Advanced Care Management in Patients With Advanced Heart Failure

Advanced Heart Failure Clinical Trial

Official title:

Advanced Care Management in Patients With Advanced Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03526627
• Other study ID #: 201711101RIND
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Heart Failure
• Heart Failure

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)