between -1 and -2.5) and FRAX <20 %) and no self-reported history of low impact fracture, or self-reported prior DXA but no self-reported history of low impact fracture and no self-reported history of osteoporosis. | 12 weeks after DXA |
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