The purpose of this study is to determine the effect of illness perception intervention on clinical outcomes of hemodilysis patients. This study is a randomized clinical trial which in, hemodialysis patients will be selected by simple sampling method and randomly will be divided into experimental and control groups. The intervention group will receive illness perception intervention and control group will receive routine care. Clinical outcomes will be divided into two categories: primary and secondary outcomes. Primary outcomes includes adherence to the treatment and quality of life and secondary outcomes includes physiological parameters. First, questionnaires including demographic data, quality of life for hemodialysis patient questionnaire (KDQOL-SFTM) and ESRD-AQ and illness perception questionnaire (Brief-IPQ) and laboratory indicators (IDWQ, K,P, BUN, Cr, Ca. Albumin, Hg, Htc )will be completed. The illness perception interventions will be presented within 6 meeting sessions uniquely. 8 weeks after intervention, the questionnaires and physiological parameters will be completed again. All analyses will be performed by SPSS and independent T-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204246918N9
Registration date:2012-05-19, 1391/02/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-19, 1391/02/30
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of illness perception Interventions on some clinical outcomes in hemodialysis patient : Randomized Controlled Trial
Public title
illness perception
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: men and women over 18 years of hemodialysis patients, the diagnosis of ESRD andCurrently receive HD over six months and receiving HD three times a week, physical and mental condition to complete the questionnaire and receive appropriate interventions, patient-oriented and
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:
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
Tabriz University of Medical Sciences
Street address
Shariety South St ; Faculty of Nursing & Midwifery of Tabriz ;
City
Tabriz
Postal code
Iran
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
9175
Health conditions studied
1
Description of health condition studied
end stage renal disease-hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
adherence to treatment
Timepoint
before intervention- 8 week after intervention
Method of measurement
end stage renal disease adherence questionnaire
2
Description
Quality of life
Timepoint
before intervention- 8 week after intervention
Method of measurement
quality of life for hemodialysis patient questionnaire (KDQOL-SFTM)
The control group will be received only routine interventions.
Category
Lifestyle
2
Description
Groups in addition to routine interventions, interventions related to the perception of the disease will receive. Interventions to implement clinical researcher regularly scheduled dialysis patients will be present. During the six 45-minute session will attempt to correctly identify the disease knowledge and self-regulated Gary teach. 6 sessions will be conducted once a week for 1.5 months. These interventions, based on the five illness perception and the perception that the disease can also affect patient compliance and clinical outcomes in behavior has caused it to be based. Interventions to be adjusted for each patient were unique.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Talegani Educational Center Affiliated Medical Sciences of Urmia;Iran
Full name of responsible person
Street address
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr.Rashidi
Street address
Shariety South St ; Faculty of Nursing & Midwifery of Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery of Tabriz
Full name of responsible person
jaleh rahimi
Position
Nursing Master of Science Student
Other areas of specialty/work
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
tabriz
Postal code
5138947977
Phone
+41 13820967
Fax
Email
tm.rahimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)