The effect of self-care education on the quality of life in renal transplant patients referring to Imam Reza hospital in Tabriz, 2017- 2018
Design
Sample size consist of 60 patients in a blind, randomized clinical trial.
By using the records number and the www.random.org site two intervention and control groups will be determined
Settings and conduct
A study in Imam Reza Hospital in Tabriz Individual face-to-face education with a booklet will be done for 3 sessions with 30 to 45 minutes intervals every two days.
Participants/Inclusion and exclusion criteria
Inclusive criteria is age range, 18-60 years old and ability to read and write, at least 5 days after kidney transplant ion and no suffering from physical inability and disability, psychiatric illness and other serious chronic diseases that disrupt quality of life like types of cancer or Alzheimer disease. They should have a tendency to participate in research. A phone call can be provided for them. Exclusive criteria will be absence of more than one session of self-care education sessions, being reluctant to participate in the study, migration and death of participants.
Intervention groups
Kidney transplant patients will be studied in two control and intervention groups.Individual face-to-face education with a booklet will be done for 3 sessions with 30 to 45 minutes intervals every two days.The data collection tool KTQ-25 was be completed before and after the intervention, for both groups in Tabriz Imam Reza hospital.
Main outcome variables
quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160220026662N3
Registration date:2018-09-10, 1397/06/19
Registration timing:retrospective
Last update:2018-09-10, 1397/06/19
Update count:0
Registration date
2018-09-10, 1397/06/19
Registrant information
Name
Nader Aghakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4816
Email address
nader1453@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on the quality of life in renal transplant patients referring to Imam reza hospital in Tabriz, 2017-2018
Public title
The effect of self-care education on the quality of life in renal transplant patients referring to Imam reza hospital in Tabriz
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years
Ability to read and write
At least 5 days after kidney transplant ion
The desire to participate in the study
A phone call can be provided for them
No suffering from physical inability and disability, psychiatric illness and other serious chronic diseases that disrupt quality of life like types of cancer or Alzheimer disease
Exclusion criteria:
Lack of more than one session of self-care training sessions
Unwillingness to continue participating in the study
Death and immigration of people
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using the file number and www.random.org website, they were divided into intervention and control groups
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 Urmia University of Medical Sciences
Street address
Orjans Street, Resalat Blvd, Urmia, iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
Ir.umsu.Res.1396.350
Health conditions studied
1
Description of health condition studied
Kidney transplant
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Quality of life score in the questionnaire KTQ-25
Timepoint
Complete the questionnaire before training and two months after the end of the last training session
Method of measurement
questionnaire KTQ-25
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individual face-to-face education with a booklet will be done for 3 sessions with 30 to 45 minutes intervals every two days.The data collection tool KTQ-25 was be completed before and after the intervention, for both groups in Tabriz Imam Reza hospital. The control group will be received routine training. The teaching will be designed and implemented by the researcher in three shifts in the morning, evening and night.The content of the teaching at the first session will be about the nature of the disease, its etiology,Its clinical signs and symptoms, diagnosis and treatment, and complications of the disease. At the second session the principles of drug administration and the side effects of medications will be discussed. During the third session, diet, physical activity and self-care activities will be taught.Two months after the end of the last teaching session, at the time of referral to the clinic or doctor or by telephone, the KTQ-25 questionnaire for patients will be completed again.
Category
Other
2
Description
Control group: No intervention will be in the control group and this group of patients will receive routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Sanaz Jalali
Street address
Gholgasht Ave, Emamreza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7056
Email
emamrezahosp@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Baghaiee
Street address
Pardis nazlu,11km nazlou road
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 0391
Fax
+98 44 4223 2406
Email
rbaghaei2001@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Sanaz jalali
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No43, Baghcheban, Elgoli town, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165949743
Phone
+98 41 3385 6618
Email
Sanaz.j2007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
11km to the road of serve, Nazlou, Faculty of nursing &Midwifery.Urmia
City
urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3275 4963
Email
naderaghakhani2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sanaz jalali
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No43, Baghcheban, Elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5165949743
Phone
+98 41 3385 6618
Email
Sanaz.i2007@gmail.com
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