Clinical trial Comparing the effectiveness of educational- supportive program on quality of life and transplant acute complications in two groups of kidney transplant patients.
This study is done to the investigate effect of educational supportive package on quality of life and transplant acute complications in kidney transplant patients. This study is quasi-experimental, non-randomized, available sample method, sample volume 72 person( each group 36 person). Patients with age of 18 to 60 years and ability of read and write can participate in study and they are omitted from the study upon appearance of transplant acute complications and prolonged hospitalization. By drawing lots between the two hospitals where the research is conducted, one place is allocated to test group and other to control group. On reaching the semi- study, for create equal conditions, groups study place is replaced. By obtaining a written consent indicating voluntary participation and prior to commencement of intervention, demographic and disease questionnaire and kidney transplant specific questionnaire is completed by two groups. Educational supportive package contains 5 educational meetings 20 to 30 minutes based on care issues, stress decrease methods and matching with conditions, after relative recovery and during hospitalization period is conducted by the researcher through face to face method.The guidebook and 5 to 10 minute telephone contacts for responding to the patient's questions are included in this program. Control group receives routine training and cares of the ward. 8 weeks after the commencement of intervention, the quality of life specific questionnaire is completed by the patient and researcher made checklist for transplant acute complications is completed by the researcher in two groups and then, they are compared by using statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607254443N21
Registration date:2017-06-21, 1396/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran university of medical sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial Comparing the effectiveness of educational- supportive program on quality of life and transplant acute complications in two groups of kidney transplant patients.
Public title
Effect of education and supportive on quality of life and transplant acute complications in kidney transplant patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18-60 year; least ability to read and write; interest to participate in study; the first transplant is done in patient; the patient is not member of treatment team; no history of mental disease. Exclusion criteria: hyper acute transplant complications; staying over 20 days in hospital.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Ghods street, Keshvarz boulevard
City
Tehran
Postal code
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR-TUMS-VCR- REC-1395-189؛ Ethics committee of Tehran university of medical sciences
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
Timepoint
Before and 8 weeks after intervention start
Method of measurement
Quality of Life specific questionnaire in kidney transplant patients(KTQ-25)
Secondary outcomes
1
Description
Kidney transplant acute complications
Timepoint
8 weeks after intervention start
Method of measurement
Kidney transplant acute complications check list
Intervention groups
1
Description
In test group, interventions are as follows: face to face educational meetings is in five times 20 to 30 minutes. In this meetings is discussed on the patient's condition and the chronic nature of disease. Need to permanent care and follow-up, medicinal regime and diet importance in maintaining health and survival of transplanted kidney, understanding the risks and symptoms of rejection, new style of life and how to deal with common issues is discussed. Express fears and worry and respond to their questions take place in this meetings. Stress decrease methods such as listening to favorite music, thinking distraction by using favorite pastime and draw attention to issues other than illness, relaxation and relax the muscles and chants calming and all matching methods with this conditions is in educational supportive program. The guidebook which contains the necessary care points is given to the patients upon discharge and 5 to 10 minute telephone contacts are included in this program on a weekly basis during 8 weeks( by emphasizing the necessary care points and responding to the patient's questions).
Category
Other
2
Description
In control group no intervention is conducted by researcher and patients receive routine training and cares of the ward.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imamkhomeini hospital, Kidney transplant ward
Full name of responsible person
Zakerimoqhadam Masoumeh
Street address
Eastern Nosrat street, Tohid square
City
Tehran
2
Recruitment center
Name of recruitment center
Shariati hospital- Kidney transplant ward
Full name of responsible person
Zakerimoqhadam masoumeh
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran university of medical sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Street address
Eastern Nosrat street, Tohid square
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 of Tehran 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
Nursing midwifery faculty of Tehran university of medical sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Nursing education PHD, Faculty member
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address
Fnm.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical Sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Nursing education PHD، Faculty member
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 66927171
Fax
+98 21 6690 4252
Email
zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address
fnm.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical Sciences
Full name of responsible person
Zakeromoghadam Masoumeh
Position
Nursing education PHD, Faculty member
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address
fnm.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)