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| Sponsor: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00567294 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Behavioral: Mailed education Behavioral: Telephone coaching program for patients Behavioral: Medication adherence alert program for doctors |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial |
| Estimated Enrollment: | 2200 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Participants will receive mailed education materials on osteoporosis and medication use.
|
Behavioral: Mailed education
Mailed education materials on osteoporosis and medication use over a 1-year period
|
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Experimental: B
Participants will receive a telephone coaching program.
|
Behavioral: Telephone coaching program for patients
A telephone coaching program that will involve twelve 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; phone calls will also include specially tailored education on osteoporosis and fracture prevention. A close family member or friend of the participant will also be contacted via phone two times during the study by the health educator. 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.
|
|
Experimental: C
Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications.
|
Behavioral: Telephone coaching program for patients
A telephone coaching program that will involve twelve 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; phone calls will also include specially tailored education on osteoporosis and fracture prevention. A close family member or friend of the participant will also be contacted via phone two times during the study by the health educator. 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.
Behavioral: Medication adherence alert program for doctors
Doctors of participants will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among people with osteoporosis. Doctors will also receive alerts on any patients who are not filling their medication prescriptions.
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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.
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Timothy Gleeson, BS | 617-732-4318 | tgleeson@partners.org |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Daniel H. Solomon, MD, MPH | |
| Principal Investigator: | Daniel H. Solomon, MD, MPH | Brigham and Women's Hospital |
| Study Director: | Timothy Gleeson, BS | Brigham and Women's Hospital |
More Information
| Responsible Party: | Daniel H. Solomon, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00567294 History of Changes |
| Other Study ID Numbers: | P60 AR047782, P60 AR047782-06A1 |
| Study First Received: | November 30, 2007 |
| Last Updated: | March 31, 2009 |
| Health Authority: | United States: Federal Government |
|
Osteoporosis Medication adherence Telephonic education Motivational interviewing |
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Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |