Comparison of the impact of teach-back and pictorial education approaches on self-care behaviors for heart failure patients admitted in Farshchian hospital of Hamadan in 2018.
Comparation the effect of two teach-back and pictorial teaching methods on self-care behaviors of patients with heart failure.
Design
Randomized clinical trial with three groups, parallel group
Settings and conduct
The present study is conducted on 138 patients with heart failure referring to Farshchian hospital of Hamadan in three groups (two interventions and one control). In two intervention groups, training will be conducted by two methods of pictorial and teach-back on heart failure, nutrition, and drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient with heart failure for at least 6 months, Age between 40-70 years, Hospitalization in the heart ward for at least three days
Exclusion criteria: Not attending in training sessions more than one meeting, Unwillingness to continue participating in the study
Intervention groups
In intervention group1:Training was conducted in teach-back method on the diet, physical activity and drug use will be presented during three sessions in three consecutive days and each session for 20 minutes.
In intervention group2: Training was conducted with posters and photos (pictorial method) on diet, physical activity and drug use during three sessions for three consecutive days and each session for 20 minutes.
In the control group: No special action will be taken.
Main outcome variables
Compliance with self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N16
Registration date:2018-10-12, 1397/07/20
Registration timing:registered_while_recruiting
Last update:2018-10-12, 1397/07/20
Update count:0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the impact of teach-back and pictorial education approaches on self-care behaviors for heart failure patients admitted in Farshchian hospital of Hamadan in 2018.
Public title
Comparison of the impact of teach-back and pictorial education approaches
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with heart failure for at least 6 months
Age between 40 to 70 years
Being admitted to the research environment for at least three days
Exclusion criteria:
Not attending more than one session in training classes
Unwillingness to continue participating in the study
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
138
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the patients were registered according to the sample size (138) according to the entry criteria, and using the blocking method (using a three-block method, three letters A, B and C with different permutations we place blocks in blocks and randomly select 46 blocks and assign each block to 3 people) will be assigned to three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.403
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
Compliance with self-care behaviors
Timepoint
Before and after intervention
Method of measurement
Self-care behaviors compliance questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The tutorial will be run using the teach-back method. Educational content will be taught to the patient by a face-to-face researcher in plain language without the use of medical terminology. The patient is then asked to express the educational content in his / her own language. If the patient does not understand correctly, the content will be re-educated
Category
Lifestyle
2
Description
Intervention group2: Face-to-face training will be done with simple pictures, posters, and drug labels to remind of taking medications .
Category
Other
3
Description
Control group: Face-to-face training will be done at the time of admission in the ward.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mahnaz Khatiban
Street address
Shahid Fahmideh St., Farshchian Hospital, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khatiban@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khatiban@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khatiban@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Aghamohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Maryam.am44201847@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