The effect of education based on self-efficacy theory and the theory of self-management and integration of them in order to promote quality of life in kidney transplant recipients
A quasi-experimental design was used to conduct the study which aimed to determine the effect of an educational intervention based on the self-efficacy theory on improving the quality of life for kidney transplant patients. Sample will be selected through a convenience sampling method with random allocation from the nephrology clinic of Imam Hospital of Ardabil. A sample of 115 patients have been estimated using the appropriate sampling formula, given the loss rate of 10%, 130 patients were estimated to include in the study. They will be eligible for this study if they have (1) receivers of kidney transplantation at least 6 months and no longer than 10 years prior, (2) aged at least 18 years old, (3) being in a stable health condition and (4) agreed to participate and to sign the written informed consent form. The questionnaire of quality of life (QoL), self-efficacy scale, self-management scale and psycho-physical stress scales for kidney transplant patients will be used to collect data.
Then intervention based on self-efficacy theory and the theory of self-management and integration of them will be design, and educational content will be prepared. Designed combination intervention will be implemented only on Group 3; for group 1 an educational intervention based on the theory of self-efficacy and for Group 2 an educational intervention based on self-management theory will be done. Follow up assessments will be completed one month and six months after the intervention by the above mentioned questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121931482N1
Registration date:2017-02-09, 1395/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-09, 1395/11/21
Registrant information
Name
Aghil Habibi Soola
Name of organization / entity
Ardabil university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 45 3345 3662
Email address
a.habibi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on self-efficacy theory and the theory of self-management and integration of them in order to promote quality of life in kidney transplant recipients
Public title
self-efficacy, self management and quality of life of kidney transplant patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria;
have received a kidney transplant at least 6 months and no longer than 10 years prior
be at least 18 years old and less than 65 years old
be in a stable Medical condition
Agree to participate
exclusion criteria;
have received a kidney transplant less than 6 months and more than 10 years
be less than 18 years old and more than 65 years old
be in an unstable Medical condition
disagree to participate
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
N/A
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
Ethics committee of Iran University of Medical Science
Street address
Hemmat Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-02-22, 1394/12/03
Ethics committee reference number
IR.IUMS.REC.1394.27236
Health conditions studied
1
Description of health condition studied
kidney transplantation
ICD-10 code
T86.1
ICD-10 code description
Kidney transplant failure and rejection
Primary outcomes
1
Description
self efficacy
Timepoint
pre intervention, one month and six months after intervenyion
Method of measurement
The Kidney Transplantation Self-Care Self-Efficacy Scale
2
Description
self management
Timepoint
pre intervention, one month and six months after intervenyion
Method of measurement
The Kidney Transplantation Self-Management Scale
Secondary outcomes
1
Description
quality of life
Timepoint
pre intervention, one month and six months after intervention
Method of measurement
Short Form Health Survey (SF-36) Questionnaire
2
Description
depression
Timepoint
pre intervention, one month and six months after intervention
Method of measurement
Beck Depression Inventory
Intervention groups
1
Description
Intervention 1;
For group 1, intervention based on self-efficacy theory will be design, and educational content will be prepared and done.
Category
Other
2
Description
Intervention 2;
For Group 2, intervention based on self-management theory will be design and educational content will be prepared and done.
Category
N/A
3
Description
Intervention 3;
For group 3, intervention based on integration of self-efficacy theory and self-management will be design and educational content will be prepared and done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology clinic of Imam Hospital of Ardabil
Full name of responsible person
Vahed Alaee
Street address
Imam Hospital- Ataee street- Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Mrs.Golband
Street address
Hemmat Highway
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, Iran 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
Iran University of Medical Science
Full name of responsible person
Aghil Habibi
Position
PhD student
Other areas of specialty/work
Street address
Department of Health Education and Health Promotion, Faculty of Health, Iran University of Medical Science, Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8670 2543
Fax
Email
a.habibi@arums.ac.ir; aghilhabibi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Mahnaz Solhi
Position
PhD of Health education & Health promotion
Other areas of specialty/work
Street address
Department of Health Education and Health Promotion, Faculty of Health, Iran University of Medical Science, Hemmat Highway.
City
Tehran
Postal code
Phone
+98 21 8670 4756
Fax
Email
solhi.m@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Aghil Habibi
Position
PhD student
Other areas of specialty/work
Street address
Department of Health Education and Health Promotion, Faculty of Health, Iran University of Medical Science, Hemmat Highway
City
Tehran
Postal code
Phone
+92 1867 02543
Fax
Email
A.habibi@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)