Protocol summary

Summary
In this study self-management empowerment model used to evaluate the impact on quality of life in adolescents and youth with major thalassemia. The main inclusion criteria (15 to 25 years old), the main exclusion criteria (sickle thalassemia).The sample size is 70 adolscents & youths with major thalassemia in Bushehr & Borazjan thalassemia clinics.Participants were randomly divided into two case & control groups. The intervention was carried out only in case group. The quality of life and empowering questionnaires was given to both groups. To intervene in the present model to achieve the target, five basic and logic steps is designed. Empowerment model with the concepts of awareness of personal changes, independence, role playing, adaptation, Perceived satisfaction, Being in control, in addition self-management & empowering adolscents with major thalassemia lead to changes in knowledge, attitude and behavior of patients and improve their quality of life. Intervention period is 1.5 months and 3 stages.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013042213092N1
Registration date: 2014-02-03, 1392/11/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-03, 1392/11/14
Registrant information
Name
Maryam Ravanipour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
ravanipour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Bushehr University of Medical Sciences
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Education base on Self-Management Empowering Model On The Quality Of Life In Adolescent and youth With Major Thalassemia
Public title
The Effect Of Education base on Empowering Model On Major Thalassemia Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterias: 15-25 years old patients; HIV-negative; No Mental illness or chronic diseases besides thalassemia. Exclusion criterias: Specific disease during the study period that stop samples; inability to participate in the intervention; Sickle thalassemia patients.
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
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
Research Center of Bushehr University of Medical Sciences
Street address
Pardis Site of Bushehr University of Medical Sciences, Rishehr St, Sabzabad Blvd, Bushehr
City
Bushehr
Postal code
Approval date
2013-12-30, 1392/10/09
Ethics committee reference number
B-92-15-13

Health conditions studied

1

Description of health condition studied
major thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassaemia

Primary outcomes

1

Description
Quality of Life Score
Timepoint
Before intervention & 1.5 months after intervention
Method of measurement
SF-36 Quality of Life questionary

Secondary outcomes

1

Description
Empowering Score
Timepoint
Before intervention & 1.5 months after intervention
Method of measurement
Self-Management Empowerment questioanary

Intervention groups

1

Description
Intervention group: empowerment model, booklet, two section, between 1 week.
Category
Other

2

Description
Control group: routine care, no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr Thalassemia Clinic, Fatemeh Zahra Hospital
Full name of responsible person
Mrs Bashi & Mrs Saghafi
Street address
Bushehr Thalassemia Clinic, Parastar St, Moalem Sq, Bushehr
City
Bushehr

2

Recruitment center
Name of recruitment center
Borazjan Thalassemia Clinic, 17 Shahrivar Hospital,
Full name of responsible person
Mrs Mohammadi & Mrs Bordbar
Street address
17 Shahrivar Sq, Borazjan
City
Borazjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Center of Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostovar
Street address
Research Center of Bushehr University of Medical Sciences,Pardis Site of Bushehr University of Medical Sciences, Rishehr Street, Sabzabad Blvd, Bushehr
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Bushehr 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
The Persian Gulf Tropical Medicine Research Center, Bushehr university of medical sciences
Full name of responsible person
Dr Maryam Ravanipour
Position
MD/MPH, Associate professor
Other areas of specialty/work
Street address
Bushehr, Sangi Street
City
Bushehr
Postal code
Phone
+98 77 1455 0187
Fax
+98 77 1455 0187
Email
ravanipour@bpums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Najmeh Razzazan
Position
MSc Student in Nursing, Student Research Committee
Other areas of specialty/work
Street address
Bushehr
City
Bushehr
Postal code
Phone
Fax
Email
najme.razazan@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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