Condition category
Circulatory System
Date applied
24/09/2019
Date assigned
25/09/2019
Last edited
25/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with reduced ejection fraction have high rates of mortality and readmission after hospitalization for heart failure. In Taiwan, heart failure disease management programs (HFDMPs) have proven effective for reducing readmissions for decompensated heart failure or other cardiovascular causes by up to 30%. However, the benefits of HFDMP in different populations of heart failure patients is unknown.

Who can participate?
Patients admitted for systolic heart failure with reduced EF radiographic evidence of pulmonary congestion or typical symptoms and signs of HF, aged over 18, and NYHA functional class II-IV

What does the study involve?
This study compares mortality and readmission in heart failure patients who participated in heart failure disease management programs (HFDMP group) and heart failure patients who received standard care (non-HFDMP group) over a 1-year follow-up period after discharge. The HFDMPs include a patient education program delivered by the lead nurse of the HFDMP; a cardiac rehabilitation program provided by a physical therapist; consultation with a dietician, and consultation and assessment by a psychologist. The patients are followed up for at least 1 year after discharge or until death. Patient characteristics and clinical demographic data are compared between the two groups.

What are the possible benefits and risks of participating?
Possible benefits include improved survival, reduced readmission, improved life quality and exercise capacity. There are no risks of participating.

Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
January 2013 to December 2016

Who is funding the study?
Chang Gung Medical Foundation (Taiwan)

Who is the main contact?
Dr Shyh-Ming Chen
syming99@cgmh.org.tw

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shyh Ming Chen

ORCID ID

Contact details

123 Ta Pei Rd.
Niao Sung Dist.
Kaohsiung City
83301
Taiwan
+886 (0)773171238300
syming99@cgmh.org.tw

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Impact of multi-disciplinary treatment strategy on systolic heart failure outcome

Acronym

Study hypothesis

The multi-discipline disease management program is beneficial for heart failure patients.

Ethics approval

Approved 02/09/2015, Chang Gung Medical Foundation Institutional Review Board (199, Tung Hwa North Rd. Taipei, Taiwan, ROC 10507; Tel: +886 (0)3 3196200; Email: violet1202@cgmh.org.tw), IRB no.: 104-5591B

Study design

Longitudinal case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Heart failure with reduced ejection fraction

Intervention

This observational cohort study compared mortality and readmission in heart failure patients who participated in a heart failure disease management programs (HFDMP group) and heart failure patients who received standard care (non-HFDMP group) over a 1-year follow-up period after discharge (December 2014 retrospectively registered). The components of the intervention program included a patient education program delivered by the lead nurse of the HFDMP; a cardiac rehabilitation program provided by a physical therapist; consultation with a dietician, and consultation and assessment by a psychologist. The patients were followed up for at least 1 year after discharge or until death. Patient characteristics and clinical demographic data were compared between the two groups. Cox proportional hazards regression analysis was performed to calculate hazard ratios (HRs) for death or recurrent events of hospitalization in the HFDMP group in comparison with the non-HFDMP group while controlling for covariates.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Recurrent events of hospitalization assessed using medical records and telephone contact at one year

Secondary outcome measures

Total mortality assessed using medical records and telephone contact at one year

Overall trial start date

01/01/2013

Overall trial end date

31/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. HF patients admitted to hospital with reduced EF (EF<40%)
2. Radiographic evidence of pulmonary congestion or typical symptoms and signs of HF
3. Age > 18 years
4. NYHA functional class II-IV

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

159

Participant exclusion criteria

1. Severe respiratory failure under ventilator support
2. Dementia
3. Expectation of short survival
4. Discharge to a geriatric clinic or home care
5. Current follow-up treatment at the nurse-led HF clinic

Recruitment start date

01/07/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Taiwan

Trial participating centre

Kaohsiung Chang Gung Memorial Hospital
123 Ta Pei Rd., Niao Sung Dist.
Kaohsiung City
83301
Taiwan

Sponsor information

Organisation

Chang Gung Medical Foundation

Sponsor details

123 Ta Pei Rd.
Niao Sung Dist.
Kaohsiung City
83301
Taiwan
+886 (0)773171238300
syming99@cgmh.org.tw

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Chang Gung Medical Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Taiwan

Results and Publications

Publication and dissemination plan

Planned publication in BMC Cardiovascular Disorders

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Shyh-Ming Chen ( syming99@gmail.com) and Yu-Tung Huang (anton.huang@gmail.com).

Intention to publish date

01/10/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/09/2019: Trial's existence confirmed by ethics committee.