This study was conducted with the aim to determine the effect of self-management program on quality of life for kidney transplant patients referred to Isfahan’s Charity Center of Hazrat-e-Abolfazl (AS) in 2015. This study is a clinical trial with two groups and three stages which was conducted before, immediately, and three months after the intervention. In this research, the impact of independent variable of self-management program on the dependent variable of life quality was evaluated in kidney transplant patients. Research environment is the Charity Center of Hazrat-e-Abolfazl (AS). The main inclusion criterion: a minimum age of 18 years; at least three months have passed from the time of their kidney transplant; And the main criterion for exclusion was absence of more than one session in the training sessions; hospitalization or death during the study. A total of 64 kidney transplant patients who met the inclusion criteria, were recruited by convenience sampling method. Eventually, selected samples were randomly put in two intervention group (n = 32) and control group (n = 32). After putting the patients into two intervention and control groups, the intervention group received self-management training program in chronic diseases. This training program was a 15-hours community-based program that was provided at 2.5-hour meetings during 6 weeks. The study lasted about a month. A session was also held for the control group with educational content diet. Information in this study was completed before, immediately, and three months after in questioning way by using Quality of Life Questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062828457N4
Registration date:2016-07-24, 1395/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-24, 1395/05/03
Registrant information
Name
Somayye Kuwaity
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 933 241 0966
Email address
somayyekuwaity@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of self-management programs on quality of life in patients with kidney transplant
Public title
Self-management program impact on the quality of life in patients with kidney transplant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Minimum age of 18 years; At least three months have passed from the time of their kidney transplant; Capable of reading and writing in Persian language to complete a questionnaire; They do not simultaneously participate in another study ; Willingness to participate in the study ; Have no mental retardation, blindness and deafness.
Exclusion criteria: Unwillingness of the patient to continue for participating in the study; Hospitalization or death during the study ; Absence of more than one session in training sessions.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Isfahan University of Medical Sciences
Street address
Hezar Jerib Avenue, Isfahan University of Medical Sciences, School of Nursing and Midwifery, Isfahan
City
Isfahan
Postal code
81746-73461
Approval date
2016-01-20, 1394/10/30
Ethics committee reference number
394732
Health conditions studied
1
Description of health condition studied
Kidney transplant patients
ICD-10 code
z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Quality of life
Timepoint
Before, immediately, and three months after intervention
Method of measurement
Quality of Life Questionnaire for patients with renal transplantation
Secondary outcomes
1
Description
Quality of life
Timepoint
Before, immediately, and three months after intervention
Method of measurement
Quality of Life Questionnaire for patients with renal transplantation
Intervention groups
1
Description
Intervention group: Workshops were held weekly over a six week period, with each session taking 2.5 h to complete.
Category
Lifestyle
2
Description
control group: Received a training session on nutrition
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan’s charity society of Hazrat-e-Abolfazl (AS)
Full name of responsible person
Ahmad Famil Dardashti
Street address
In front of Poshte Matbakh alley, Ostandari Street , Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ashraf Kazemi
Street address
Hezar Jerib Avenue, School of Nursing and Midwifery, Isfahan-
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Somayye Kuwaity
Position
M.A student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences Dormitory, Isfahan