determining The Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients Referring to Dialysis Centers in Selected Hospitals of Shahid Beheshti University of Medical Sciences in 2019
Design
A randomized, double-blind, placebo-controlled clinical trial with a sample size of 35 in each group
Settings and conduct
In this study, after determining the sample size, sampling will be done by available method and patients will be randomly assigned to two groups. In the experimental group, self-efficacy program with usual care is offered to hemodialysis patients and in the control group routine care is performed. The program will be run through six sessions, with the creation of a WhatsApp or Telegram group, which will include a self-efficacy training program.
Participants/Inclusion and exclusion criteria
inclusion criteria:
ages 18-65 years old
having the verbal communication ability
having the ability of self-care activities
having the history of dialysis at least for past one year
having dialysis 3-4 times per week
having the skill of using of Virtual messenger
exclusion criteria:
1.psychological disorders like psychosis and acute depression which needed to be hospitalized
2.Unwillingness to continuing participate in research
3.Any emergency event that may lead the patient to the intensive care unit.
Intervention groups
The intervention consisted of providing a self-efficacy training program that included aspects of participation in treatment, problem solving, self-care, and emotion control, and runs over 6–12 weeks. The intervention group will receive a self-efficacy training program in addition to routine nursing care in the ward. The control group will receive only routine care in the ward.
Main outcome variables
self managemet
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191215045747N1
Registration date:2020-02-09, 1398/11/20
Registration timing:retrospective
Last update:2020-02-09, 1398/11/20
Update count:0
Registration date
2020-02-09, 1398/11/20
Registrant information
Name
armin azizikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3633 8120
Email address
arminazizikya@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients
Public title
The Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
ages 18-65 years old
having the verbal communication ability
having the ability of self-care activities
having the history of dialysis at least for past one year
having dialysis 3-4 times per week
having the skill of using of Virtual messenger
Exclusion criteria:
Age
From 18 years old to 65 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
We drop a coin and one side is the control group and the other is the intervention group. We assign the first patient to the group based on the result and the next sample is assigned to the opposite group.
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 Shahid Beheshti University of Medical Sciences
Street address
Ferdos Dormitory., Sought Ramin St., East Ferdos Blvd., Sadeghieh District., Tehran Town
City
Tehran
Province
Tehran
Postal code
1481999586
Approval date
2019-12-02, 1398/09/11
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.244
Health conditions studied
1
Description of health condition studied
Chronic kidney Disease and Hemodialysis
ICD-10 code
Z99.2
ICD-10 code description
Applicable To Chronic kidney disease requiring chronic dialysisUse Additional code to identify dialysis status (Z99.2 )The following code(s) above N18.6 contain annotation back-referencesthat may be applicable to N18.6: N00-N99 Diseases of
Primary outcomes
1
Description
self-management score
Timepoint
determining Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients before and after intervention
Method of measurement
The hemodialysis self-management instrument (HDSMI) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Once the validity of the educational content has been confirmed, the intervention group will form a virtual group at telegram or whatsapp and the training program will be delivered to them through the virtual program within 6-12 weeks. In addition, the intervention group will receive routine care.
Category
Other
2
Description
Control group: The control group is similar to the intervention group but will not receive any training or intervention except routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafi Nejad Hospital
Full name of responsible person
Armin Azizikia
Street address
Ferdos Dormitory., Sought Ramin St., East Ferdos Blvd., Sadeghieh District., Tehran Town
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 44 3633 8120
Email
Arminazizikya@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahrokh Dolatian
Street address
Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
mhdolatian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Armin Azizikia
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ferdos Dormitory., Sought Ramin St., East Ferdos Blvd., Sadeghieh District., Tehran Town
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 44 3633 8120
Email
Arminazizikya@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Armin Azizikia
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ferdos Dormitory., Sought Ramin St., East Ferdos Blvd., Sadeghieh District., Tehran Town
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 44 3633 8120
Email
arminazizikya@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Armin Azizikia
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ferdos Dormitory., Sought Ramin St., East Ferdos Blvd., Sadeghieh District., Tehran Town
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 44 3633 8120
Email
Arminazizikya@sbmu.ac.ir
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
The result of the research is whether self-efficacy can improve self-management or not.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
researcher
Under which criteria data/document could be used
Raising awareness and guiding research for other people
From where data/document is obtainable
researcher
What processes are involved for a request to access data/document