Implementation and Evaluation of Heart Failure Patients Discharge Plan
Design
The present study is an interventional, before and after study. The discharge plan is implemented for heart failure patients and the variables are compared before and after the study.The sample size was 26 patients.
Settings and conduct
This study is conducted in Shahid Rajaie Cardiovascular Medical and Research Center for 3 months. The discharge plan will be implemented for patients who have criteria for entering the study. The questionnaires are completed and compared before the program starts and 3 months after its implementation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Patient with heart failure
2) aged 18 or over.
3) live in Tehran.
4) Satisfaction to participate in the study.
5) Have a history of admission more than 1 time within the past 6 months
Exclusion criteria:
1) The patient has undergone cardiac surgery for the last 8 weeks
2) myocardial infarction In the last 4 weeks
3) cardiogenic shock In the last 4 weeks
Intervention groups
This study is part of an action research study. A discharge plan designed for patients with heart failure will be implemented and evaluated.
Main outcome variables
Self-care behavior; quality of life; depression; psychological burden of care; number of admissions; number of admission days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190205042636N1
Registration date:2019-04-29, 1398/02/09
Registration timing:registered_while_recruiting
Last update:2019-04-29, 1398/02/09
Update count:0
Registration date
2019-04-29, 1398/02/09
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
2019-02-19, 1397/11/30
Expected recruitment end date
2019-05-19, 1398/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementation and Evaluation of Heart Failure Patients Discharge Plan
Public title
Implementation and Evaluation of Heart Failure Patients Discharge Plan
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
heart failure patients
age 18 or older
living in Tehran
having the consent to participate in the study
hospitalization more than one during the last six months
Exclusion criteria:
The patient has undergone cardiac surgery for the last 8 weeks
myocardial infarction In the last 4 weeks
cardiogenic shock In the last 4 weeks
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Social Welfare and Rehabilitation Sciences
Street address
Kudakyar, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
IR.USWR.REC.1395.89
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
self-care behavior
Timepoint
Before the start of the discharge plan and 3 months after the discharge plan
Method of measurement
European Heart Failure Self-care Behaviour scale
2
Description
Quality of life
Timepoint
Before the start of the discharge plan and 3 months after the discharge plan
Method of measurement
The Minnesota Living with Heart Failure Questionnaire
3
Description
Depression
Timepoint
Before the start of the discharge plan and 3 months after the discharge plan
Method of measurement
Cardiac Depression Scale
4
Description
psychological burden of care
Timepoint
Before the start of the discharge plan and 3 months after the discharge plan
Method of measurement
Zarit Burden Interview
5
Description
number of hospitalization
Timepoint
Before the start of the discharge plan, 1 month and 3 months after the implementation of discharge plan
Method of measurement
Registration form for the hospitalization of a patient with heart failure in a hospital
6
Description
hospital days
Timepoint
Before the start of the discharge plan, 1 month and 3 months after the implementation of discharge plan
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: The study is an interventional type before and after. For patients enrolled in the study, the discharge plan includes three areas: patient empowerment, home visit after discharge, and post-discharge telephone follow-up implemented for three months, and the outcome variables are compared before and after the implementation of the program.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fidan Shabani
Street address
Valiasr, next to Mellat Park, Shahid Rajaie Cardiovascular Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3244
Email
fidannahal@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Farahnaz Mohammadi Shahboulaghi
Street address
Kudakyar, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
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
University of social welfare and rehabilitation sciences
Proportion provided by this source
1
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
2
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fidan Shabani
Street address
Kudakyar, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
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
University of social welfare and rehabilitation sciences
Proportion provided by this source
99
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fidan Shabani
Position
nurse
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kudakyar, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
fidannahal@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Farahnaz Mohammadi Shahboulaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Kudakyar, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
mohammadifarahnaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fidan Shabani
Position
nurse
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kudakyar, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
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
Not applicable
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