Evaluating Ways to Improve Medication Use Among People With Osteoporosis - NCT00567294-02115 (Clinical Trial 192920)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy192920.aspx
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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Osteoporosis |
| Purpose: |
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Osteoporosis is a common bone disease in older adults in which the bones become weaker and
prone to fracture. Medications are available to slow or even stop disease progression.
However, very few adults who are prescribed osteoporosis medications actually follow through
with filling their prescriptions and taking the medications. Ways to improve medication use
have not been well developed or adequately tested. The purpose of this study is to evaluate
a telephone coaching program, with or without helpful adherence notifications to doctors, in
improving treatment adherence in older adults who are starting an osteoporosis medication.
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| Study summary: |
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Fractures associated with osteoporosis are expected to rise to 3 million by 2025 with a cost
of $25 billion in medical costs. Many of these fractures could be avoided through preventive
measures, such as improved implementation of fall reduction strategies and use of effective
medications. While medications can significantly reduce the chance of fractures among adults
with osteoporosis, alarmingly few at-risk adults use osteoporosis treatments regularly. Only
10% to 30% of at-risk adults ever initiate osteoporosis medications, and of those, only 40%
to 50% continue to fill their prescriptions after 1 year. There is a clear need to develop
ways for improving adherence with osteoporosis medication regimens. The purpose of this
study is to evaluate a telephone coaching program, with or without helpful adherence
notifications to doctors, in improving treatment adherence in older adults who are starting
an osteoporosis medication.
Participation in this study will last 1 year. Through random assignment of doctor practices,
participants will fall into one of three groups.
- Group A participants will receive mailed education materials on osteoporosis and
medication use throughout the 1-year study.
- Group B participants will receive monthly 5- to 10-minute phone calls from a health
educator who is specially trained in osteoporosis. The phone calls will involve
coaching participants on behavioral reinforcement strategies that will help them to
continue taking their medications on schedule. Participants will also receive specially
tailored education on osteoporosis and fracture prevention during the phone calls. A
close family member or friend of the participant will be contacted via phone two times
during the study year. During these phone calls, the family member or friend will learn
how to support the participant in such a way that medication adherence is more likely.
- Group C participants will receive the same treatment as Group B. Doctors assigned to
Group C will receive written educational information on the rates of medication
adherence, implications of nonadherence, and methods for improving adherence among
patients. Doctors will also receive alerts about any of their participating patients
who are not filling medication prescriptions. The alert message will be provided in
both paper and electronic format. The electronic format can be easily formatted,
allowing the doctor to send a personalized letter to their patients.
At the end of the study, all participants will complete a mailed questionnaire on their
behaviors and demographics. Doctors will complete a mailed questionnaire aimed at
determining what parts of the interventions were well received. The occurrence of hip,
forearm, and/or upper arm fractures will be evaluated using Medicare claims data. |
| Criteria: |
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Inclusion Criteria:
- Patients enrolled in the Pharmaceutical Assistance Contract for the Elderly (PACE)
program at the Pennsylvania Department of Aging who begin taking a medication for
osteoporosis
Exclusion Criteria:
- Unable to communicate over the telephone with health educators |
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| Study is available at: |
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Brigham and Women's Hospital
Boston, MA 02115
United States
Primary Contact:
Timothy Gleeson, BS
Email: tgleeson@partners.org
Phone: 617-732-4318 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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