Protocol summary

Study aim
Effect of self-care education with Teach Back method on the knowledge, Practice , reducing hospital readmission and Quality of Life in heart failure patients
Design
The Altman Nemogram method was used to determine the sample size. The sample size was 32 in each group, accounting for 10% of the sample loss in each group, 35 individuals in each group and a total of 70 in each group. After determining the sample size (70 samples), randomly (lottery) samples were placed in two 35 individuals in the intervention and control groups. (Random allocation) (first person in the experimental group and the second one in the control group)
Settings and conduct
The samples are placed in two groups of test and control based on the criteria and individual characteristics. Patients with heart failure admitted to Baqiyatallah Hospital.
Participants/Inclusion and exclusion criteria
Age 45 to 85 years, Patients who have been diagnosed for at least six months, The rate of discharge less than 45%, With a minimum reading and writing literacy, full of alertness and fluent in Persian. Diseases that alter the patient's quality of life and any reason that may lead to a violation of entry criteria during the study.
Intervention groups
At least 3 sessions of 30 to 45 minutes will be taught on heart failure issues and self-care as Teach Back.
Main outcome variables
Improvement of knowledge, performance, reduction of referral, quality of life for patients with heart failure, ability to enter the necessary and current care for patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180930041178N1
Registration date: 2018-12-22, 1397/10/01
Registration timing: registered_while_recruiting

Last update: 2018-12-22, 1397/10/01
Update count: 0
Registration date
2018-12-22, 1397/10/01
Registrant information
Name
Masoud Sirati nir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 2139
Email address
m.sirati@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-care education with Teach Back method on the knowledge, Practice , reducing hospital readmission and Quality of Life in heart failure patients
Public title
Effect of self-care education with Teach Back method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Passed at least six months of diagnosis Drainage fraction less than 45% Reading and writing literacy Complete Consciousness Fluent in Persian
Exclusion criteria:
Age
From 45 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the sample size (70 samples), randomly (lottery) samples were allocated in two 35 individuals in the intervention and control groups. (Random allocation) (first person in the intervention group and the second one in the control group)
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
The Ethics Committee of the Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Molasadra st, Vanak sq
City
Tehran
Province
Tehran
Postal code
14359195371
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.BMSU.REC.1396.268

Health conditions studied

1

Description of health condition studied
Heart Failure
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-care education with Teach Back method
Timepoint
Measurement at three points in the beginning of the study and 2 months and 4 months after the start of the study
Method of measurement
Questionnaires on quality of life and self-care knowledge

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Training on heart failure issues and self care based on Teach Back at least 3 sessions 30 to 45 minutes
Category
Rehabilitation

2

Description
Control group: The control group is placed under the current training of the hospital. After the training, the self-care knowledge questionnaire will be completed and the amount of the changes will be determined.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Hamidreza Taghipour
Street address
Baqiyatallah Hospital, Molasadra st, Vanak Sq
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
baq@bmsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Jalali
Street address
Nosrat alley, Sheykhbahaye st, Molasadra st, Vanak sq
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2408
Email
EPRC_Research@bmsu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Masoud Sirati nir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8248 3505
Fax
Email
masoudsirati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Masoud Sirati nir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Molla-sadra St, Vanak Squar , Baqiyatallah University of Medical Sciences, Behavioral Sciences Research Center
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 2139
Fax
Email
masoudsirati@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Masoud Sirati nir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Molla-sadra St, Vanak Squar , Baqiyatallah University of Medical Sciences, Behavioral Sciences Research Center
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 2139
Fax
Email
masoudsirati@gmail.com

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 on the level of knowledge, performance, quality of life, personal information and other data obtained from the information questionnaire.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Respecting copyright
From where data/document is obtainable
Research ِDepartment of the Baqiyatallah University of Medical Sciences
What processes are involved for a request to access data/document
Submit a written request and confirmation of the institution
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