The purpose of this study is to development and evaluation of an educational - Supportive intervention to improve quality of life in adult patients with thalassemia major. This research is a quasi – experimental and Single blind study. The study population is all adult patients with thalassemia major covered by thalassemia treatment centers of Tehran University of Medical Sciences and Tehran Blood Transfusion Organization. Sample size is 136; 68 in intervention group and 68 in control group. In the pretest, stratified random sampling method will be used. After pretest, subjects will be classified non-randomly to two intervention and control groups. Inclusion criteria: people over 18 years old; consent to participation in the study; no serious problems in physical and mental health. Exclusion criteria: younger than 18 years; the lack of consent to participate in the study; a serious problem in the physical and mental health. Questionnaires included demographic characteristics, quality of life and PRECEDE constructs (Predisposing, Reinforcing and Enabling Constructs) and validity and reliability of the questionnaire will be achieved during the study. In the intervention group, educational interventions to improve quality of life and lifestyle will be implemented. The control group will receive routine educational programs from respective medical institutions. Data extracted from each group, before and 6 months after intervention, will be compared. Primary outcome: improving the quality of life in patients with thalassemia major. Secondary outcome: improving the PRECEDE constructs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111812460N8
Registration date:2016-01-31, 1394/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-31, 1394/11/11
Registrant information
Name
Roya Sadedgi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 327 5692
Email address
sadeghir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Educational vice chancellor of Tehran University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2016-12-31, 1395/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of receiving and not receiving an educational - Supportive intervention on quality of life in adult patients with thalassemia major
Public title
Development and evaluation of an educational - Supportive intervention to improve quality of life in adult patients with thalassemia major
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: people over 18 years old diagnosed with thalassemia major; written and informed consent to participation in the study; no serious problems in physical and mental health. Exclusion criteria: younger than 18 years; the lack of consent to participate in the study; a serious problem in the physical and mental health
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
Main building of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-11-15, 1394/08/24
Ethics committee reference number
IR.TUMS.REC.1394.1153
Health conditions studied
1
Description of health condition studied
Major Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Major Thalassemia
Primary outcomes
1
Description
Quality of life in patients with thalassemia major
Timepoint
Before and six months after the intervention
Method of measurement
Quality of life questionnaire (SF-12)
Secondary outcomes
1
Description
PRECEDE Model constructs
Timepoint
Before and six months after the intervention
Method of measurement
Questionnaire according to PRECEDE Model constructs
Intervention groups
1
Description
In the intervention group, the following measures will be done: holding educational interventions in order to improve quality of life and lifestyle. Type of intervention, intervention of the target groups, educational content, teaching methods, number and timing of training classes, will be determined according to the analysis of the results of the pretest.
Category
Lifestyle
2
Description
There would be no intervention in control group, therefore, the control members will receive routine educational programs from respective medical institutions including: visits by doctor of clinic, vaccinations, blood transfusion, nursing care before, during and after blood transfusion, educating how to use Desferal pump, educating how to iron chelation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zafar Adult Thalassemia Clinic
Full name of responsible person
Dr. Mojtaba Ebrahimi (General Practitioner)
Street address
No 1/1, Corner Shahin Alley, North Mehrdad Nasiri St, Vahid Dastgerdi Av (Zafar), Shariati Av
City
Tehran
2
Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Dr. Seyed Majid Mousavi Movahed (Fellowship / Assistant Professor)
Street address
Behdari Av, Rah Ahan Sq, Tehran
City
Tehran
3
Recruitment center
Name of recruitment center
Ali Asghar Children Hospital
Full name of responsible person
Dr. Elham Talachian (Pediatrician)
Street address
Vahid Dastgerdi Av (Zafar), Shariati Av, Tehran
City
Tehran
4
Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
Dr. Ali Rabbani(Fellowship / Professor)
Street address
No 62, Near Imam Khomeini Hospital Complex, Mohammad Garib Av, Azadi Av, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Educational vice chancellor of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Jalili
Street address
Main Building of Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Educational vice chancellor 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
PhD of Health Education and Promotion / Academic staff
Other areas of specialty/work
Street address
Poorsina Av, Tehran University of Medical Sciences, School of Public Health
City
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Fax
Email
sadeghir@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
PhD of Health Education and Promotion / Academic staff
Other areas of specialty/work
Street address
Poorsina Av, Tehran University of Medical Sciences, School of Public Health
City
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Fax
Email
sadeghir@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
PhD of Health Education and Promotion / Academic staff
Other areas of specialty/work
Street address
Poorsina Av, Tehran University of Medical Sciences, School of Public Health
City
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Fax
Email
sadeghir@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)