NCT03526627

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 22, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

March 6, 2018

Last Update Submit

June 18, 2020

Conditions

Keywords

advanced care management, advanced heart failure

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

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

Study Officials

  • Kai-di Kao

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations