The Effect of Continuous Care Model on General Health in Kidney Donors
Design
This study is a one-blinded clinical trial. The research population will include donors of all patients referred to hospitals in Isfahan. 72 eligible patients will be selected by available means and randomly assigned to intervention and control groups.
Settings and conduct
This study that will be conducted in Isfahan hospitals is a one-blinded one.In this way, the participants did not know about the follow-up care and how to take care of the other participants.At the beginning of the study, a general health questionnaire will be provided to the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Donors must have the minimum literacy (fifth grade of elementary school, and higher); Being vigilant (conscious); Dont having eye and ear diseases preventing communication; Donors must be willing to participate in the study
Exclusion criteria: History of mental disorder
Intervention groups
The intervention group during the familiarization phase (30 to 45 minutes) and the sensitization phase will be followed up on a weekly basis for 3 weeks by telephone. They will then be monitored and evaluated weekly by telephone for 3 months. The control group will not receive any intervention.
Main outcome variables
General health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200818048449N1
Registration date:2020-10-10, 1399/07/19
Registration timing:retrospective
Last update:2020-10-10, 1399/07/19
Update count:0
Registration date
2020-10-10, 1399/07/19
Registrant information
Name
Sadigheh Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3470 4547
Email address
ali56ali86@chmail.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-16, 1399/07/25
Expected recruitment end date
2020-11-25, 1399/09/05
Actual recruitment start date
2019-06-27, 1398/04/06
Actual recruitment end date
2020-08-27, 1399/06/06
Trial completion date
2020-09-23, 1399/07/02
Scientific title
The Effect of Continuous Care Model on General Health in Kidney Donors
Public title
The Effect of Continuous Care Model on General Health in Kidney Donors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Donors must have the minimum literacy (fifth grade of elementary school, and higher)
Being vigilant (conscious)
Do not have eye and ear diseases preventing communication
Donors must be willing to participate in the study
Exclusion criteria:
History of mental disorder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
Using a block randomization method. In this study, the blocks are selected weekly, so that, the intervention group will be evaluated in the first week, and in the second week the control group will be evaluated randomly. This method will continue until the required number of samples will be obtained. To avoid bias, the start of sampling in each week will be subject to the clearance of all survey units in the last week.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants / that they did not know about follow-up care and how to care for the rest of the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Khorasgan Branch
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8198818139
Approval date
2020-06-14, 1399/03/25
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.053
Health conditions studied
1
Description of health condition studied
General health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
General health
Timepoint
Beginning of study, the third week, the third month
Method of measurement
Standard 28-Questions General Health Questionnaire (Goldberg 2009)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group during the familiarization phase (30 to 45 minutes) and the sensitization phase will be followed up on a weekly basis for 3 weeks by telephone.They will then be monitored and evaluated weekly by telephone for 3 months
Category
Other
2
Description
The control group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Hospital
Full name of responsible person
Maryam Radmehr
Street address
Unit 3, No. 123, Chitsaz Alley, Sheikh Tusi Gharbi St., Parvin St.
City
Isfahan
Province
Isfehan
Postal code
8198818139
Phone
+98 31 3470 4547
Email
ali56ali86@chmail.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mohammad Roholah Yazdani
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.yazdani@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Sedihgeh Esmaeili
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
ali56ali86@chmail.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Radmehr
Position
Faculty member of Islamic Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
Maryam.Radmehr۳۱۳۲@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sedigheh Esmaili
Position
Master of Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
ali56ali86@chmail.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Just part of the data like the information related to original outcome
When the data will become available and for how long
Access period will be started six months after the results are published
To whom data/document is available
The data will be only accessed by the researchers working in academic and scientific institutions.Will be available
Under which criteria data/document could be used
The data will be only accessed by the researchers working in academic and scientific institutions.Will be available
From where data/document is obtainable
ali56ali86@chmail.ir
What processes are involved for a request to access data/document
After obtaining permission from the supervisor, the data will be sent by email.