- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01449695
Intervention to Improve Medication Adherence in Cardiovascular Patients
Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients.
연구 개요
상태
정황
상세 설명
Poor adherence to medication is one of the limitations in the treatment of cardiovascular disease. As a consequence the risk of premature death, hospital admissions and related costs is increasing. Therefore, detection of apparent poor adherence and interventions to improve adherence, are of great importance to enhance cardiovascular risk management over time.
This study is a prospective randomized trial, which compares 1) usual care with 2) the effect of a personalized visualization of cardiovascular risk levels (website) to support self management and 3) the additional effect of a communication intervention by a nurse on adherence on top of 2). Adherence is determined and continuously monitored with a dedicated calculation of refill data obtained from patient's pharmacy.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Nijmegen, 네덜란드, 6500 HB
- Radboud University Medical Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All subsequent patients, included in the hospital-screening program with manifestations of atherosclerotic disease (acute coronary syndrome, peripheral arterial disease or stroke/TIA) or elevated cardiovascular risk due to hypertension, diabetes or hyperlipidemia.
Exclusion Criteria:
- Age below 18 years, actual pregnancy, problems with Dutch language or logistic problems, which may hinder intervention on adherence behavior. Severe co-morbidity, including mental handicap, according to their physician.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Lifestyle counseling
Group consultation and individual nurse consultation
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A nurse-based intervention with face-to-face contacts based on motivational interviewing techniques and influence on behavioral determinants.
Well-trained nurses in our hospital will apply these behavioral change interventions.
An individual contact will take about twenty minutes.
This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors.
These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient.
The results of the screening and the two additional visits can be seen by the patient.
group consultations with peers and a nurse individual consultation with a nurse
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실험적: e health
An individual web based entry
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This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors.
These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient.
The results of the screening and the two additional visits can be seen by the patient.
|
간섭 없음: usual care
Usual care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in degree of Adherence
기간: Change from baseline in degree of Adherence at 12 month
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The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data
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Change from baseline in degree of Adherence at 12 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Clinical outcome
기간: Change from baseline in level of LDL-Cholesterol at 12 months
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Change in LDL-Cholesterol level in each group at 12 months from baseline
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Change from baseline in level of LDL-Cholesterol at 12 months
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Clinical outcome
기간: Change from baseline in Sytolic Blood Pressure at 12 months
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Change in Systolic Blood Pressure in each group at 12 months from baseline
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Change from baseline in Sytolic Blood Pressure at 12 months
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Clinical outcome
기간: Change from baseline in Body Mass Index at 12 months
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Change in Body Mass Index (BMI) in each group at 12 months from baseline
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Change from baseline in Body Mass Index at 12 months
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Clinical outcome
기간: Change from baseline in Waist Circumference at 12 months
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Change in Waist Circumference in each group at 12 months from baseline
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Change from baseline in Waist Circumference at 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Bas JH Bredie, MD, Radboud University Medical Center
간행물 및 유용한 링크
일반 간행물
- Sieben A, van Onzenoort HA, van Dulmen S, van Laarhoven C, Bredie SJ. A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial. Patient Prefer Adherence. 2019 May 23;13:837-852. doi: 10.2147/PPA.S197481. eCollection 2019.
- Sieben A, van Onzenoort HA, van Laarhoven KJ, Bredie SJ. A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the MIRROR Trial. JMIR Res Protoc. 2016 Sep 13;5(3):e187. doi: 10.2196/resprot.5750.
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 (실제)
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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