Advanced Care Management in Patients With Advanced Heart Failure

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03526627
Collaborator
(none)
227
1
35.9
6.3

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the trajectory of advanced management care in patients with heart failure over a period of 9 months, then comparing the medical treatment accepted by patients after 2 years later and compliance with the preferences of patients and their families.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    this study is to observe the trajectory of the advanced care management on patients with advanced heart failure and follow the difference between the actual medical treatment accepted by patients on 2years later and the preference of the patient and their families.

    the advance care management in this study is mean the patients who know about the preference of medical treatment, communication, and prognosis of illness. we also measure the sense of coherence, self-efficacy and their quality of life to compare their relationship of the advanced care management.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    227 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Advanced Care Management in Patients With Advanced Heart Failure
    Actual Study Start Date :
    Jan 4, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    patient with advanced heart failure

    we included the patients with advanced heart failure who had the poor cardiac function(LVEF<=30%) and was admitted to the general ward or emergency room within one year.

    Outcome Measures

    Primary Outcome Measures

    1. advanced care management [3 months for each interval and 4 times on each patient (total 9 months on this study)]

      we use a modified questionnaire "assessment the medical needs and preference on terminal patients and their families (Tang, et al., 2004) by literature review and named "The prognosis and message status on patients with advanced Heart failure. the questionnaire include 3 parts: medical preference in their advanced status, communication between physician and patients and physician and their families ( the definition of families in this study is the major medical decision for the patients), and the knowledge of disease prognosis. The questionnaire include 17 items with continue and category variables. Before study we use expert validity from 5 experts who works in group at least 10 years. Each items is scored on a five-point Likert scale range from 0(not at all) to 4 (very appropriate to this study). The overall score was calculated as the average of all items and finally we got 3.67-points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • diagnosed with AHA stage D, or NYHA class function 4, or LVEF<=30%.

    • has one or more than one symptoms such as dyspnea, lower legs edema, weakness.

    • ever admission to the hospital (include emergency room or the general room)

    Exclusion Criteria:
    • with other end-stage diseases such cancer, dementia, COPD, ESRD...etc.

    • had other physical, cognitive, or psychological condition which may influence their answer.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Zhongzheng Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Kai-di Kao, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03526627
    Other Study ID Numbers:
    • 201711101RIND
    First Posted:
    May 16, 2018
    Last Update Posted:
    Jun 22, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2020