Hospital-Community-Family-Care Management Platform for Chronic Heart Failure (HCF-CMP-CHF)
2019년 7월 24일 업데이트: Xiang Gu
Remote Prevention and Treatment Based on Community Under the Guidance of Regional Central Hospital for Patients With Chronic Heart Failure
The purpose of this study is to determine whether the Hospital-Community-Family-Care Management Platform for Chronic Heart Failure reduces the mortality, readmission rates and costs of the subjects with CHF.
연구 개요
상태
알려지지 않은
정황
상세 설명
(1) Indication: Chronic Heart Failure.
(2) Objectives: Primary objective is to evaluate the efficacy of the Hospital-Community-Family-Care Management Platform online compared with the regular clinic follow up in subjects with CHF (I-IV class by NYHA, of which class IV without strict bed rest).Secondary objectives is to assess the safety of the Management Platform online in subjects with CHF.
(3) Study design: Prospective, randomized, controlled study with two follow up management groups: 1) the Hospital-Community-Family-Care Management Follow up Online; 2) the regular monthly clinic follow up.
Study population: Totally 1000 male and female subjects with CHF (I-IV functional class according to NYHA classification).
(4) Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
(5) Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
(6) Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources.
(7) Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
(8) Duration of follow up: The total follow-up time shall be at least 12 months.
(9) Safety Assessment: Safety of the study will be evaluated by the following assessments: 1) Subject and object examinations (during the follow up period and extending up to 2 week after the end of the study) consisting of a subject interview (including direct questioning about adverse events), physical examination, assessment of body weight, Electrocardiogram (ECG) and echocardiogram (UCG), Left ventricular ejection fraction (LVEF), assessed by echocardiography, The N-terminal prohormone of brain natriuretic peptide (NT-proBNP), a peptide hormone whose plasma concentration is inversely related to the severity of HF, NYHA functional status, assessed by subject interview, 6-minute walk distance (6MWD), Quality of life (QoL), assessed by the Minnesota Living with Heart Failure questionnaire (MLHFQ), a validated questionnaire assessing QoL in subjects with heart failure.
2) Evaluation of clinically relevant safety laboratory parameters, such as complete blood count, serum creatinine, electrolytes, and liver enzymes.
Any Adverse Events (AE) or Serious Adverse Events (SAE) and its potential causal relationship with the study will be recorded and evaluated.
연구 유형
중재적
등록 (예상)
1000
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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Jiangsu
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Yangzhou, Jiangsu, 중국, 225001
- 모병
- Department of cardiovascular medicine,Northern Jiangsu Hospital
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부수사관:
- Lei Sun, Master
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부수사관:
- Ye Zhu, Master
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부수사관:
- Shuhang Miao, Bachelor
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부수사관:
- Yi Zhang, Master
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부수사관:
- Zhengyu Bao, Doctor
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연락하다:
- Jianhua Shen, Doctor
- 전화번호: +86 0514 87373367
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부수사관:
- Ming Gu, Master
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부수사관:
- Hui Li, Bachler
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부수사관:
- Fei Hang, Master
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:Inclusion Criteria:to be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below at the time of screening and randomization:
- Male and female are aged 18 years old or over.
- History of CHF for ≥3 months with NYHA functional class I-IV, of which class IV without strict bed rest.
- Left ventricular ejection fraction (LVEF) ≤45% as assessed by echocardiogram. However, LVEF can be above 45% for patients with cardiac insufficiency caused by atrial fibrillation, valvular heart disease, hypertrophic cardiomyopathy and et al;
- Treatment of CHF with stable and optimal pharmacological therapy according to Chinese guidelines for treatment of CHF. In general, optimal treatment will include a beta-blocker and an ACE inhibitor and/or an angiotensin receptor blocker, unless not tolerated. Medical therapy is defined as stable, if the subject has not started a new CHF drug class and the dose of drugs taken have not been changed during the 3 months prior to screening and randomization.
- Ability to understand the requirements of the study and willingness to provide written informed consent (IC), and agreement to abide by the study restrictions and return for the required assessments.
- Subjects are located in our coverage of the remote monitoring system.
Exclusion Criteria:To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below at screening and randomization:
- Some secondary cardiomyopathy: hyperthyroid heart disease and anemic heart disease, and et al;
- A history of malignancy, and life expectancy is less than 1 year；
- Severe primary hepatic and renal insufficiency (alanine aminotransferase≥100 u/L, serum creatinine >3.0mg/dL, serum albumin <2.5g/L);
- Refusal to participate;
- Unable to visit outpatient clinics periodically;
- Ambulatory population;
- Patients were considered inappropriate to participate by researchers.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Subjects with CHF follow-up
Subjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up.In the program, participants were educated on the use of smart health-tracking devices and mobile application (APP) to collect and upload comprehensive data elements related to the risk of CHF self-care management.
They were also instructed to send text messages, view notifications, and receive individualized guidance on the mobile APP.
The general practitioners viewed index of each participant on mobile APP and provided primary care periodically, and cardiologists in regional central hospital offered remote guidance and management if necessary.
Outcomes assessed included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of heart failure-related health behaviors.
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Hospital-Community-Family-Care Management Platform Online: the remote monitoring service platform on line based on community and family for subjects with CHF under the guidance of the regional central hospital
다른 이름들:
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
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활성 비교기: Subjects with CHF conventional clinic visit
Subjects with standardized treatment according to latest guidelines via conventional visit.
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Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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all cause mortality
기간: one year
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Number of subjects with all cause death
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one year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Heart failure morbidity
기간: one year
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number of subjects with heart failure - related visits
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one year
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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개입 참여
기간: 4개월
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매일 웹 포털 로그인 및 모바일 APP 사용을 통해 객관적으로 평가되었습니다.
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4개월
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heart failure worsening
기간: one year
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Number of subjects requiring drug or dose changes to intensify concomitant therapy due to worsening of heart failure (HF).
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one year
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Hospitalization rate
기간: one year
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Hospitalization rate associated with heart failure
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one year
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Average hospitalization time
기간: one year
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Average hospitalization time associated with heart failure
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one year
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Costs of medications
기간: one year
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Costs of medications associated with heart failure
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one year
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Usability of the HCF intervention for patients
기간: 4 months
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it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12)
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4 months
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Changes of self-management
기간: 4 months
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Lifestyle and health behaviors of participants were collected by interview
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4 months
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Participants perceptions of intervention components
기간: 4 months
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During the interview, qualitative method was used to examine participants perceptions of intervention components
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4 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Xiang Gu, Docter, Department of cardiovascular medicine
- 수석 연구원: Jianhua Shen, Docter, Department of cardiovascular medicine
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
2013년 12월 1일
기본 완료 (예상)
2020년 8월 1일
연구 완료 (예상)
2020년 12월 1일
연구 등록 날짜
최초 제출
2013년 12월 21일
QC 기준을 충족하는 최초 제출
2014년 1월 5일
처음 게시됨 (추정)
2014년 1월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 7월 24일
마지막으로 확인됨
2019년 7월 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. .