پDetermining the effect of educational program based on Orem self-care model on adherence to treatment, self-care behaviors and quality of life in hemodialysis patients
Design
The present study is a double-blind randomized clinical trial that will be performed on 80 patients with end-stage renal disease undergoing hemodialysis who are divided into intervention (40 patients) and control (40 patients) groups. The training intervention will be performed only for the intervention group and the control group will receive only the pamphlet and training package. Before, immediately and three months after the intervention, the questionnaire of quality of life, self-care and adherence to treatment will be completed for both intervention and control groups.
Settings and conduct
The study site will be the hemodialysis ward of Peymaniyeh Hospital in Jahrom. The study of randomized clinical trial will be double-blind
Participants/Inclusion and exclusion criteria
Inclusion criteria include: age 15 to 70 years, not attending training classes during the last 3 months, no mental health problems, having primary education, not having chronic diseases such as liver cirrhosis, end-stage cancer, having the ability for informed consent
Exclusion criteria include: death of the patient, incompleteness of the questionnaire, kidney transplantation
Intervention groups
The training based on the Orem self-care model will be held virtually through 4 group classes of 20 people through WhatsApp program and phone message.
Main outcome variables
Adherence to treatment - quality of life - self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N2
Registration date:2021-12-31, 1400/10/10
Registration timing:prospective
Last update:2021-12-31, 1400/10/10
Update count:0
Registration date
2021-12-31, 1400/10/10
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education based on Orem theory on quality of life, adherence to treatment and self-care of hemodialysis patients
Public title
The effect of education on quality of life, adherence to treatment and self-care of hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include: age 15 to 70 years, not attending training class during the last 3 months, no mental health problem, having primary education, no chronic disease such as liver cirrhosis, end-stage cancer, ability to consciously satisfy exit conditions : Death of the patient, incompleteness of the questionnaire, kidney transplantation
Exclusion criteria:
Exclusion criteria include: death of the patient, incompleteness of the questionnaire, kidney transplantation
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
40
40 people in the intervention group and 40 people in the control group
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is a simple random assignment, such as in an 80-card envelope with the letter A written on 40 cards and the letter B on the other 40 cards. Patients who meet the inclusion criteria are asked to pick up a card. If they pick up card A, they will be in the test group and if they pick up card B, they will be in the control group and this process will continue until the sample size is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blind study in which both participants and researchers or outcome assessors are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Other
Other design features
The present study is a double-blind randomized clinical trial intervention that will be performed on 80 patients with end-stage renal disease undergoing hemodialysis who are divided into two groups of intervention and control. To determine the sample size, the average comparison formula in the two dependent groups will be used. In the study of the effect of applying the Orem self-care model on the quality of life of patients undergoing hemodialysis, conducted by Soleiman Naroui et al., 35 patients were selected as the sample size. The minimum sample size in each group in this study was 16 people. Due to the possibility of falling samples in the present study, 40 people will be selected in each groupOrem self-care model training through 4 groups of 20 people, which will be held virtually by WhatsApp and phone message due to coronary conditions. Classes will be held for 1 hour in the form of group discussions and lectures with educational pamphlets (due to coronary conditions and the need to prevent and control infection, especially in patients with end-stage renal disease, we tried to use educational booklets, educational pamphlets and telephone calls). After stating the objectives of the study for patients obtaining informed written consent during the first session of chronic renal failure, its cause, exacerbating factors, complications of the disease, its effects on life, exacerbating factors and improving and reducing factors in the second session with In the third session, the importance of participation in communities, weight care, sexual activity, exercise, self-care activities, and in the fourth session, the importance of adhering to the schedule, refer to The doctor will be instructed to refer to dialysis and follow the treatment. Educational pamphlets will also be provided to them. The scientific content of the training program will be designed and approved by 10 nursing professors and 5 kidney specialists. No educational intervention will be performed for patients in the control group and only pamphlets and educational content will be given to them. Before the training, immediately after the training and three months after the training in the control and intervention group, the questionnaire of quality of life, self-care and adherence to treatment will be completed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Fasa University of Medical Sciences
Street address
Ibn Sina Street. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2021-12-21, 1400/09/30
Ethics committee reference number
IR.FUMS.REC.1400.110
Health conditions studied
1
Description of health condition studied
Diseases of the urinary system
ICD-10 code
GC2Z
ICD-10 code description
Diseases of the urinary system
Primary outcomes
1
Description
adherence to treatment
Timepoint
Before, immediately and three months
Method of measurement
Treatment Adherence Questionnaire
2
Description
Self-care behaviors
Timepoint
Before, immediately and three months
Method of measurement
Self-care behavior questionnaire
3
Description
Quality of life
Timepoint
Before, immediately and three months
Method of measurement
Quality of life questionnaire for kidney patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Orem self-care model training through 4 groups of 20 people, which will be held virtually by WhatsApp and phone message due to coronary conditions. Classes will be held for 1 hour in the form of group discussions and lectures with educational pamphlets (due to coronary conditions and the need to prevent and control infection, especially in patients with end-stage renal disease, we tried to use educational booklets, educational pamphlets and telephone calls). After stating the objectives of the study for patients obtaining informed written consent during the first session of chronic renal failure, its cause, exacerbating factors, complications of the disease, its effects on life, exacerbating factors and improving and reducing factors in the second session with In the third session, the importance of participation in communities, weight care, sexual activity, exercise, self-care activities, and in the fourth session, the importance of adhering to the schedule, refer to The doctor will be instructed to refer to dialysis and follow the treatment. Educational pamphlets will also be provided to them. The scientific content of the training program will be designed and approved by 10 nursing professors and 5 kidney specialists.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom Peymaniyeh Hospital
Full name of responsible person
Samira Rezaei
Street address
Motehari street. Jahrom Peymaniyeh Hospital
City
Jahrom
Province
Fars
Postal code
07461445135
Phone
+98 21 5335 0994
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Ibn Sina Street. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
Farjam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
02153350994-6
Email
bizhani_mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
02153350994-6
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
02153350994-6
Email
bizhani_mostafa@yaahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Until the end of 1401
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to the data and documentation will be provided upon request and approval of the research team members
From where data/document is obtainable
The main executor of the project is Dr. Mostafa Bijani. Fasa Medical Sciences
What processes are involved for a request to access data/document
Receive a request to use the documentation and submit the documentation within 2 weeks