Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Hospital-Community-Family-Care Management Platform for Chronic Heart Failure (HCF-CMP-CHF)

24 luglio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

(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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

1000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Jiangsu
      • Yangzhou, Jiangsu, Cina, 225001
        • Reclutamento
        • Department of cardiovascular medicine,Northern Jiangsu Hospital
        • Sub-investigatore:
          • Lei Sun, Master
        • Sub-investigatore:
          • Ye Zhu, Master
        • Sub-investigatore:
          • Shuhang Miao, Bachelor
        • Sub-investigatore:
          • Yi Zhang, Master
        • Sub-investigatore:
          • Zhengyu Bao, Doctor
        • Contatto:
          • Jianhua Shen, Doctor
          • Numero di telefono: +86 0514 87373367
        • Sub-investigatore:
          • Ming Gu, Master
        • Sub-investigatore:
          • Hui Li, Bachler
        • Sub-investigatore:
          • Fei Hang, Master

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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:

  1. Male and female are aged 18 years old or over.
  2. History of CHF for ≥3 months with NYHA functional class I-IV, of which class IV without strict bed rest.
  3. 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;
  4. 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.
  5. 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.
  6. 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:

  1. Some secondary cardiomyopathy: hyperthyroid heart disease and anemic heart disease, and et al;
  2. A history of malignancy, and life expectancy is less than 1 year；
  3. Severe primary hepatic and renal insufficiency (alanine aminotransferase≥100 u/L, serum creatinine >3.0mg/dL, serum albumin <2.5g/L);
  4. Refusal to participate;
  5. Unable to visit outpatient clinics periodically;
  6. Ambulatory population;
  7. Patients were considered inappropriate to participate by researchers.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Hospital-Community-Family-Care Management Platform Online
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
Altri nomi:
  • Subjects with CHF follow-up
Altro: Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Comparatore attivo: Subjects with CHF conventional clinic visit
Subjects with standardized treatment according to latest guidelines via conventional visit.
Altro: Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
all cause mortality
Lasso di tempo: one year
Number of subjects with all cause death
one year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Heart failure morbidity
Lasso di tempo: one year
number of subjects with heart failure - related visits
one year

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Coinvolgimento dell'intervento
Lasso di tempo: 4 mesi
È stato valutato oggettivamente tramite accessi giornalieri al portale Web e utilizzo dell'APP mobile
4 mesi
heart failure worsening
Lasso di tempo: one year
Number of subjects requiring drug or dose changes to intensify concomitant therapy due to worsening of heart failure (HF).
one year
Hospitalization rate
Lasso di tempo: one year
Hospitalization rate associated with heart failure
one year
Average hospitalization time
Lasso di tempo: one year
Average hospitalization time associated with heart failure
one year
Costs of medications
Lasso di tempo: one year
Costs of medications associated with heart failure
one year
Usability of the HCF intervention for patients
Lasso di tempo: 4 months
it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12)
4 months
Changes of self-management
Lasso di tempo: 4 months
Lifestyle and health behaviors of participants were collected by interview
4 months
Participants perceptions of intervention components
Lasso di tempo: 4 months
During the interview, qualitative method was used to examine participants perceptions of intervention components
4 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Xiang Gu

Collaboratori

Science and Technology Department of Jiangsu Province
Yangzhou Municipal Health Bureau

Investigatori

  • Investigatore principale: Xiang Gu, Docter, Department of cardiovascular medicine
  • Investigatore principale: Jianhua Shen, Docter, Department of cardiovascular medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2013

Completamento primario (Anticipato)

1 agosto 2020

Completamento dello studio (Anticipato)

1 dicembre 2020

Date di iscrizione allo studio

Primo inviato

21 dicembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

5 gennaio 2014

Primo Inserito (Stima)

7 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BL2013022

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi