NCT03447392

Brief Summary

Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education alone is not known. The investigators hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

August 21, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

February 16, 2018

Last Update Submit

February 26, 2018

Conditions

Heart Failure

Keywords

Patient EducationChinese Medicine

Outcome Measures

Primary Outcomes (1)

  • total number of days hospitalized

    total number of days hospitalized in the 84-day follow-up period.

    84 days

Study Arms (2)

patient education and Chinese medicine

EXPERIMENTAL

1-hour, one-on-one teaching session with a educator to the standard discharge education of Integrated Traditional and Western Medicine

Behavioral: Discharge Education of Chinese Medicine

patient education

NO INTERVENTION

no discharge education

Interventions

Discharge Education of Chinese MedicineBEHAVIORAL

Discharge Education of Integrated Traditional and Western Medicine

patient education and Chinese medicine

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates for this study were admitted to the hospital with a diagnosis of heart failure and documented left ventricular systolic dysfunction (ejection fraction\<0.40).

You may not qualify if:

  • CKD4 and CKD5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510405, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Xu ZOU

    The Second Clinical College, Guangzhou University of Chinese Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 27, 2018

Study Start

August 21, 2017

Primary Completion

January 8, 2018

Study Completion

January 8, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

CN(1)