Protocol summary

Summary
The purpose of this study is evaluating the effect of education based on Trans Theoretical Model on hemodialysis patient's self-care behaviors for gaining weight adjustment between dialysis sessions.Inclusion criteria: Willing to participate in the study; Patients who have hemodialysis three sessions in a week;Having at least literacy.Exclusion criteria: Participating in another similar interventional study at the same time; Unwilling to participate in the study. This study is a semi- experimental study.The study population consist of hemodialysis patients who are 12-90 years old that referred to Tehran University's hospitals. 228 patients were selected and allocated randomly two groups: Intervention group(n=114) and control group(n=114). Intervention is education by using the CD and booklet for intervention group.The information content in CD and booklets are based on Trans Theoretical Model. Control group won't receive education.Data collected by questionnaire before education and will be collected12 weeks after education. Primary outcome of this study is gaining weight adjustment between dialysis sessions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102012382N4
Registration date: 2013-12-28, 1392/10/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-28, 1392/10/07
Registrant information
Name
Zahra Rahnavard
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4206
Email address
zrahnavard@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Scienses
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of education based on Trans Theoiretical Model on hemodialysis patients self-care behaviours for gaining weight adjustment between dialysis sessions.
Public title
The effect of education based on Trans Theoretical Model on gaining weight between hemodialysis sessions.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Willing to participate in the study; Patients who have hemodialysis three sessions in a week; Having at least literacy. Exclusion criteria: Participating in another similar interventional study at the same time; Unwilling to participate in the study.
Age
From 12 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 228
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences - Poursina St
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1758/130/د/91

Health conditions studied

1

Description of health condition studied
dialysis
ICD-10 code
z49.0
ICD-10 code description
preparatory care for dialysis

Primary outcomes

1

Description
gaining weight between dialysis sessions
Timepoint
before and 12 weeks after intervention
Method of measurement
weighing by scale (kgr)

Secondary outcomes

1

Description
Hemodialysis self- care behaviours for adjusting the weight
Timepoint
before and 12 weeks after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention is education based on Trans Theoretical Model to intervention group using the CD and booklet
Category
Prevention

2

Description
The control group didn't recieve any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hasheminegad Hospital
Full name of responsible person
Zahra Rahnavard
Street address
Hasheminegad Hospital, Valinegad alley, Vanak SQ, Valiasr St
City
Tehran

2

Recruitment center
Name of recruitment center
Amiralam Hospital
Full name of responsible person
Zahra Rahnavard
Street address
Amiralam Hospital,North Saadi Street, Enghelab Avenue
City
Tehran

3

Recruitment center
Name of recruitment center
Hazrate Rasool Hospital
Full name of responsible person
Zahra Rahnavard
Street address
Rasool Hospital, Niyayesh Street, Sattar Khan Avenue
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciencesl
Full name of responsible person
Ziba Taghizadeh
Street address
Tehran University of Medical Sciences, Nursing School
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciencesl
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, Nursing School
Full name of responsible person
Zahra Rahnavard
Position
Associated Professor
Other areas of specialty/work
Street address
Nursing School, East Nosrat St, Tohid SQ
City
Tehran
Postal code
Phone
+98 212161054206
Fax
Email
zahra.rahnavard@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, Nursing School
Full name of responsible person
Zahra Rahnavard
Position
Associated Professor
Other areas of specialty/work
Street address
Nursing School, East Nosrat St, Tohid SQ
City
Tehran
Postal code
Phone
+98 21 6105 4206
Fax
Email
zahra.rahnavard@gmail.com
Web page address

Sharing plan

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