Protocol summary

Summary
This study was conducted to determine the effect of education based on teach back method on self efficacy and self-care in patients with heart failure.62 hospitalized patients with heart failure in Imam Reza and Ghaem hospitals in Mashhad(1393) allocated into experimental and control groups by non-randomly convenient method. Subjects in the experimental group individually received 3-4 days self-care education based on teach back method and control group received usual self-care education. Inclusion criteria were age 18 and older, diagnosis of heart failure via cardiologist and the symptoms and diagnostic tests, the ability to speak and understand the language of persian, have at least literacy; no Previous participate in training programs; No problems with speech, hearing, and cognitive and memory; sober; Lack ofsevere chronic disease (such as thyroid disease, cancer, obstructive pulmonary disease, asthma, kidney and liver failure and limitation of motion); Lack of recognized psychological disorders (such as depression) and not having history of hospitalization due to mental illness. Exclusion criteria at baseline and during the study were: The patient's treatment team member, Unwillingness to continue the cooperation in each of the stages of research, The impossibility of communicating by phone or visit the patient, Creating severe stressful events during follow-up, death of patient. Self-care was measured using European Heart Failure Self-care Behavioure questionnaire(EHFScB) and Self efficacy was measured using cardiac self efficacy questionnaire before and one month after discharge.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070423053N1
Registration date: 2015-07-24, 1394/05/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Zakieh Reihani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1513
Email address
reihaniz2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of education based on teach back method on self-efficacy and self care in patients with heart failure
Public title
Education of patients with heart failure based on teach back method
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria were age 18 and older, diagnosis of heart failure via cardiologist and the symptoms and diagnostic tests, the ability to speak and understand the language of persian, have at least literacy; no Previous participate in training programs; No problems with speech, hearing, and cognitive and memory; sober; Lack ofsevere chronic disease (such as thyroid disease, cancer, obstructive pulmonary disease, asthma, kidney and liver failure and limitation of motion); Lack of recognized psychological disorders (such as depression) and not having history of hospitalization due to mental illness. Exclusion criteria at baseline and during the study were: The patient's treatment team member, Unwillingness to continue the cooperation in each of the stages of research, The impossibility of communicating by phone or visit the patient, Creating severe stressful events during follow-up, death of patient.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery
City
Mashhad
Postal code
9177899191
Approval date
2014-11-11, 1393/08/20
Ethics committee reference number
Research/930559/1/227

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 efficacy
Timepoint
Before and one month after discharge
Method of measurement
Cardiac self efficacy questionnaire

2

Description
Self care
Timepoint
Before and one month after discharge
Method of measurement
European Heart Failure Self-care Behavioure questionnaire(EHFScB)

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: Self-care education based on teach back method
Category
Other

2

Description
Control group: Usual self-care education
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mrs ghyasi
Street address
Imam Reza hospital
City
Mashhad

2

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Mr rahmanian
Street address
Ghaem hospital
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences Research and Technology
Full name of responsible person
Tafaghodi doctor
Street address
Mashhad University of Medical Sciences Research and Technology
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zakieh Reihani
Position
MSc Student in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3879 5031
Fax
Email
Reihaniz2@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zakieh Reihani
Position
MSc Student in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3879 5031
Fax
Email
Reihaniz2@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zakieh Reihani
Position
MSc Student in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3879 5031
Fax
Email
Reihaniz2@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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