Comparison the effect of self-care education by teach back and multimedia method on the level of self-care, quality of life and readmission of patients with advanced heart failure
Comparison the effect of self-care education by teach back and multimedia method on the level of self-care, quality of life and readmission of patients with advanced heart failure
Design
Randomized clinical trial, continuous sampling without blinding, 120 patients, by random block method with size 6
Settings and conduct
120 patients with advanced heart failure in five CCU departments of Shahid Rajaei Cardiovascular Center in 1402 were randomly assigned to three groups of 40 people (teach back and multimedia and control group) by randomization using random blocks of size 6. Training with the same content will be carried out in two intervention groups in the evening of two consecutive days for one hour each time at the patient's bedside. Demographic questionnaire, European self-care questionnaires in heart failure and quality of life of Minnesota heart failure patients before the intervention in person and in writing, by the patient and one month later by the researcher and by phone, and the readmission of the patient (and the number of times) to The cause of advanced heart failure is also investigated. The analysis is done by SPSS24 software and statistical tests.
Participants/Inclusion and exclusion criteria
Admission: age 18 to 65 years - suffering from advanced heart failure according to the diagnosis of a cardiologist and EF less than 30% - no history of mental disorders based on the patient's self-report - no speech, hearing, cognitive and memory deficits
Exit: the patient's unwillingness to continue participating in any stage of the research - the inability to communicate by phone during the follow-up period - the patient's death
Intervention groups
Self-care training in groups:teach back - multimedia - control
Main outcome variables
Self-care score and quality of life score one month after the intervention, readmission one month after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230808059079N1
Registration date:2023-08-19, 1402/05/28
Registration timing:prospective
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
mahsa satari gholami
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 4895
Email address
mahsa.satari.gh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-21, 1402/06/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of self-care education by teach back and multimedia method on the level of self-care, quality of life and readmission of patients with advanced heart failure
Public title
Self-care training in patients with advanced heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Patient alertness
Minimum literacy
Having advanced heart failure according to the diagnosis of a cardiologist and EF less than 30%
Not having a history of mental disorders based on the patient's self-report
Not having an education in the department of medical sciences
Not having speech, hearing, cognitive and memory defects
Having a smart mobile phone and being able to use it
Exclusion criteria:
The patient's unwillingness to continue participating in any stage of the research
It is not possible to communicate by phone during the follow-up period
death of the patient
Age
From 18 years old to 65 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
According to the inclusion criteria, patients with advanced heart failure will be divided into three groups of 40 people based on randomization using random blocks of size 6, and the patients will be allocated to each of the two teachback and multimedia intervention groups and A control group is performed. In this way, 20 blocks of 6 by computer program
CREATE A RANDOMISATION LIST will be created. (https://www.sealedenvelope.com/simple-randomiser/v1/lists) and then the samples will be placed in one of the groups in the order provided by this program (an example of a sequence of random numbers in each It consists of 6 blocks: AABBCC, ABCABC, ABACBC, ACBCAB, etc.).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Cardiovascular Medical Research Training Center
Street address
NO. 120, pars Building, marvdasht street, moalem street, shariati street, tehran
City
Tehran
Province
Tehran
Postal code
1639766669
Approval date
2023-08-05, 1402/05/14
Ethics committee reference number
IR.RHC.REC.1402.043
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
2
Description of health condition studied
Left ventricular failure
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure
3
Description of health condition studied
Systolic (congestive) heart failure
ICD-10 code
I50.2
ICD-10 code description
Systolic (congestive) heart failure
4
Description of health condition studied
Heart failure, unspecified
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
5
Description of health condition studied
Diastolic (congestive) heart failure
ICD-10 code
I50.3
ICD-10 code description
Diastolic (congestive) heart failure
6
Description of health condition studied
Combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10 code
I50.4
ICD-10 code description
Combined systolic (congestive) and diastolic (congestive) heart failure
7
Description of health condition studied
Acute systolic (congestive) heart failure
ICD-10 code
I50.21
ICD-10 code description
Acute systolic (congestive) heart failure
8
Description of health condition studied
Chronic systolic (congestive) heart failure
ICD-10 code
I50.22
ICD-10 code description
Chronic systolic (congestive) heart failure
9
Description of health condition studied
Acute diastolic (congestive) heart failure
ICD-10 code
I50.31
