Evaluate of empowerment program effect on self care behaviors and readmission of patients with heart failure
Design
Randomized control trial with an empowerment program and outcome assessment
Settings and conduct
In this study, patients referred to the clinic of Masih Daneshvari Hospital in Tehran with heart failure will be identified and after obtaining informed consent, they were randomly assigned to a blocked intervention or control group. Then the level of self-care measures for both groups is evaluated. In this study for the intervention group carried out the empowerment plan includes a curriculum package and a face-to-face training along with telephone follow up but no action is taken in the control group. After 6 months, the level of self care measures and readmission is evaluated for both groups and the groups are compared
Participants/Inclusion and exclusion criteria
Ejection fraction below 40%
Voluntary to participate in research
Age older than 18 years
Patients with heart failure grade 2, 3 or 4 according to American Heart Association criteria and cardiologist diagnosis Reading and writing skills
Having a smartphone and the ability to use it himself or caregiver
Intervention groups
The patient with cardiac failure referred to clinic
Main outcome variables
The rate of self care measures and readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110704006946N2
Registration date:2018-08-07, 1397/05/16
Registration timing:registered_while_recruiting
Last update:2018-08-07, 1397/05/16
Update count:0
Registration date
2018-08-07, 1397/05/16
Registrant information
Name
mansour dianaty
Name of organization / entity
kashan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 36 1557 8645
Email address
dianati_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment program on self-care behaviors and re-admission of patients with heart failure
Public title
"Effect of empowerment program on Self-care behaviors"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ejection fraction< 40%
Inclination to participate in research
Age older than 18 years
Patients with heart failure grade 2, 3 or 4 according to American Heart Association criteria and cardiologist diagnosis
Reading and writing skills
Having a smartphone and the ability to use it himself or caregiver
Exclusion criteria:
Participating simultaneously in another similar study
The presence of hearing and vision problems according to the biography contained in the case and the patient's or family's remarks
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, pezeshk Blvd.
City
Kashan
Province
Isfehan
Postal code
8715985131
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.32
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
150.0
ICD-10 code description
Congestive heart disease
Primary outcomes
1
Description
The score obtained from " Self Care Heart Failure Index" questionnaire and hospital readmission
Timepoint
At beginning of study and 6 month later of that
Method of measurement
Self Care Heart Failure Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study for the intervention group carried out the empowerment plan includes a curriculum package and a face-to-face training along with telephone follow up.
Category
Other
2
Description
Control group: no action is taken in the control group but only evaluating of selfcare in two time.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
sara Rezaei
Street address
Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
19569444
Phone
+98 21 2712 2626
Email
sara.rezaiee63@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
sara rezaie
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715985131
Phone
+98 31 5557 0029
Email
dianati_m@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
sara rezaei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pezeshk st
City
Kashan
Province
Isfehan
Postal code
8715985131
Phone
+98 31 5554 2999
Email
sara.rezaiee63@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
mansour dianaty
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Road kashan university of Medical Sience
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31555431
Email
dianati_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
sara rezaei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 21 7734 9199
Email
sara.rezaiee63@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