Advanced Care Management in Patients With Advanced Heart Failure
1 other identifier
observational
227
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2018
CompletedFirst Submitted
Initial submission to the registry
March 6, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 22, 2020
May 1, 2020
3 years
March 6, 2018
June 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
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.
Eligibility Criteria
patient with advanced heart disease and received medical treatment now.
You may qualify if:
- 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)
You may not qualify if:
- with other end-stage diseases such cancer, dementia, COPD, ESRD...etc.
- had other physical, cognitive, or psychological condition which may influence their answer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Zhongzheng, 100, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Kai-di Kao
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2018
First Posted
May 16, 2018
Study Start
January 4, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
June 22, 2020
Record last verified: 2020-05