The aim of this randomized controlled clinical trial is to determine the effect of an educational intervention based on the theory of social support on improving the quality of life in hemodialysis patients. It will be done on 100 hemodialysis patients in Fatemeh Zahra hospital in Sari. First, in coordination with the hospital authorities to provide a list of patients and then from two different shifts randomly selected patients were divided into two experimental and control groups (each group, n=50). Data gathering tools are Sherborne and Stewart social support questionnaire and the World Health Organization questionnaire about quality of life. First The questionnaires are completed by both groups. Based on the analysis of the results of this stage, the intervention is designed.Educational intervention consisted of 5 sessions. The duration of each session lasting 45 minutes, and the educational methods are short lecture, group discussion, questions and answers, advice and the use of materials including booklets. Intervention take place only in the experimental group in the dialysis ward in groups of 10 runs. One month and three months after intervention in both groups questionnaires will be completed and the results will be analyzed and compared. Inclusion criteria is at least three months after initiation of dialysis patients and exclusion criteria are kidney transplant, transfer to other wards and death. The primary outcome measure is quality of life and social support is a secondary consequence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122615650N6
Registration date:2016-02-02, 1394/11/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-02, 1394/11/13
Registrant information
Name
Mahnaz Solhi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9928
Email address
solhi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Iran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on social support theory on quality of life in hemodialysis Patients
Public title
The effect of social support on quality of life
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: at least 3 month after hemodialysis
Exclusion criteria: implant; transfer to other centers; death
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Closed envelope
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Iran University of Medical Sciences, Hemmat Highway, near Milad Hospital
City
Tehran
Postal code
1449614535
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
IR.IUMS.REC.1394.27105
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
N17-N19
ICD-10 code description
renal failure
Primary outcomes
1
Description
Quality of life
Timepoint
1 and 3 month after intervention
Method of measurement
standard questionnaire for quality of life from WHO with 26 questions
Secondary outcomes
1
Description
Social support
Timepoint
1 and 3 month after intervention
Method of measurement
standard questionnaire for social support from Sherborn and Stuart
Intervention groups
1
Description
Then educational intervention is going to be done just for case group by short lecture - group discussion and booklet during 5 sessions(each of 45 min)
Category
Other
2
Description
There is no intervention for control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Laila Zhianfar
Street address
NO.14, Rahahan Building, Artesh Blvd
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Iran university of medical sciences
Full name of responsible person
Dr. Seyed Ali Javad MooOsavi
Street address
Shahid Hemmat highway, near Milad Hospital
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 and Technology, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Solhi
Position
Associate Prof.
Other areas of specialty/work
Street address
Shahid Hemmat, near Milad Hospital
City
Tehran
Postal code
Phone
+98 21 8670 4317
Fax
Email
solhi.m@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Zhianfar
Position
MS student
Other areas of specialty/work
Street address
Artesh Blvd -Rahahan building
City
Sari
Postal code
4813896567
Phone
+98 11 3329 7274
Fax
Email
1649lzh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Solhi
Position
PhD/Associate Prof.
Other areas of specialty/work
Street address
Department of Health Services and Health Education, School of Health , Iran University of Medical Sciences, Near Milad Hospital, Shahid Hemmat Highway, Tehran
City
Postal code
1449614535
Phone
+98 21 8670 4817
Fax
Email
solhi.m@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)