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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03526627
Other study ID # 201711101RIND
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2018
Est. completion date December 31, 2020

Study information

Verified date May 2020
Source National Taiwan University Hospital
Contact Kai-di Kao
Phone +886928846909
Email keddy0717@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 227
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei Zhongzheng

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary advanced care management 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. 3 months for each interval and 4 times on each patient (total 9 months on this study)
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