Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02115


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.


Study summary:

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:

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


Study is Available At:


Original ID:

P60 AR047782


NCT ID:

NCT00567294


Secondary ID:

P60AR047782


Study Acronym:


Brief Title:

Evaluating Ways to Improve Medication Use Among People With Osteoporosis


Official Title:

Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

65 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brigham and Women's Hospital


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

2087


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel H. Solomon, MD, MPH
Principal Investigator
Brigham and Women's Hospital

Study Dates

Start Date:November 2007
Completion Date:January 2011
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 14, 2012
First Received Date:November 30, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Medication persistence
Time Frame:At Month 12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Medication adherence
Time Frame:At Month 12
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Mailed education
Description:Mailed education materials on osteoporosis and medication use over a 1-year period
Arm Name:A
Intervention Type:Behavioral
Name:Telephone coaching program for patients
Description: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 t
Arm Name:B
Intervention Type:Behavioral
Name:Medication adherence alert program for doctors
Description: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.
Arm Name:C

Study Arms

Study Arm Type:Experimental
Arm Name:C
Description:Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications.
Study Arm Type:Experimental
Arm Name:B
Description:Participants will receive a telephone coaching program.
Study Arm Type:Active Comparator
Arm Name:A
Description:Participants will receive mailed education materials on osteoporosis and medication use.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brigham and Women's Hospital
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.