The effect of training based on Haddon's strategy on self-care and common disease outcomes of patients with chronic kidney failure treated with hemodialysis
The effect of training based on Haddon's strategy on self-care and common disease outcomes of patients with chronic renal failure treated
with hemodialysis
Design
Clinical trial with a control group, with parallel groups, on 92 patients. For randomization, the method of permuting blocks of 6 will be used by computer software.
Settings and conduct
The present study will be conducted as a randomized clinical trial with the participation of 92 patients with chronic renal failure treated with hemodialysis referred to Shahid Sadoughi Hospital in Yazd. Patients will be randomly divided into two intervention and control groups. In the test group, the researcher will provide self-care training based on Haddon's strategy in three sessions for 30-60 minutes. Haddon's strategy is about teaching self-care behavior to reduce risk factors and disease complications.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years
absence of speech, hearing, and cognitive problems
History of hemodialysis at least 3 months;
Exclusion criteria: Unwillingness to participate in the study
Intervention groups
In the intervention group, the researcher will provide self-care training based on Haddon's strategy in three sessions for 30-60 minutes. Haddon's strategy is about teaching self-care behavior to reduce risk factors and disease complications.
Patients in the control group will receive only the usual care and education of the hospital.
Main outcome variables
The level of self-care and disease complications(outcomes)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240215061016N1
Registration date:2024-04-30, 1403/02/11
Registration timing:prospective
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
shirin ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3837 0133
Email address
sh.ranjbarghanei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2025-01-18, 1403/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training based on Haddon's strategy on self-care and common disease outcomes of patients with chronic kidney failure treated with hemodialysis
Public title
The effect of training based on Haddon's strategy on self-care and common disease outcomes in hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Absence of speech, hearing, and cognitive problems
History of hemodialysis at least 6 months
Exclusion criteria:
Unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to two intervention and control groups, tables of 6 blocks (table of random numbers) will be used. In this way, a number is included for the names of the registered people, then using 6 block tables and random allocation software, these numbers are randomly placed in one of the two groups(intervention and control).
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
Research Institute of Reproductive Sciences - Shahid Sadougi University of Medical Sciences, Yazd (R
Checklist(Checklist researcher- made) of disease complications(including: shortness of breath, lower extremity edema, rest and activity disorders, chest pain, etc.)
Intervention groups
1
Description
Intervention group: In the intervention group, the researcher will provide self-care training based on Haddon's strategy in three sessions for 30-60 minutes. Haddon's strategy is about teaching self-care behavior to reduce risk factors and disease complications. In this regard, the first session will provide training on the nature and causes of the disease and warning signs. In the second session, the focus of education will be on medication regimen and diet, and in the third session, the focus will be on the balance between activity and rest, daily weighing and monitoring symptoms of disease exacerbation, stress control and urinary output.
Category
Other
2
Description
Control group: Patients in the control group will receive only the usual care and education of the hospital.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid sadoughi hospital
Full name of responsible person
Shirin Ranjbar
Street address
BouAli st., Safaeih,Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
ranjbar.shirin2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shirin Ranjbar
Street address
BouAli st., Safaeih,Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
ranjbar.shirin2014@gmail.com
Web page address
http://web.ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشگاه علوم پزشکی شهید صدوقی یزد
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
Yazd University of Medical Sciences
Full name of responsible person
Shirin Ranjbar
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
BouAli st., Safaeih,Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
ranjbar.shirin2014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shirin Ranjbar
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
BouAli st., Safaeih,Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
ranjbar.shirin2014@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shirin Ranjbar
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
BouAli st., Safaeih,Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
00098 35 3824 1751
Email
ranjbar.shirin2014@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available