Experience in Being With Advanced Heart Failure Patients | NCT02437331

Studies
Experience in Being With Advanced Heart Failure Patients

NCT02437331

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Oct 13, 2016Estimated

Enrollment

18Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2017Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Apr 22, 2015

First Submission Date that Met QC Criteria

May 4, 2015

First Posted Date

May 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to explore the experience in being with advanced Heart failure patients.

Detailed Description

The aim is to explore the experience of advanced Heart failure patients during the disease trajectory in Taiwan.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
advanced heart failure		the patients was diagnostic on Chronic heart failure with NYHA class 3 and 4, AHA stage D, or LVEF<40%.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A qualitative research to decribe the experience with advanced Heart failure patients	describe patterns of diseases traits	participants will be followed for the duration of hospital stay, an expected average of 6 weeks.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

the patients' conscious must be clear,
vital sign is stable,
and can communicate in Mandarin Chinese or Taiwanese.

exclusion criteria:

consciousness is unclear
and can't have effective communication to interviewer.
the patient reject to join this study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

the study population is diagnosis of advanced heart failure with NYHA class 3 to 4.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
keidei kao, master	study	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei	Zhongzheng	10002	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

because the data is still discussing with professional expert. and we think the data is not reach saturation yet.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 11, 2017
Reset	Jun 26, 2017

Submission Tracking

Estimated Results First Submitted Date

Apr 11, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 11, 2017			Jun 26, 2017

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided