Investigating the effect of peer education on the quality of life of patients with thalassemia major
Design
This study is a randomized clinical trial with a control group and a parallel design. This randomized and non-blinded study will be conducted on at least 96 patients with thalassemia major. A random block is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in Baqai 2 Hospital of Ahvaz, is non-blinded. The intervention group will be divided into 4 groups of 12 people, each group will be taught by a peer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definitive diagnosis of thalassemia major by a doctor; Medical record history; ability to read and write; Willingness to participate in the study; Age above 18 years
Exclusion criteria: Suffering from mental illnesses based on the diagnosis of a psychiatrist; Having a chronic disease such as cancer and...; Cognitive problems and physical disability
Intervention groups
In addition to the routine treatment (training by the doctor, nurse, and posters in the department), the intervention group will receive 2-hour peer training (including lectures, slides, and questions) weekly in 3 training sessions. The control group will receive only routine treatment (education by doctor, nurse, and posters in the department).
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240528061923N1
Registration date:2024-07-12, 1403/04/22
Registration timing:retrospective
Last update:2024-07-12, 1403/04/22
Update count:0
Registration date
2024-07-12, 1403/04/22
Registrant information
Name
Fatemeh Zeinivand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3522 4264
Email address
fatemeh.zeinivand1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-06, 1403/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of peer education on the quality of life of patients with thalassemia major
Public title
The effect of peer education on the quality of life of patients with thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of thalassemia major by a doctor
Having a medical record
Ability to read and write
Willingness to participate in the study
Age above 18 years
Exclusion criteria:
Suffering from mental illnesses based on the diagnosis of a psychiatrist
Having a chronic disease such as cancer and...
Cognitive problems and physical disability
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly, people are divided into two groups of 48 based on random block permutations of 4. The site www.sealedenvelope.com will create random blocks to assign people to groups. In this study, we have two groups, our blocks of 4 can be AABB, ABAB, BABA, BBAA, BAAB, and ABBA, in which A and B represent our groups. Then these six blocks are numbered and placed in the form of the six Blocks that will be sampled. These blocks will then be put together to form our randomization sequence.
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 Ahvaz University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, University city
City
Ahvaz
Province
Fars
Postal code
1579461357
Approval date
2024-05-25, 1403/03/05
Ethics committee reference number
IR.AJUMS.REC.1403.091
Health conditions studied
1
Description of health condition studied
Major thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassemia
Primary outcomes
1
Description
Quality of Life
Timepoint
The beginning of the study and the end of the study
Method of measurement
Based on the quality of life questionnaire (SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
In addition to the routine treatment (training by the doctor, nurse, and posters in the department), the intervention group will receive 2-hour peer training (including lectures, slides, and questions) weekly in 3 training sessions.
Category
Treatment - Other
2
Description
The control group will receive only routine treatment (education by doctor, nurse, and posters in the department).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beqaei Square, At the end of Golestan highway
Full name of responsible person
Fatemeh Zeinivand
Street address
Shahid Beqaei Hospital 2 Ahvaz, Shahid Beqae, At the end of Golestan highwayi Square,
City
اهواز
Province
Fars
Postal code
6138933333
Phone
+98 61 3375 0000
Email
fatemeh.zeinivand1375@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Vice Chancellor for Research Affairs, University city
City
Ahvaz
Province
Fars
Postal code
1579461357
Phone
+98 61 3373 8383
Email
zakerkish-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Neda Sayadi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz University of Medical Sciences, North Esfand, Farvardin St.
City
Ahvaz
Province
Fars
Postal code
6135715794
Phone
+98 61 3314 0000
Email
sayadi-n@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Neda Sayadi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz University of Medical Sciences, North Esfand, Farvardin St.
City
Ahvaz
Province
Fars
Postal code
6135715794
Phone
+98 61 3314 0000
Email
sayadi-n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Neda Sayadi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz University of Medical Sciences, North Esfand, Farvardin St.
City
Ahvaz
Province
Fars
Postal code
6135715794
Phone
+98 61 3314 0000
Email
sayadi-n@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD