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临床试验/NCT00567294
NCT00567294已完成3 期

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

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 2,087 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
2,087
试验地点
2
主要终点
Medication adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Unable to communicate over the telephone with health educators

结局指标

主要结局

Medication adherence

时间窗: At Month 12

次要结局

  • Medication persistence(At Month 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel H. Solomon, M.D.,MPH

Associate Professor

Brigham and Women's Hospital

研究点 (2)

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