Determining the effect of home care program on readmission rate of patients with advanced heart failure
Design
The present study was a clinical trial. 80 patients with heart failure were randomly divided into experimental (n = 40) and control (n = 40) groups. The block randomization was used to randomly assign to the control or experience group.
Settings and conduct
Rajaie Cardiovascular Medical and Research Center
Participants/Inclusion and exclusion criteria
1)Patients diagnosed with advanced heart failure who are hospitalized in one of the wards of Shahid Rajaee Hospital, have LVEF< 30%, according to the NYHA classification, have class III-IV symptoms of heart failure 2)Have a history of admission more than 1 time within the past 6 months 3) aged 18 or over. 4) Satisfaction to participate in the study. 5) live in Tehran 6) Have not had cardiogenic shock in the last 4 weeks 7) do not need dialysis 8) do not have severe cognitive impairment and severe chronic disease
Intervention groups
For the experimental group, the home care program was implemented for 6 months. The nurses participating in the study, visited the patients' homes once every two weeks and telephone follow-up was done every 3 days. In the control group, all steps and measurements were the same except for the home care program.
Main outcome variables
number of hospitalization, number of hospital days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190205042636N2
Registration date:2020-07-25, 1399/05/04
Registration timing:retrospective
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Fidan Shabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4424 8029
Email address
fidannahal@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
2018-03-20, 1396/12/29
Scientific title
Effect of Home care Program on Re-hospitalization in Advanced Heart Failure
Public title
Effect of Home care Program on Re-hospitalization in Advanced Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with advanced heart failure who are hospitalized in one of the wards of Shahid Rajaee Hospital
have LVEF< 30%
according to the NYHA classification, have class III-IV symptoms of heart failure
Have a history of admission more than 1 time within the past 6 months
aged 18 or over.
Satisfaction to participate in the study
live in Tehran
Exclusion criteria:
cardiogenic shock in the last 4 weeks
need dialysis
severe cognitive impairment and severe chronic disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization was used to randomly assign to the control or experience group.Patients who met the inclusion criteria were randomly assigned to the experimental or control group based on a quadruple block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Rajaei Cardiovascular Medical and Research Center
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park,Vali Asr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2017-08-26, 1396/06/04
Ethics committee reference number
RHC.AC.IR.REC.1396.36
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
number of hospitalization
Timepoint
30, 90 and 180 days before and after the home care program
Method of measurement
Registration form for the hospitalization of a patient with heart failure in a hospital
2
Description
number of hospital days
Timepoint
30, 90 and 180 days before and after the home care program
Method of measurement
Registration form for the hospital days of a patient with heart failure in a hospital
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the experience group, the home care program was implemented for 6 months. The nurses involved in the study visited patients' homes every two weeks to monitor patients, and telephone follow-ups were performed every three days.
Category
Prevention
2
Description
Control group: In the control group, all steps and measurements were the same except for the home care program. So that the home care program was not implemented for the control group, but the number of times and the number of hospital days were recorded 30, 90 and 180 days before and after the program
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fidan Shabani
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Email
fidannahal@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Majid Maleki
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Email
fidannahal@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular Medical and Research Center
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fidan Shabani
Position
superviser-nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Email
fidannahal@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fidan Shabani
Position
superviser-nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Email
fidannahal@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fidan Shabani
Position
superviser-nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Email
fidannahal@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available