Hospital-Community-Family-Care Management Platform for Chronic Heart Failure (HCF-CMP-CHF)
2019年7月24日 更新者：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.
調査の概要
状態
わからない
条件
詳細な説明
(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.
研究の種類
介入
入学 (予想される)
1000
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Jiangsu
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Yangzhou、Jiangsu、中国、225001
- 募集
- Department of cardiovascular medicine,Northern Jiangsu Hospital
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副調査官：
- Lei Sun, Master
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副調査官：
- Ye Zhu, Master
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副調査官：
- Shuhang Miao, Bachelor
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副調査官：
- Yi Zhang, Master
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副調査官：
- Zhengyu Bao, Doctor
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コンタクト：
- Jianhua Shen, Doctor
- 電話番号：+86 0514 87373367
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副調査官：
- Ming Gu, Master
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副調査官：
- Hui Li, Bachler
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副調査官：
- Fei Hang, Master
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
all cause mortality
時間枠：one year
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Number of subjects with all cause death
|
one year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart failure morbidity
時間枠：one year
|
number of subjects with heart failure - related visits
|
one year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
介入の関与
時間枠：4ヶ月
|
毎日の Web ポータルへのログインとモバイルアプリの使用を通じて客観的に評価されました。
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4ヶ月
|
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heart failure worsening
時間枠：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).
|
one year
|
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Hospitalization rate
時間枠：one year
|
Hospitalization rate associated with heart failure
|
one year
|
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Average hospitalization time
時間枠：one year
|
Average hospitalization time associated with heart failure
|
one year
|
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Costs of medications
時間枠：one year
|
Costs of medications associated with heart failure
|
one year
|
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Usability of the HCF intervention for patients
時間枠：4 months
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it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12)
|
4 months
|
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Changes of self-management
時間枠：4 months
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Lifestyle and health behaviors of participants were collected by interview
|
4 months
|
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Participants perceptions of intervention components
時間枠：4 months
|
During the interview, qualitative method was used to examine participants perceptions of intervention components
|
4 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Xiang Gu, Docter、Department of cardiovascular medicine
- 主任研究者：Jianhua Shen, Docter、Department of cardiovascular medicine
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年12月1日
一次修了 (予想される)
2020年8月1日
研究の完了 (予想される)
2020年12月1日
試験登録日
最初に提出
2013年12月21日
QC基準を満たした最初の提出物
2014年1月5日
最初の投稿 (見積もり)
2014年1月7日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月26日
QC基準を満たした最後の更新が送信されました
2019年7月24日
最終確認日
2019年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。