Determining the effect of an educational program based on the understanding of illness on the self-management of hemodialysis patients: a randomized trial study.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized on 62 patients with hypertension in the elderly with a one-month follow-up.
Settings and conduct
The present study will be conducted on hemodialysis patients referred to the hemodialysis center of Imam Reza Medical Education Center (AS) in Larestan.
Participants/Inclusion and exclusion criteria
Patients must be 18 years old or older.
be treated with hemodialysis for at least 3 months.
Have at least two hemodialysis sessions per week.
Having independence in daily activities (walking, eating, etc.)
Able to cooperate to complete the questionnaire and carry out the intervention
Exclusion criteria:
Patients with kidney transplant experience
Unwillingness to participate in the study
Occurrence of serious physical and mental illnesses during the intervention
Participation in similar educational and research projects during the course of study
Intervention groups
The intervention framework in this study is based on Loenthal's self-regulation model(37), which educational content will be based on 5 dimensions of disease perception and also the effect that disease perception can have on patients' self-management behaviors. These dimensions are: the nature (label and symptoms related to the disease such as fatigue and weakness), the belief or reason of the person about the causes of the onset of the disease, the duration or the person's perception of the duration of the disease, the expected consequences of the person or the findings of the disease and the effectiveness of control. And improve
Main outcome variables
Self-management scale of hemodialysis patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240122060771N1
Registration date:2024-02-29, 1402/12/10
Registration timing:registered_while_recruiting
Last update:2024-02-29, 1402/12/10
Update count:0
Registration date
2024-02-29, 1402/12/10
Registrant information
Name
Ali Mohammad Parviniannasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5224 7110
Email address
ali_parviniyan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of an Education Program Based on Illness Perception on Self-Management among Hemodialysis Patients: A Randomized Controlled Trial
Public title
he Effect of an Education Program Based on Illness Perception on Self-Management among Hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be 18 years old or older.
be treated with hemodialysis for at least 3 months
Have at least two hemodialysis sessions per week.
Having independence in daily activities (walking, eating, etc.)
Able to cooperate to complete the questionnaire and carry out the intervention
Exclusion criteria:
Patients with kidney transplant experience
Unwillingness to participate in the study
ccurrence of serious physical and mental illnesses during the intervention
Participation in similar educational and research projects during the course of study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
It should be noted that this blinding study will be done in such a way that after the participants are placed in two groups of test and control, the patients will be identified with the code A for test and B for control. Blinding will be done in such a way that the study questionnaires will be completed by an informed nurse with the items of the questionnaire who is not aware of the allocation of the patients, and then the patients of the test group will be trained and at the end of the study, the questionnaire will be divided into two test and control groups. will be completed by patients and through the same nurse. In addition, the information of the patients is also specified in the statistical software with A and B code, and the statistician does not know about the patient code. It will be used blindly in some way
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of the intervention, which is educational, it is not possible to blind the participants, but the researcher who collects the data and the person who performs the statistical analysis will not know which of the intervention and control groups the patients are in. had
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Larestan University of Medical Sciences
Street address
Dadman Blvd
City
لارستان
Province
Fars
Postal code
74319-75566
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.LARUMS.REC.1402.033
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-management scale in hemodialysis patients
Timepoint
Before the intervention, immediately after the intervention and one month later
Method of measurement
Self-management questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5 sessions based on Levantal's self-regulation model for one hour per session, one session per week
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز آموزشی درمانی امام رضا (ع) لارستان
Full name of responsible person
Ali Mohammad Parviniannasab
Street address
بلوار دادمان
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 917 149 2744
Email
ali_parviniyan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohsen Salmanpor
Street address
میدان امام خمینی ، بلوار ولایت
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
علی محمد پروینیان نسب
Position
Assistant Professor of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Square, Velayat Blvd
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
علی محمد پروینیان نسب
Position
Assistant Professor if nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
میدان امام خمینی، بلوار ولایت،
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
علی محمد پروینیان نسب
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
میدان امام خمینی، بلوار ولایت،
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It can be shared after de-identifying people
When the data will become available and for how long
Access starts one year after results are published
To whom data/document is available
People working in academic and scientific institutions
Under which criteria data/document could be used
Subject to the agreement of Larestan Faculty of Medical Sciences
From where data/document is obtainable
Dr. Ali Mohammad Parviniyan Nesab, assistant professor of Larestan Faculty of Medical Sciences, email address: ali_parviniyan@yahoo.com, phone number: 07152255278, mobile number: 09171492744
What processes are involved for a request to access data/document
A written and official request to the Research Vice-Chancellor of Larestan Faculty of Medical Sciences