Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Advanced Care Management in Patients With Advanced Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03526627
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date March 6, 2018
First Posted Date May 16, 2018
Last Update Posted Date May 29, 2019
Actual Study Start Date January 4, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03526627 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Advanced Care Management in Patients With Advanced Heart Failure
Official Title Advanced Care Management in Patients With Advanced Heart Failure
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patient with advanced heart disease and received medical treatment now.
Condition Advanced Heart Failure
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 3, 2018)
227
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Kai-di Kao +886928846909 keddy0717@gmail.com
Contact: Shiu-yu Chiu, PhD 886-2-2822-7101 ext 3316 shiuyu@ntunhs.edu.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03526627
Other Study ID Numbers 201711101RIND
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Kai-di Kao National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date May 2019