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Advanced Care Management in Patients With Advanced Heart Failure

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ClinicalTrials.gov Identifier: NCT03526627
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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
Advanced Heart Failure

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. advanced care management [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patient with advanced heart disease and received medical treatment now.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526627


Contacts
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Contact: Kai-di Kao +886928846909 keddy0717@gmail.com
Contact: Shiu-yu Chiu, PhD 886-2-2822-7101 ext 3316 shiuyu@ntunhs.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Zhongzheng, Taiwan, 100
Contact: Kai-di Kao    886-928846909    keddy0717@gmail.com   
Contact: Shiu-yu Chiu    886-2-2822-7101 ext 3316    shiuyu@ntunhs.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kai-di Kao National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03526627     History of Changes
Other Study ID Numbers: 201711101RIND
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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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:
advanced care management, advanced heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases