The effect of self-regulation training on weight change in patients treated by hemodialysis
Design
A clinical trial study that is easy and convenient sampling and randomization in groups
Settings and conduct
It was a clinical trials study. The research population of hemodialysis patients referring to Shahid Hasheminejad Hospital will be divided into two groups: test and comparison. Research environment: Hemodialysis section of Shahid Hasheminejad Hospital
Participants/Inclusion and exclusion criteria
Entry criterion: more than 18 years, have studying and writing skill, should be hemodialized for at least 3 months. The average weight gain of 6 sessions of dialysis is more than 2.5 kg, Non-participation in the study or training in relation to compliance with fluid restriction simultaneously with the impact of self-regulation training, no kidney transplant history and no psychological problems, awareness of time, place and person. Exit criteria: have no desire to attend in the study, be hospitalized, Participants in the study died, do not attend in 2 sessions of training
Intervention groups
Chronic renal patients who treated by hemodialysis and do not observe the limitations of fluid intake.
Main outcome variables
Self-regulation, Adherence with fluid-intake restriction, Body Weight changes, hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040254N1
Registration date:2018-11-30, 1397/09/09
Registration timing:retrospective
Last update:2018-11-30, 1397/09/09
Update count:0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
Zeinab Afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 7741
Email address
zeinabafshar94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-22, 1397/04/31
Expected recruitment end date
2018-09-20, 1397/06/29
Actual recruitment start date
2018-07-31, 1397/05/09
Actual recruitment end date
2018-10-01, 1397/07/09
Trial completion date
2018-10-11, 1397/07/19
Scientific title
Effect of a Behavioral Self-Regulation Education on Weight Changes in Hemodialysis Patients
Public title
Effect of a Behavioral Self-Regulation Education on Weight Changes in Hemodialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
More than 18 years
Have studying and writing skill
Should be hemodialized for at least 3 months
The average weight gain of 6 sessions of dialysis is more than 2.5 kg
Non-participation in the study or training in relation to compliance with fluid restriction simultaneously with the impact of Self-regulation training
No kidney transplant history and no psychological problems
Awareness of time, place and person
Exclusion criteria:
Have no desire to attend in the study
Be hospitalized
Participants in the study died
Do not attend in 2 sessions of training
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
An easy and accessible sampling method was used. Therefore people who come to the dialysis unit will be selected and by completing the weighing table two weeks before the intervention and average calculating for 6 consecutive dialysis sessions, identified peoples who are not following the limitations of fluid intake and if have the criteria for entering the study, the informed consent form and the form of the demographic information will be completed by samples. Qualified persons will be placed in two groups randomly (odd or even days). By coin tossing the test and comparison groups (test group with letter A and comparison group with letter B) will be specified.
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 Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-08-10, 1396/05/19
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411449001
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Weight Changes of undergoing hemodialysis patients
Timepoint
Two weeks before the intervention, 2 weeks and 3 months after the intervention
Method of measurement
Weight was measured by calibrated digital weighing scales
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, self-regulatory behavior training based on the Kanfer framework included self-observation, self-assessment, and self-enhancement of a target behavior. In the form of face-to-face training, with the presence of a researcher and a psychologist of behavioral science for 7 weeks, each week, an hour of meeting with the subjects will be performed.Trainings are more about discussing people's problems and leading to solving problems. The content of each session will be determined by the progress of each session and the individual's requirements. First session: introduction of self-regulation practices and its relationship with the regime of dialysis treatment. Brief overview of fluids and long-term complications and noncompliance will be done. Second session: An overview of the relationship between self-regulatory processes of behavior (eg self-observation, self-assessment, self-esteem) and goal behavior. Session 3: Self-reflection will be reviewed and discussed. Session Four: Self-monitoring skills and the beginning of night-time assignments include their own monitoring of daily fluid intake, mood, and behaviors that lead to over-consumption of fluid in the setting of fluid intake and people will set goals for fluid intake. Fifth Session: Finding you’re Strengthening Strategies. Sixth Session: Learning about controlling stimulus behaviors. Seventh session: review and evaluation of experiences Group.
Category
Prevention
2
Description
Comparison Group: In the comparison group, with the collaboration of a nursing staff member of the Shahid Hasheminejad Hospital's Dialysis Hospital, (Training routine will be repeated) regular training will be provided for 7 weeks, each meeting will receive an appointment with a nurse for one hour. It includes: The first session will be a public discussion of how hemodialysis will be treated. Second Session: Why behavior change (including fluid intake) is important for success and quality of life. Third Session: How the disease affects family members and relatives. Fourth Session: The importance of active participation in Dialysis Sessions. Fifth Session: The importance of patient’s interaction and dialysis providers to provide dialysis schedules to set dialysis programs. Sixth Session: logistical problems related to dialysis (for example: patients who are traveling). Seventh session: Completion of the meeting will be discussed with an overview of the discussions.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Hasheminejad Hospital Tehran
Full name of responsible person
Kazem Malakoti
Street address
Valinezhad St. Vali-e-Asr Ave.
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 2501 5080
Email
PR@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Kazem Malakoti
Street address
Hemmat High way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Zeinab Afshar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rashid Yasemi st. Vale asr Aven.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8820 1978
Fax
Email
zeinabafshar94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Jaleh mohammad- aliha
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rashid Yasemi St. Valeasr Ave
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8820 1978
Email
mohammadaliha.j@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeinab Afshar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rashid Yasemi St. Valeaser Ave
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8820 1978
Fax
Email
zeinabafshar94@gmail.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
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
All the potential data can be shared after unidentifiable people
When the data will become available and for how long
After paper publication that is taken from article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Academic research that mentioned to cite this article
From where data/document is obtainable
E-mail responsible for the general response to the trial
What processes are involved for a request to access data/document
A month after the receipt of the email will be sent