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

24. juli 2019 oppdatert 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

(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.

Studietype

Intervensjonell

Registrering (Forventet)

1000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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
Andre navn:
  • Subjects with CHF follow-up
Annen: 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
Aktiv komparator: Subjects with CHF conventional clinic visit
Subjects with standardized treatment according to latest guidelines via conventional visit.
Annen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
all cause mortality
Tidsramme: one year
Number of subjects with all cause death
one year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Heart failure morbidity
Tidsramme: one year
number of subjects with heart failure - related visits
one year

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Engasjement av intervensjonen
Tidsramme: 4 måneder
Det ble vurdert objektivt via daglige nettportalinnlogginger og bruk av mobil-APP
4 måneder
heart failure worsening
Tidsramme: 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
Tidsramme: one year
Hospitalization rate associated with heart failure
one year
Average hospitalization time
Tidsramme: one year
Average hospitalization time associated with heart failure
one year
Costs of medications
Tidsramme: one year
Costs of medications associated with heart failure
one year
Usability of the HCF intervention for patients
Tidsramme: 4 months
it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12)
4 months
Changes of self-management
Tidsramme: 4 months
Lifestyle and health behaviors of participants were collected by interview
4 months
Participants perceptions of intervention components
Tidsramme: 4 months
During the interview, qualitative method was used to examine participants perceptions of intervention components
4 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Xiang Gu

Samarbeidspartnere

Science and Technology Department of Jiangsu Province
Yangzhou Municipal Health Bureau

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2013

Primær fullføring (Forventet)

1. august 2020

Studiet fullført (Forventet)

1. desember 2020

Datoer for studieregistrering

Først innsendt

21. desember 2013

Først innsendt som oppfylte QC-kriteriene

5. januar 2014

Først lagt ut (Anslag)

7. januar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BL2013022

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