Protocol summary

Study aim
The effect of self-care education with teach-back method in both virtual and face-to-face methods on self-esteem of heart failure patients
Design
This randomized clinical trial study with parallel groups will be conducted on 70 patients with heart failure hospitalized in Peymaniyeh and Seyed al-Shohada hospitals in Jahrom. Patients participating in the study will be divided into two groups of face-to-face and virtual training by means of a sealed envelope.
Settings and conduct
Patients with heart failure hospitalized in Peymaniyeh and Seyed al-Shohda hospitals in Jahrom will be included in the study. Patients participating in the study will be divided into two groups of face-to-face and virtual training by means of a sealed envelope.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with heart failure referred to Peymaniyeh and Seyyed al-Shohda Hospitals in Jahrom, who express their consent to participate in the study. Exclusion criteria: includes patients who have attended classes and educational programs in the field of heart failure during the past 6 months.
Intervention groups
Face-to-face training group: The training content of using the self-care training method will be implemented in 4 sessions of 30 minutes in the form of individual face-to-face training during the patient's hospitalization in the ward. Virtual training group: The training content of the use of the self-care training method will be provided using the ITA program by mobile phone.
Main outcome variables
Self-esteem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230219057452N1
Registration date: 2023-07-26, 1402/05/04
Registration timing: registered_while_recruiting

Last update: 2023-07-26, 1402/05/04
Update count: 0
Registration date
2023-07-26, 1402/05/04
Registrant information
Name
Mohammadreza Oliyee jahromy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5427 8565
Email address
rezaolich@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-10-02, 1402/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of self-care education with teach-back method in both virtual and face-to-face methods on self-esteem of heart failure patients in hospitals affiliated to jahrom university of medical science in 1401
Public title
The effect of recursive self-care training in both virtual and face-to-face methods on the self-esteem of hospitalized heart failure patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having minimum literacy to read and write At least 12 months have passed since heart failure The ability to make phone calls and the ability to work with mobile phones and virtual networks Compliance with the training program in the training sessions
Exclusion criteria:
Participation or benefit from other classes and educational programs in the field of heart failure during the last 6 months Mental and psychological disorders based on the patient's file Severe infectious or debilitating illness
Age
From 25 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
The samples will be randomly assigned to groups A (recipients of face-to-face training) and group B (recipients of virtual training) according to two types of cards, A and B, using the method of sealed envelopes.
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
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom, Motahari Boulevard, University of Medical Sciences
City
Jahram
Province
Fars
Postal code
7167758256IR.JUMS.RE
Approval date
2023-02-07, 1401/11/18
Ethics committee reference number
IR.JUMS.REC.1401.118

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Self-esteem
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Rosenberg self-esteem questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: The educational content of using the self-care training method will be implemented in 4 sessions of 30 minutes in the form of individual face-to-face training during the patient's hospitalization in the ward.
Category
Lifestyle

2

Description
Intervention group 2: The educational content of the use of the self-care training method will be provided using the ITA program by mobile phone.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Peymaniye Hospital, Jahrom city
Full name of responsible person
Mohammad Reza Olyaei
Street address
Shahid Motahari Boulevard, Peymaniye Hospital, Jahrom
City
Jahram
Province
Fars
Postal code
71677251542
Phone
+98 919 199 4886
Email
rezaolich@gmail.com

2

Recruitment center
Name of recruitment center
Seyed al-Shohda Jahrom Hospital
Full name of responsible person
Mohammad Reza Olyaei
Street address
Jahrom, Shahid Motahari Blvd., Seyed al-Shohada Hospital
City
Jahram
Province
Fars
Postal code
71677251542
Phone
+98 919 199 4886
Email
rezaolich@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavous Solhjoo
Street address
Jahrom, Shahid Motahari Blvd., Jahrom University of Medical Sciences, Research Assistant
City
Jahram
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
solhjok@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Mohammad Reza Olyaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahram
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
rezaolich@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Ali Dehghani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahram
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
ali.dehghani2000@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohammad Reza Olyaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahram
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
rezaolich@gmail.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
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