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

24 juillet 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

(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.

Type d'étude

Interventionnel

Inscription (Anticipé)

1000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Jiangsu
      • Yangzhou, Jiangsu, Chine, 225001
        • Recrutement
        • Department of cardiovascular medicine,Northern Jiangsu Hospital
        • Sous-enquêteur:
          • Lei Sun, Master
        • Sous-enquêteur:
          • Ye Zhu, Master
        • Sous-enquêteur:
          • Shuhang Miao, Bachelor
        • Sous-enquêteur:
          • Yi Zhang, Master
        • Sous-enquêteur:
          • Zhengyu Bao, Doctor
        • Contact:
          • Jianhua Shen, Doctor
          • Numéro de téléphone: +86 0514 87373367
        • Sous-enquêteur:
          • Ming Gu, Master
        • Sous-enquêteur:
          • Hui Li, Bachler
        • Sous-enquêteur:
          • Fei Hang, Master

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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
Autres noms:
  • Subjects with CHF follow-up
Autre: 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
Comparateur actif: Subjects with CHF conventional clinic visit
Subjects with standardized treatment according to latest guidelines via conventional visit.
Autre: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
all cause mortality
Délai: one year
Number of subjects with all cause death
one year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Heart failure morbidity
Délai: one year
number of subjects with heart failure - related visits
one year

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Engagement de l'intervention
Délai: 4 mois
Il a été évalué objectivement via des connexions quotidiennes au portail Web et l'utilisation de l'application mobile
4 mois
heart failure worsening
Délai: 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
Délai: one year
Hospitalization rate associated with heart failure
one year
Average hospitalization time
Délai: one year
Average hospitalization time associated with heart failure
one year
Costs of medications
Délai: one year
Costs of medications associated with heart failure
one year
Usability of the HCF intervention for patients
Délai: 4 months
it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12)
4 months
Changes of self-management
Délai: 4 months
Lifestyle and health behaviors of participants were collected by interview
4 months
Participants perceptions of intervention components
Délai: 4 months
During the interview, qualitative method was used to examine participants perceptions of intervention components
4 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Xiang Gu

Collaborateurs

Science and Technology Department of Jiangsu Province
Yangzhou Municipal Health Bureau

Les enquêteurs

  • Chercheur principal: Xiang Gu, Docter, Department of cardiovascular medicine
  • Chercheur principal: Jianhua Shen, Docter, Department of cardiovascular medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2013

Achèvement primaire (Anticipé)

1 août 2020

Achèvement de l'étude (Anticipé)

1 décembre 2020

Dates d'inscription aux études

Première soumission

21 décembre 2013

Première soumission répondant aux critères de contrôle qualité

5 janvier 2014

Première publication (Estimation)

7 janvier 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 juillet 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 juillet 2019

Dernière vérification

1 juillet 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BL2013022

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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