Determining the effect of self-care training program on self-efficacy and quality of life of hemodialysis patients
Design
A two-group clinical trial with a control group, with parallel groups, randomized, with the participation of 100 patients.
Settings and conduct
The present study will be conducted as a two-group randomized clinical trial with the participation of 68 patients undergoing hemodialysis referred to Shahid Beheshti hospital in Hamedan in 2023. Patients will be randomly assigned to intervention and control groups. In the intervention group, the self-care training program will be carried out. The sessions of the self-care training program will be held during 6 sessions during two weeks for 10-15 minutes exclusively for each person, on each patient's bed. Evaluation of self-efficacy and quality of life after self-care training intervention will be done one and two months after the last care session. In order to achieve more patients' participation and to minimize sample loss, an electronic questionnaire will be used to complete the questionnaire (one and two months after the intervention) in both groups. Patients in the control group will receive only the routine care of the department and no special action will be taken for them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Access to smart phones, Ability to communicate verbally, Having at least reading and writing literacy
Exclusion criteria: Not completing the questionnaire completely, Unwillingness to continue cooperation
Intervention groups
Intervention group: The self-care training program will be conducted for the intervention group. The sessions of the self-care training program will be held during 6 sessions for 10-15 minutes specifically for each person, on each patient's bed.
Control group: The control group will receive only routine care.
Main outcome variables
Self-efficacy and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N42
Registration date:2023-01-05, 1401/10/15
Registration timing:prospective
Last update:2023-01-05, 1401/10/15
Update count:0
Registration date
2023-01-05, 1401/10/15
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-care training program on self-efficacy and quality of life of hemodialysis patients
Public title
Effect of self-care training program on self-efficacy and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least reading and writing literacy
Ability to communicate verbally
Access to smart phones
Exclusion criteria:
Unwillingness to continue cooperation
Not completing the questionnaire completely
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, four random blocks method is used. For this purpose, four sheets of paper are prepared. The letter A (intervention) is written on two sheets and the letter B (witness) is written on the other two sheets. The sheets are mixed together and removed by the researcher consecutively without placing them. This process is repeated for the number of qualified patients and whether each patient is group A or B is recorded.
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 of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2022-10-22, 1401/07/30
Ethics committee reference number
IR.UMSHA.REC.1401.629
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
I13.2
ICD-10 code description
Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease
Primary outcomes
1
Description
Self-efficacy
Timepoint
Before and two months after the intervention
Method of measurement
Sherer general self-efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the self-care training program will be carried out. The sessions of the self-care training program will be held during 6 sessions during two weeks for 10-15 minutes exclusively for each person, on each patient's bed. Educational content will include infection prevention education, proper nutrition, how to take medications, explanations about exercise, sleep, and sexual activities. These trainings will be face-to-face training.
Category
N/A
2
Description
Control group: Control group: Patients in the control group will receive only limited and routine care and education, such as vascular access site care and nutrition, and no special action will be taken for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Firouzeh Beiranvand
Street address
Hamedan - the beginning of Eram Boulevard - Shahid Beheshti Hospital
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
firoozebeiranvand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokouhi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
R.shokouhi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Firoozeh Beiranvand
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
firoozebeiranvand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Firoozeh Beiranvand
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
firoozebeiranvand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.ac.ir
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