This study aimed to examine the effectiveness of a program of family education on burden care and quality of life in family caregivers of patients undergoing hemodialysis.
Design
A randomized controlled clinical trial study was conducted on 70 family caregivers hemodialysis patients. The subjects were equally allocated randomely into two groups of test and control group and a code allocated to each one of them.
Settings and conduct
This research was done in Noor and Ali Asghar and Zahra Marziyeh clinical centers of Isfahan. The test group received eight training sessions program of family education. Both groups answered the caregiver’s burden questionnaire and quality of life questionnaire before, immediately and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Interested in participating in the study; Being able to communicate, read and write in Persian; Care giver’s age 18 years and older; Caring for patients who have undergone kidney replacement for at least 3 months; Not participating Caregiver in family education session before; Mental and physical health of caregiver; Not treating care giver with hemodialysis; Having at least elementary educational level for the caregiver; Not being in cure team; Not using other complementary therapies such as physical therapies, acupuncture, yoga and psychotherapy sessions during the study.
Intervention groups
In this research, participants in the test group participated in 8 sessions, 90 minutes of family education program. Participants in the control group participated in 4 sessions of group discussion.
Main outcome variables
Burden care; quality of life of family caregivers of patients undergoing hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170812035635N2
Registration date:2018-03-01, 1396/12/10
Registration timing:retrospective
Last update:2018-03-01, 1396/12/10
Update count:0
Registration date
2018-03-01, 1396/12/10
Registrant information
Name
Reza Sotodeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3432 1089
Email address
reza.sotodeh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Dupty of Isfahan University of Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a family education program on care burden and quality of life in family carers of hemodialysis patients
Public title
The effect of a family education on care burden and quality of life in carers of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:Interested in participating in the study
being able to communicate read and write in persian
Care giver’s age 18 years and older
Caring for patients who have undergone kidney replacement for at least 3 months
Participants are included in the study from each family member who is the main caregiver
Take care only of a chronic illness in the family
Not participating Caregiver in family education session before
Not having features of psychosis and other psychiatric and physical disorders
Not treating care giver with hemodialysis
Having at least elementary educational level for the caregiver
Not being in cure team
Not using other complementary therapies such as physical therapies, acupuncture, yoga and psychotherapy sessions during the study
Exclusion criteria:
dealing with the crisis and the severe stress before the study
Caregiver’s refusion for participating in the research project
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly assigned to two groups of test and control using random number table.
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
•Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical sciences, Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
6628479531
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.MUI.REC.1395.3.950
Health conditions studied
1
Description of health condition studied
Chronic kideny disease(Hemodialysis)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Caregiver’s burden
Timepoint
before the intervention, immidiately after the intervention and one month after the intervention
Method of measurement
Zarit caregiver burden questionnaire
2
Description
quality of life
Timepoint
before the intervention, immidiately after the intervention and one month after the intervention
Method of measurement
quality of life -WHO short form questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, for patients in the test group, family education program was held for 8 sessions, 90 minutes, twice a week. This program provided methods for reducing care burden and improving the quality of life by providing information about the end stag of kidney disease and suitable communication of caregivers to the patient.
Category
Rehabilitation
2
Description
Control group: participants in the control group participated in 4 sessions of group discussion and expressed their feelings and experiences.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor va Aliasghar hospital
Full name of responsible person
Dr Mohammad Shamas
Street address
Noor va Aliasghar hospital, Ostandari Avenue
City
Isfahan
Province
Isfehan
Postal code
8199874875
Phone
+98 31 3792 7607
Email
shammas@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Zahra Marziyeh mediacal center
Full name of responsible person
Dr Reza Mohammadi
Street address
Toghchi square, Soroush Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
9536752164
Phone
+98 31 3792 7566
Email
mohammadi.r@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Ahmad Movahedian Attar
Street address
Isfahan University Of Medical Sicences, Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3792 3060
Email
movahedian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Saied Pahlavanzadeh
Position
MSc of psychiatric nursing, Nursing and Midwifery care Research Center, faculty member of psychiatri
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University Of Medical Sciences, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8469736248
Phone
+98 31 3792 7566
Fax
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Sotodeh
Position
Msc of psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
6859723465
Phone
+98 31 3432 1089
Fax
Email
reza.sotodeh@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Sotodeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical University, Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3228 7822
Email
reza.sotodeh@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available