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The effect of blended education on dialysis adequacy and nutritional status in patients with hemodialysis

Protocol summary

Summary
This study will be conducted to determine the effect of blended education on dialysis adequacy and nutritional status of hemodialysis patients. In this study, 60 patients referred to a dialysis center are divided into two groups: intervention group (30) and control group (30), according to going to the center on odd or even days and by throwing a coin. Dialysis patients with at least six months and at least two dialysis sessions per week, aged 18-65 years, and stable clinical status will be enrolled, and those with a lack of adherence to treatment regimens anticipated or those who participate in other courses, will be excluded. Patients in the intervention group will be conducted a needs assessment during the first meeting. Then, educational materials in the field of protection for vascular access, nutrition education, physical activity and medications will be provided in two group sessions and two individual sessions. Individual sessions will focus on the educational needs of the patient. At the end of the meeting, booklets will be provided. Group sessions will take 30 minutes and individual sessions 10 minutes. Then, every two weeks to the end of study, a telephone conversation with patient for answers to questions and emphasis on educational materials will be done .In this study, dialysis adequacy based on the Urea Kinetic Modeling and Urea Reduction Rate and nutritional status based on subjective global assessment questionnaire at baseline, one month and two months after the start of the study will be discussed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121025457N1
Registration date: 2016-01-25, 1394/11/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Mojtaba Rayati
Name of organization / entity
Shahed University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8590
Email address
m.rayati@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Shahed University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-17, 1394/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of blended education on dialysis adequacy and nutritional status in patients with hemodialysis
Public title
The effect of blended education on dialysis adequacy and nutritional status
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: At least 6 months Dialysis; at least two dialysis sessions per week; Age 18-65 years; stable clinical situation. Exclusion criteria: Lack of adherence to treatment regimens anticipated; Participation in other training course
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, patients referred to the center on odd or even days, are divided into tow groups by throwing a coin.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahed University of Medical Sciences
Street address
Shahed University of Medical Sciences, Infront of the Shrin of Imam Khomeini, Tehran - Qom Freeway
City
Tehran
Postal code
Approval date
2015-09-11, 1394/06/20
Ethics committee reference number
Shahed.REC.1394.27

Health conditions studied

1

Description of health condition studied
Chronic kidney disease
ICD-10 code
n18.5
ICD-10 code description
End stage kidney disease on dialysis

Primary outcomes

1

Description
Dialysis adequacy
Timepoint
Before intervention one month after the intervevtion and two months after the intervention
Method of measurement
DaugirddasII

2

Description
Dialysis adequacy
Timepoint
Before intervention one month after the intervevtion and two months after the intervention
Method of measurement
Urea Reduction Rate (URR)

Secondary outcomes

1

Description
Nutritional status
Timepoint
Before intervention, one month after intervention and two months after the intervention
Method of measurement
Subjective Global Assessment Questionnaire

Intervention groups

1

Description
Intervention group: In addition to routine dialysis training in the intervention group, patients also will receive integrated training. In the first session of this group, individual interviews are done to determine the educational needs of patients. During dialysis the next day and a 3-2 persons group sessions during 20-30 minutes will be held on hemodialysis Diet. The more an individual session will be based on patient needs .The next day a group meeting will be done on the protection of vascular access،physical activity and medicines .And then an individual session will be done In this context based on patient needs .At the end of the sessions will be presented the pamphlet. Then, a telephone conversation with patient and answers to questions and emphasis on educational materials will be done every two weeks to the end of study. Within one month after intervention and two months after intervention dialysis, adequacy and nutritional status will be reviewed.
Category
Lifestyle

2

Description
Control Group: At the beginning of the study, the adequacy of dialysis and nutritional status will be reviewed in the control group. During the study, patients will receive only training routine dialysis. Then, one month after intervention and two months after the start of the study, the adequacy of dialysis and nutritional status will be reviewed.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Maryam Pakfetrat
Street address
Zand Street, Shahid Faghihi Hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Shahed University of Medical Sciences
Full name of responsible person
Zahra kiasalari
Street address
Shahed University of Medical Sciences, Infront of Shrin of Imam Khomeini, Tehran - Qom Freeway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Shahed University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery Shahed
Full name of responsible person
Mojtaba Rayati
Position
Msc of nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Shahed, Alley Rahimzadeh, Valiasr Intersection of Taleghani
City
Tehran
Postal code
Phone
+98 21 6641 8590
Fax
Email
m.rayati@shahed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery Shahed
Full name of responsible person
Maryam Jadid Milani
Position
PHD Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery Shahed, Alley Rahimzadeh, Valieasr Intersection of Taleghani
City
Tehran
Postal code
Phone
+98 21 6640 8590
Fax
Email
milani2000ir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery Shahed
Full name of responsible person
Mojtaba Rayati
Position
Msc nursing student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Shahed, Alley Rahimzadeh, Valieasr Intersection of Taleghani
City
Tehran
Postal code
Phone
+98 21 6641 8590
Fax
Email
m.rayati@shahed.ac.i
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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