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comparison the effect of teach back and media education on self- care and social support of patients heart failure and mental health of carers

Protocol summary

Study aim
Comparison of the effect of teach back and media Education on self-care and social support of patients heart failure and mental health carers
Design
3arm parallel group randomised trial with Random number table
Settings and conduct
Theteachback training method provides the necessary training on the nature of the disease, signs and symptoms of illness, treatment, weight control, diet and medication, physical and sexual activity, and post-treatment follow-up. The method of teaching the media provides the same training through CD. Combined training, training the same topics through CD and teach back will be taught
Participants/Inclusion and exclusion criteria
For patients :age more than 18; heart failure; no experience in attendance; ability to read and write and understand persian; hearing and defect Cognitive and memory, being alert, not having chronic disease ,have not mental illness, being telephone and having a DVD player.not be a member of the healthcare team, unwillingness to continue the study, not contactable by telephone and cannot apply attendance , , the stressful event during follow-up and death. For caregivers: adults, living in the same household as the patient with HF,ability to reading and writing, ability and willingness to take care of the patient, owning a cellular DVD، not be a member of the healthcare team, not have mental illness and disability.
Intervention groups
case group teach back:The patient and his caregiver are trained in a teach back based manner . The media intervention group: the patient and his caretaker, are under media training. Combined intervention group: patient and carer are combined
Main outcome variables
Self-care improvement, social support of patients and mental health care providers using Self-care questionnaire, perceived social support and Goldberg's mental health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151004024342N5
Registration date: 2018-09-14, 1397/06/23
Registration timing: registered_while_recruiting

Last update: 2018-09-14, 1397/06/23
Update count: 0
Registration date
2018-09-14, 1397/06/23
Registrant information
Name
Vida Shafipour
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
v.shafipour@mazuma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effect of teach back and media education on self- care and social support of patients heart failure and mental health of carers
Public title
"The effect of education on self -care of patients and mental health carers"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: age more than18،Heart failure according to echo-cardiologist and cardiologist،no experience in attendance, ability to read and write and understand persian, hearing and defect Cognitive and memory( Alzheimer) , being alert,not having Chronic disease( Cancer ,COPD, CRF , Cirrhosis, Thyroid), have not mental illness, being telephone and having a DVD player. Inclusion caregivers:adults،Living in the same household as the patient withe HF, ability to reading and writing , ability and willingness to take care of the patient Owning a cellular DVD ,
Exclusion criteria:
Exclusion criteria: not be a member of the healthcare team, unwillingness to continue the study, not contactable by telephone and cannot apply attendance , the stressful event during follow-up and death Exclusion caregivers: not be a member of the healthcare team , not have mental illness and disability
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment based on random number table
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 mazandaran University of Medical Sciences
Street address
Moalem Square
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
IR.MAZUMS.REC.1397.1151

Health conditions studied

1

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

Primary outcomes

1

Description
Self- care
Timepoint
Before training, before discharge, weeks 4 and 8 after discharge
Method of measurement
European Heart Self-care Behavioure Scale(EHScBS)

2

Description
Social support
Timepoint
Before training, before discharge, weeks 4 and 8 after discharge
Method of measurement
Multi-dimensional questionnaire of perceived social support

3

Description
Mental health
Timepoint
Before training, before discharge, weeks 4 and 8 after discharge
Method of measurement
General Health Questionaire( G.H.Q)

Secondary outcomes

1

Description
Self care
Timepoint
Before training, before discharge, weeks 4 and 8 after discharge
Method of measurement
European Heart Self-care Behavioure Scale(EHScBS)

2

Description
Social Support
Timepoint
Before training, before discharge, weeks 4 and 8 after discharge
Method of measurement
Multi-dimensional questionnaire of perceived social support

3

Description
Mental Health
Timepoint
Before training, before discharge, weeks 4 and 8 after discharge
Method of measurement
General Health Questionaire (G.H.Q)

Intervention groups

1

Description
Intervention group 1: group teach back (patient-caregiver) post-needle training group, on the first day after admission to the waiting room, a teach back approach was developed in four areas (the nature of the disease, signs and symptoms, treatment, diet and medication, physical activity, and Sexual and follow-up after discharge will be done for 20-30 minutes within 4 consecutive days, if the patient does not want to be trained, the training will be postponed until the end of the session for 20-15 minutes by check list of educational content will be asked from the patient and his caregiver, if necessary, the training material will be repeated
Category
Behavior

2

Description
Intervention group 2: In the media group (patient-caregiver), after the needle-setting, the first day after admission to 4 educational fields (the nature of the disease, signs and symptoms, treatment, diet and medication, physical activity and sexuality, and post-clearance follow-up) 4 consecutive days for 20-30 minutes by educational CD and DVD player in the waiting room, and the training will be sent to the carers through the virtual program (telegram). At the end of each training session A period of 20-15 minutes will be used to check the patient-caregiver's checklist, if necessary, the content will be repeated
Category
Behavior

3

Description
Intervention group3: After the patient's need-caregiver, take care of the patient from the first day after admission for 4 consecutive days in 4 fields of training for 20-30 minutes in the waiting room, through teach back training and electronic file (educational CD). Became At the end of each session, the patient-caregiver will be asked for a 20-15 minute checklist. If necessary, the content will be repeated again
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
fatemeh Zahra Hospital
Full name of responsible person
Dr. Vida Shafi Pour
Street address
Artesh Boulvar T shahrdari square
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
vidashafipour@yahoo.com

2

Recruitment center
Name of recruitment center
بیمارستان امام خمینی ( ره) نور
Full name of responsible person
Dr. Vida Shafi Pour
Street address
Imam Khomeini Street
City
noor
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
vidashafipour@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Vida Shafi Pour
Street address
Amir Mazandarani Blvd. Alley of Wesal Shirazi
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
vidashafipour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Vida Shafi Pour
Position
PhDEducation Nursing - faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery ،Vesel Shirazi Street , Amir Mazandarani Boulevar
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
v.shafipour@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Vida Shafi Pour
Position
phd.Education Nursing- faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery , VesalShirazi Street , Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
vhdashafipour@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Karami Salahodin kolah
Position
Master Critical Care Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Salahodin kolah - Shahid Kayhan Turks Street
City
nowshar
Province
Mazandaran
Postal code
4654113667
Phone
+98 11 5217 3194
Email
msalahodin_57@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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