- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02378571
Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions (TEAM-HF)
2018년 1월 18일 업데이트: Ian Kronish, Columbia University
Telemonitoring Adherence to Medications to Reduce Heart Failure Readmissions: A Pilot Randomized Clinical Trial
The overall purpose of this project is to determine the feasibility of conducting a large scale randomized clinical trial that compares remote monitoring of adherence to loop diuretics using a wireless electronic pillcap with usual care among recently hospitalized heart failure patients.
The long-term goal of this program of research is to determine the effect of the adherence telemonitoring intervention on medication adherence and hospital readmissions among recently hospitalized heart failure patients.
연구 개요
상세 설명
Approximately one in four patients hospitalized with heart failure is readmitted within 30 days of discharge and more than 50% are readmitted within 6 months of discharge.
Heart failure admissions are a major contributor to the enormous health care costs associated with heart failure.
Thus far, the identification of effective interventions that prevent unnecessary readmissions has remained elusive.
As a result, there is a pressing need to identify novel, cost-effective approaches to reducing heart failure readmissions.
A growing body of research suggests that poor adherence to heart failure medications is a major reason for preventable heart failure readmissions.
In particular, loop diuretic medications are essential to preventing the cardiopulmonary system from becoming overloaded.
Patients who have been recently hospitalized may be especially vulnerable to adherence problems as a result of the stress of the recent hospitalization which commonly induces sleep deprivation, nutritional deficiency, physical deconditioning, cognitive impairment, and even delirium.
Recent advances in wireless health now enable us to remotely, unobtrusively, and objectively monitor adherence to heart failure medications in the post-discharge period.
Early identification of non-adherence to loop diuretic medications has the prevention to prevent a volume overloaded state that leads to a heart failure readmission.
As patients who are non-adherent to their loop diuretics may also be non-adherent to other recommended self-management behaviors, early identification of medication nonadherence may provide the context to identify other gaps in self-management.
To test our hypothesis that it is feasible to conduct a randomized trial of wireless, medication adherence monitoring with feedback to patients and clinicians, the investigators will enroll 40 patients who are hospitalized for heart failure and discharged on a diuretic medication.
Patients will be randomized to 1) usual heart failure care + telemonitoring adherence to diuretic medications (INT); N=20 or 2) usual heart failure care (CTR); N=20.
All patients will be asked to take their diuretic medication from a standard pill bottle covered by an electronic pill cap (GlowCap), but only patients assigned to the intervention arm will have their adherence telemonitored by a study clinician in real-time.
Patients will have their adherence to medications measured in this fashion for 30 days after discharge.
Patients will be contacted at 30 days to determine if they have been hospitalized and to collect other self-reported outcomes data.
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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New York, New York, 미국, 10032
- Columbia University Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Hospitalized for heart failure
- Prescribed loop diuretic medication at discharge
Exclusion Criteria:
- Age less than 21 years
- New York Heart Association Class IV heart failure
- Terminal illness (<6 mo prognosis)
- Unable to self-administer medications due to mental illness or cognitive impairment
- Non-English/Spanish speaking
- Discharged to an institutional setting (e.g., nursing home)
- Cardiologist or primary care provider refusal
- Unavailable for follow-up
- No access to telephone
- Enrolled in another cardiac trial
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Usual care
Participants assigned to usual care will also be provided with a GlowCap prior to discharge and will be instructed to take their loop diuretic from this bottle and to notify the study team about prescribed dose changes.
This information, however, will solely be used to measure medication adherence and will not be provided to a member of the study team nor to any of the participants' health care providers until the completion of the study period, at least 1 month later.
Participants will not be provided with any advice on heart failure adherence.
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실험적: Medication adherence telemonitoring
At discharge, participants in the intervention group will be instructed to take their loop diuretic exclusively from the GlowCap in the manner prescribed by their physician.
A study team member will review the adherence data on a daily basis (except holidays and weekends) during the first 7 days after discharge, and then on, at minimum, a weekly basis.
The study team member will respond to adherence data using clinical judgment as they would if the information was obtained during clinical care.
Specifically, when contacting nonadherent participants, the member of the study team will provide participants with feedback on their electronic adherence; will inquire about potential consequences of missed doses; and will assess and respond to reasons for missed doses.
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The member of the study team will respond to adherence data using clinical judgment as they would if the information was obtained during clinical care.
Specifically, when contacting nonadherent participants, the member of the study team will provide participants with feedback on their electronic adherence; will inquire about potential consequences of missed doses; and will assess and respond to reasons for missed doses.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of days participants take the correct number of doses of their diuretic
기간: 30 days post-discharge
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Loop diuretic adherence: Adherence to the diuretic medication will be electronically measured using GlowCaps (Vitality Inc.) in the 30 days after hospitalization.
Medication adherence will be calculated as the percent of days participants take the correct number of doses of their diuretic.
Days when participants are incapable of taking their medication from the GlowCap bottle (e.g., while hospitalized) will be censored from calculations.
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30 days post-discharge
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Score on the Self Care Heart Failure Index
기간: 30 days post-discharge
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Heart Failure Symptoms, Self-Efficacy for self-managing heart failure, and Self-Management Behaviors will be measured using Self Care Heart Failure Index
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30 days post-discharge
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Proportion very or extremely satisfied with heart failure care
기간: 30 days post-discharge
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Satisfaction with Heart Failure Care will be assessed by asking participants "Overall, how satisfied are you with the care you have been receiving for your heart problems over the last 30 days?" Response options will include: "not at all satisfied", "a little satisfied", "very satisfied," and "extremely satisfied."
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30 days post-discharge
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Number of readmissions and emergency room visits
기간: 30 days post-discharge
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Readmissions and emergency room visits will be assessed by contacting participants or their close contacts at 30 days.
Hospital records will be reviewed to confirm readmissions, to determine the reason for readmission or emergency room visit (heart failure versus other), and to determine whether it was related to medication nonadherence.
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30 days post-discharge
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Proportion attending at least 1 scheduled outpatient clinic visit within 30 days of discharge
기간: 30 days post-discharge
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Attendance at scheduled outpatient clinic visits will be assessed by contacting participants or their close contacts at 30 days.
Hospital records will be reviewed, when available, to determine whether and how medication adherence was addressed during the visit.
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30 days post-discharge
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ian M Kronish, MD, MPH, Columbia University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 12월 1일
기본 완료 (실제)
2015년 10월 1일
연구 완료 (실제)
2015년 11월 1일
연구 등록 날짜
최초 제출
2015년 2월 27일
QC 기준을 충족하는 최초 제출
2015년 3월 3일
처음 게시됨 (추정)
2015년 3월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 1월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 1월 18일
마지막으로 확인됨
2018년 1월 1일
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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