The goal of this study is determine the effectiveness of the educational intervention based on self-efficacy on promoting self-care in hemodialysis patients. This is a quasi-experimental study that conducts in 2016. The research population consists of 70 hemodialysis patients referring to dialysis unit of Kamkar-Arabnia hospital in Qom city and they are randomly allocated to intervention (n=35) and control (n=35) groups. This study is performed in single center and is not blinded. Inclusion criteria includes age between 20-60 years; be able to read and write; lack of the mental disorders; having suitable physical condition and willingness to participate in the study, exclusion criteria includes Kidney transplantation, migration and patient death during the intervention. After completing informed consent by patients, data are collected from the samples of both groups by 3 questionnaires and through organized interview. The educational program based on self-efficacy theory is performed for the experimental group in 2 one-hour sessions. The issue of this sessions is self-care in dimensions: nutrition and diet, care of fistula and etc. Educational sessions are performed through face-to-face, lecture, question-and-answer and group discussion. Training materials are pamphlet and booklet. Both groups are followed for 3 months after the intervention then will be performed a post-test. No educational intervention is done on control group. The primary outcome of this study is self-efficacy and secondary outcome is self-care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071628948N1
Registration date:2016-09-24, 1395/07/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-24, 1395/07/03
Registrant information
Name
Tahereh Ramezani
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3885 8566
Email address
t_ramezani533@yahoo.com
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2016-09-17, 1395/06/27
Expected recruitment end date
2016-12-17, 1395/09/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of the educational intervention based on self-efficacy on promoting self-care in hemodialysis patients
Public title
The impact of education on self-care hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
(Inclusion criteria: age between 20-60 years; be able to read and write and capable of listening, speaking, and consciousness to answer questions; having hemodialysis sessions 3 times per week for 3-4 hours; lack of the physical chronic disorders such as heart, respiratory, liver debilitating diseases; lack of the mental disorders such as severe depression and hospitalization in a psychiatric hospital (according to medical records); having suitable physical conditions and willingness to cooperate in the study; be independent to perform self-care activities (such as walking and eating without help))
(Exclusion criteria: people who are not able to cooperate and give information; Kidney transplantation, migration and patient death during the intervention)
Age
From 20 years old to 60 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
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 Qom University of Medical Sciences
Strategies Used by People to Promote Health questionnaire
Secondary outcomes
1
Description
Self-care
Timepoint
Before, 3 months after intervention
Method of measurement
Researcher-made questionnaire of Self-care
Intervention groups
1
Description
Intervention Group: After completing informed consent by patients, data are collected from the samples of experimental group by 3 questionnairs and through organized interview. Then educatinal content is developed and educational program based on self-efficacy theory is performed for the experimental group in 2 one-hour sessions. The issue of this sessions is self-care in six dimensions: nutrition and diet, care of fistula, control of fluids and electrolytes intake, care of skin, exercise and physical activity and mental health. Educational sessions are performed through face-to-face, lecture, question-and-answer and group discussion. Training materials are pamphlet and booklet. Thisl group are followed for 3 months after the intervention then will be performed a post.
Category
Lifestyle
2
Description
Control group: No educational intervention is done on control group and they are received only usual care. Data are collected from the samples of control group through organized interview before and 3 months after the intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis unit of Kamkar-Arabnia hospital
Full name of responsible person
Fereydoun Mashhadi
Street address
Dialysis unit, Kamkar-Arabnia hospital, 19 Day street, Qom, Iran
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Educational Deputy Qom University of Medical Sciences
Full name of responsible person
Dr Hasan Adeli
Street address
Iran, Qom, Saheli street, Qom University of Medical Sciences, 2nd floor
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Educational Deputy Qom 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
Faculty of Public Health, Qom University of Medical Sciences
Full name of responsible person
Tahereh Ramezani
Position
MSc Student in Health Education and Health Promotion
Other areas of specialty/work
Street address
Faculty of Public Health, Ruhollah Square, Moallem Street, Qom, Iran
City
Qom
Postal code
Phone
+98 25 3783 3595
Fax
+98 25 3783 3595
Email
t_ramezani533@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center of studies and Development of Medical Education