Advanced Care Management in Patients With Advanced Heart Failure

June 18, 2020 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Zhongzheng
      • Taipei, Zhongzheng, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient with advanced heart disease and received medical treatment now.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months for each interval and 4 times on each patient (total 9 months on this study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Kai-di Kao, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201711101RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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