Protocol summary

Summary
The purpose of this study is to determine the effect of Educative Intervention on Knowledge and Self Efficacy in Patients Undergoing Hemodialysis about Blood Pressure Control, The main inclusion criteria: having a history of hemodialysis for at least 6 months; at least 4 weeks systolic blood pressure over 140 mmhg before the hemodialysis or diastolic blood pressure over 90 mmhg, The main exclusion criteria: Receiving a kidney transplant, incurable disease (cancer, AIDS, ...). the research community, including patients undergoing hemodialysis with high blood pressure for hemodialysis are admitted to Sina Hospital in Tabriz, The number of samples in each group will be considered 30 people. Study is Randomized, non-blinded. Firstly, the knowledge and self-efficacy of all patients will be assessed by the questionnaires. Then for the intervention group, individual training runs by the researcher, which include: the importance of the hemodialysis sessions, fluid and salt intake limits, how to control blood pressure, blood pressure effects, the importance of drug consumption in the 2 meeting of 20 to 30 minutes in 2 consecutive turns at the bedside during the early hours of the hemodialysis because of favorability of the patient and in conclusion, educational pamphlets will be delivered to the patients. Then once a week they will be pursued by the researcher. The control group will receive training routine. Knowledge and self-efficacy will be re-evaluated after 12 weeks for determine The effect of Educative Intervention on Knowledge and Self Efficacy in Patients Undergoing Hemodialysis about Blood Pressure Control.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014071618503N1
Registration date: 2014-12-19, 1393/09/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Masoumeh Baghdeli Abotalebi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1666 4235
Email address
baghdeli90@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educative interventions on knowledge and self efficacy of blood pressure control in Patients undergoing hemodialysis: A Randomized Clinical Trial
Public title
The effect of education on blood pressure control in patients undergoing hemodialysis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Over 18 years of age, reading and writing literacy, having a history of hemodialysis for at least 6 months; at least 4 weeks systolic blood pressure over 140 mmhg before the hemodialysis or diastolic blood pressure over 90 mmhg; awareness of the time, place, person, not having a mental disorder (diagnosed according to the patient's record); lack of formal training from other sources during the study, lack of physical limitations in self-care Exclusion criteria: Receiving a kidney transplant, incurable disease (cancer, AIDS, ...); unwillingness to continue reading
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
9115140301

Health conditions studied

1

Description of health condition studied
Blood pressure in hemodialysis patients
ICD-10 code
N18.5 ,I12
ICD-10 code description
High blood pressure,Dependence on renal dialysis

Primary outcomes

1

Description
knowledge
Timepoint
At baseline and after 12 weeks
Method of measurement
Questionnaire

2

Description
self efficacy
Timepoint
At baseline and after 12 weeks
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Blood pressure
Timepoint
At baseline and after 12 weeks
Method of measurement
Blood pressure device

2

Description
before dialysis weight
Timepoint
At baseline and after 12 weeks
Method of measurement
scale

Intervention groups

1

Description
For the intervention group, individual training runs by the researcher, which include: the importance of the hemodialysis sessions, fluid and salt intake limits, how to control blood pressure, blood pressure effects, the importance of drug consumption in the 2 meeting of 20 to 30 minutes in 2 consecutive turns at the bedside during the early hours of the hemodialysis because of favorability of the patient and in conclusion, educational pamphlets will be delivered to the patients. Then once a week they will be pursued by the researcher.
Category
Behavior

2

Description
The control group will receive routine training
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Masoumeh Baghdeli Abotalebi
Street address
Iran, Tabriz Sina Hospital, unit Hemodialysis
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh Baghdeli Abotalebi
Street address
Tabriz University of Medical Sciences, Faculty of Nursing
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh Baghdeli Abotalebi
Position
Master of nursing sience student
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
00984114797069
Phone
+98 41 1479 7069
Fax
Email
baghdeli90@gmail.com parvank@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh Baghdeli Abotalebi
Position
Master of nursing sience student
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
00984114796770
Phone
+98 41 1479 6770
Fax
Email
baghdeli90@gmail.com parvank@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh Baghdeli Abotalebi
Position
Master of nursing sience student
Other areas of specialty/work
Street address
Tabriz, valie amr street, 24 alley, nom:149
City
Tabriz
Postal code
5156675675
Phone
+98 41 3666 4235
Fax
Email
baghdeli90@gmail.com parvank@yahoo.com
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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