Comparison the effect of home-based education and active care versus usual care on self-care behavior, quality of life, 1year rehospitalization and survival of heart failure patients
To investigate the effect of home-care and education on self-care, quality of life, rate of re-hospitalization and mortality compared to conventional care in patients with chronic heart failure.
Design
Randomization of 128 patients with heart failure to two parallel groups, intrventional and control groups, 64 patients in each group and outcome study
Settings and conduct
The hospitalized patients will be divided in two intervention and control groups. A questionnaire, (self care, demographic, SF-36 questionnaires and drugs) will be completed at the time of discharge for all patients. The intervention group will be educated monthly by a nurse at home up to six month. The control group will receive their usual care. After one year, all patients re-evaluated for the outcomes.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: acute heart failure, resident of Yazd; NYHA class II-IV. Exclusion Criteria: dementia, fatal associated disease such as cancer or dialysis and not acceptance by patients.
Intervention groups
interventional group: Patients with heart failure and Education of self care managment at home every month for 6 months.
Control group: Patients with heart failure and conventional care
Main outcome variables
Primary: rehospitalization and 1-year mortality rate
Secondary: means of self-care and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170522034081N2
Registration date:2019-06-07, 1398/03/17
Registration timing:registered_while_recruiting
Last update:2019-06-07, 1398/03/17
Update count:0
Registration date
2019-06-07, 1398/03/17
Registrant information
Name
mahdieh ghanbari firoozabadi
Name of organization / entity
Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3525 8354
Email address
m.ghanbari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
99.980.000 rials
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of home-based education and active care versus usual care on self-care behavior, quality of life, 1year rehospitalization and survival of heart failure patients
Public title
Comparison the effect of home-based education and active care versus usual care on self-care behavior, quality of life and 1 year re-hospitalization and survival of patients admitted with acute heart failure in Afshar hospital
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
heart failure secondary to ischemic heart disease (IHD) and non-ischemic hear disease (NIH) on the basis of physician's diagnosis and patient's symptoms, and NYHA class II-IV
being a native and resident of Yazd
Exclusion criteria:
dementia or any condition that hinders proper communication with the patient
fatal associated disease that fosters the early death of the patient such as cancer or hemodialysis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. Tool used in randomization is random table is made with computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is blinded for care provider, investigator, outcome assessor, data analyser, data and safety monitoring board.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
shahid sadoughi blv., bahonar sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917945556
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.407
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart disease
Primary outcomes
1
Description
Self care
Timepoint
Before intervention, 3 month, 6 month, 1 year after intervention
Method of measurement
The European 9-item self-care Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention, 3 month, 6 month, 1 year after intervention
Method of measurement
Sf-36 Quality of Life Questionnaire
2
Description
Rehospitalization
Timepoint
3 month, 6 month, 1 year after intervention
Method of measurement
Telephone call
3
Description
Death
Timepoint
3 month, 6 month, 1 year after intervention
Method of measurement
Telephone call
4
Description
6 minuet walk test
Timepoint
6 month, 1 year after intervention
Method of measurement
Doing 6 minuet walk test in cardiac rehabilitation center
Intervention groups
1
Description
Education and care at home
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar hospital
Full name of responsible person
Dr. Mahdieh Ghanbary Firoozabadi
Street address
Afshar hospital, Cardiac Rhabilitation Center, Jomhouri blv.
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 21 3525 8354
Email
mahdieh_ghanbari@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
dr. Amir Houshang Mehrparvar
Street address
Shahid Sadoughi blv., Bahonar sq., Yazd
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3724 0172
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
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
Yazd University of Medical Sciences
Full name of responsible person
Azade sadat Poorhoseini
Position
Nutrition consultant
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Cardiac Rehabilitation Center, Afshar hospital, Yazd
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 8354
Fax
Email
porhoseini90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
dr. Mohamad Hossein Soltani
Position
Heart Failure flow-ship
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Afshar hospital, jomhouri blv, yazd
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3523 1421
Fax
Email
mhsoltani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hakimeh Dadras
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Afshar hospital, jomhouri blv, yazd
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 8354
Fax
Email
dadras.hakimeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be filled in SPSS.
When the data will become available and for how long
2020
To whom data/document is available
Every researchers in this field
Under which criteria data/document could be used
these data is available after getting justification.
From where data/document is obtainable
Mahdieh Ghanbari Firoozabadi, Physician of cardiac rehabilitation center, tel: 0098 353 525 83 54
Email: mahdieh_ghanbari@yahoo.com
What processes are involved for a request to access data/document
After obtaining the license, the Vice-Chancellor of Information is available to the applicant.