- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00567294
Evaluating Ways to Improve Medication Use Among People With Osteoporosis
Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: A
Participants will receive mailed education materials on osteoporosis and medication use.
|
Mailed education materials on osteoporosis and medication use over a 1-year period
|
|
실험적: B
Participants will receive a telephone coaching program.
|
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.
|
|
실험적: C
Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications.
|
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.
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Medication adherence
기간: At Month 12
|
At Month 12
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Medication persistence
기간: At Month 12
|
At Month 12
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Daniel H. Solomon, MD, MPH, Brigham and Women's Hospital
- 연구 책임자: Timothy Gleeson, BS, Brigham and Women's Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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