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

24 juli 2019 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

(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.

Studietyp

Interventionell

Inskrivning (Förväntat)

1000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Jiangsu
      • Yangzhou, Jiangsu, Kina, 225001
        • Rekrytering
        • Department of cardiovascular medicine,Northern Jiangsu Hospital
        • Underutredare:
          • Lei Sun, Master
        • Underutredare:
          • Ye Zhu, Master
        • Underutredare:
          • Shuhang Miao, Bachelor
        • Underutredare:
          • Yi Zhang, Master
        • Underutredare:
          • Zhengyu Bao, Doctor
        • Kontakt:
          • Jianhua Shen, Doctor
          • Telefonnummer: +86 0514 87373367
        • Underutredare:
          • Ming Gu, Master
        • Underutredare:
          • Hui Li, Bachler
        • Underutredare:
          • Fei Hang, Master

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
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
Andra namn:
  • Subjects with CHF follow-up
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Aktiv komparator: Subjects with CHF conventional clinic visit
Subjects with standardized treatment according to latest guidelines via conventional visit.
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
all cause mortality
Tidsram: one year
Number of subjects with all cause death
one year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Heart failure morbidity
Tidsram: one year
number of subjects with heart failure - related visits
one year

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Engagemang av interventionen
Tidsram: 4 månader
Det utvärderades objektivt via dagliga webbportalinloggningar och användning av den mobila APP
4 månader
heart failure worsening
Tidsram: 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
Tidsram: one year
Hospitalization rate associated with heart failure
one year
Average hospitalization time
Tidsram: one year
Average hospitalization time associated with heart failure
one year
Costs of medications
Tidsram: one year
Costs of medications associated with heart failure
one year
Usability of the HCF intervention for patients
Tidsram: 4 months
it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12)
4 months
Changes of self-management
Tidsram: 4 months
Lifestyle and health behaviors of participants were collected by interview
4 months
Participants perceptions of intervention components
Tidsram: 4 months
During the interview, qualitative method was used to examine participants perceptions of intervention components
4 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2013

Primärt slutförande (Förväntat)

1 augusti 2020

Avslutad studie (Förväntat)

1 december 2020

Studieregistreringsdatum

Först inskickad

21 december 2013

Först inskickad som uppfyllde QC-kriterierna

5 januari 2014

Första postat (Uppskatta)

7 januari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 juli 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2019

Senast verifierad

1 juli 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • BL2013022

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Kronisk hjärtsvikt

Kliniska prövningar på Hospital-Community-Family-Care Management Platform Online

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