Protocol summary
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Study aim
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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
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Design
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A prospective, randomized, open-label, routine care–controlled trial with a sample size of 35 in each group.
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Settings and conduct
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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, a self-efficacy program in addition to usual care is offered to hemodialysis patients, and in the control group only routine care is provided. The program will be run through 12 sessions, delivered over a period of 6 to 12 weeks, through the creation of a WhatsApp or Telegram group, which will include a self-efficacy training program.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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self managemet
General information
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Reason for update
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This update includes:
1. Completion of the previously empty "Actual recruitment start/end date" and "Trial completion date" fields, based on the actual study timeline.
2. Addition of contact information for six additional recruitment centers (beyond the originally registered center) that participated in the actual conduct of the study.
3. Correction of the study design description in the protocol summary from "double-blind/placebo-controlled" to "open-label/routine care-controlled," consistent with the actual methodology.
4. Correction of the number of intervention sessions from 6 to 12, consistent with the approved proposal and protocol.
5. Correction of the number of intervention sessions from 6 to 12 in the "Intervention Groups" section (consistent with the approved proposal and protocol), and reclassification of the intervention type for both groups from "other" to "behavioral."
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191215045747N1
Registration date:
2020-02-09, 1398/11/20
Registration timing:
prospective
Last update:
2026-10-02, 1405/07/10
Update count:
1
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Registration date
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2020-02-09, 1398/11/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-21, 1397/11/01
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Expected recruitment end date
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2019-03-21, 1398/01/01
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Actual recruitment start date
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2020-02-20, 1398/12/01
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Actual recruitment end date
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2020-04-19, 1399/01/31
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Trial completion date
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2020-07-21, 1399/04/31
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Scientific title
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The Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients
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Public title
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The Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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:
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
Actual sample size reached:
61
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-12-02, 1398/09/11
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1398.244
Health conditions studied
1
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Description of health condition studied
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Chronic kidney Disease and Hemodialysis
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ICD-10 code
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Z99.2
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ICD-10 code description
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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
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Description
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self-management score
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Timepoint
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determining Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients before and after intervention
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Method of measurement
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The hemodialysis self-management instrument (HDSMI) questionnaire
Intervention groups
1
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Description
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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 in 12 sessions within 6-12 weeks. In addition, the intervention group will receive routine care.
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Category
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Behavior
2
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Description
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Control group: The control group is similar to the intervention group but will not receive any training or intervention except routine care.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The result of the research is whether self-efficacy can improve self-management or not.
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When the data will become available and for how long
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Start of access period 6 months after printing results
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To whom data/document is available
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researcher
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Under which criteria data/document could be used
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Raising awareness and guiding research for other people
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From where data/document is obtainable
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researcher
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What processes are involved for a request to access data/document
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Send academic email requesting results
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Comments
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