ICD-10 code description
Acute diastolic (congestive) heart failure
10
Description of health condition studied
Chronic diastolic (congestive) heart failure
ICD-10 code
I50.32
ICD-10 code description
Chronic diastolic (congestive) heart failure
11
Description of health condition studied
Acute on chronic diastolic (congestive) heart failure
ICD-10 code
I50.33
ICD-10 code description
Acute on chronic diastolic (congestive) heart failure
Primary outcomes
1
Description
Self-care score
Timepoint
Before the start of the intervention, 30 days after the intervention
Method of measurement
European questionnaire of self-care behavior in heart failure
2
Description
Quality of life score
Timepoint
Before the start of the intervention, 30 days after the intervention
Method of measurement
Questionnaire of the quality of life of Minnesota heart failure patients
3
Description
Readmission due to heart failure (Number of readmissions)
Timepoint
One month after the patient's discharge
Method of measurement
Verbal interview with the patient/check through the hospital's HIS system
Secondary outcomes
1
Description
Not available
Timepoint
Not available
Method of measurement
Not available
Intervention groups
1
Description
The first intervention group: Self-care training in advanced heart failure patients using teach back method, 40 of these patients were trained by the researcher in the evening of two consecutive days for one hour each time in the ward where the patient is hospitalized and at the patient's bed during hospitalization. And they will receive face-to-face, interactive, question and answer, repetition and practice. After two one-hour training sessions, a pamphlet with the same content taught to the patients will be presented. The patient will be followed up by the researcher for one month after discharge, so that the researcher will call the patient once a week and review the educational content by phone and based on teach back . Self-care education includes the description of heart function, definition of heart failure, The causes and symptoms of this disease and its treatment control, drug treatment tips, diet tips, fluid intake, daily note of fluid intake and daily urine volume, how to perform physical activity, daily weighing, training to avoid smoking and alcohol consumption, annual injection Flu vaccine and other health and safety tips.
Category
Lifestyle
2
Description
The second intervention group: self-care training in advanced heart failure patients by multimedia method, 40 of these patients, training by the researcher in the evening of two consecutive days for one hour each time in the ward where the patient is hospitalized and at the patient's bedside. They will receive the prepared multimedia (film, image, audio, text, moving images, etc.) individually with the same conditions by laptop, and at the end, if the patients have any questions, they will be answered. The training content will be sent to this group in the form of a link by SMS, and the patients will receive the same multimedia training content by opening this link. This link includes the content of the self-care program: the nature of heart failure disease, its causes and manifestations, exercise and physical activity, drugs, diet, safety and health tips and lifestyle, which are presented in two sessions at the patient's bedside in the form of video, photos, audio, The text, moving images will be played, and this link will be made with the help of respected professors and advisors. After the last training session, the patient will be monitored for one month and the researcher will follow up once a week to review the multimedia content through the link sent.
Category
Lifestyle
3
Description
Control group: 40 patients with advanced heart failure will receive the department's routine training including diet, activity, bathing, daily weight control, how to take medications in the form of a two-page training booklet by the department's nurses.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
fidan shabani
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave , Niayesh Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
fidannahal@yahoo.com
Web page address
http://www.rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
fidan shabani
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
fidannahal@yahoo.com
Web page address
http://www.rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Rajaie Cardiovascular, Medical & Research Center
Proportion provided by this source
50
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
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
mahsa satari gholami
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center , Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
mahsa.satari.gh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
fiadan shabani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center , Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
fidannahal@yahoo.com
Web page address
http://www.rhc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
mahsa satari gholami
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center , Valiasr Ave Niayesh Intersection ,Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 7756 4895
Email
mahsa.satari.gh@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
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For the use of researchers and people who decide to help correct the lifestyle of people with advanced heart failure.
From where data/document is obtainable
E-mail: mahsa.satari.gh@gmail.com
What processes are involved for a request to access data/document
Finally, the documents will be sent within two weeks.