Protocol summary

Summary
This is a clinical trial that investigate the effect of e-learning self-care on self concept of adolescents with diabetes referred to the Iranian Diabetes Society in 1390. The study sample included 80 adolescents aged 11-19 with diabetes referred to the Diabetes Association of Iran having entry criteria They have no other chronic illness such as asthma; epilepsy; mental retardation; severe mental disorders; learning and memory disorders; and any disorders that interfere with patient cooperation; Adolescents not participate in similar research. Unwillingness to continue participation in intervention research; Changes in the course of the disease condition (hospitalization) Were excluded. Getting written consent were enrolled. The control group received routine education according to Iranian Diabetes Society program for 15 hours. Experience group received e-learning self care education beside routine education. To review the effectiveness of education on adolescent self concept, last level of blood sugar have assessed. Also, self concept of them were measured by Piers Harris questionnaire and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104246274N1
Registration date: 2011-06-18, 1390/03/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-18, 1390/03/28
Registrant information
Name
Maryam Rahmati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 216697171
Email address
mrahmati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-12-13, 1389/09/22
Expected recruitment end date
2011-04-19, 1390/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Compare of e-learning and Routine self-care on self concept of adolescents with diabetes referred to the Iranian Diabetes Society in 1390
Public title
Effect of e-learning self-care on self concept of adolescents with diabetes referred to the Iranian Diabetes Society in 1390
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: They have no other chronic illness such as asthma; epilepsy; mental retardation; severe mental disorders; learning and memory disorders; and any disorders that interfere with patient cooperation; Adolescents not participate in similar research; Have minimum education level of reading and writing; Have definite diagnosis of diabetes and at least six months history of diagnosis; Have 11-19 years old; accessible to CD or DVD player and how to use it by the individual or family is possible; Accept their disease and not deny it. Exclusion criteria: Unwillingness to continue participation in intervention research; Changes in the course of the disease condition (hospitalization).
Age
From 11 years old to 19 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethical Review Commiitee of Tehran University of Medical Sciences
Street address
Keshavarz BLD, Ghods street, Central building of Tehran University of Medical Sciences, 6th floor
City
Tehran
Postal code
Approval date
2010-12-12, 1389/09/21
Ethics committee reference number
1121/130/د/89

Health conditions studied

1

Description of health condition studied
Diabetes type 1
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
self concept:Imagine a person with his own deliberate
Timepoint
before and 4 weeks after intervention
Method of measurement
piers hariss questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
experience group also received routine education and e-learning self care education that designed by researcher for 4 weeks and after 4 week self concept questionnaire were completed.
Category
Other

2

Description
Control group received routine education according to Diabetes Association program for 15-hours
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Diabetes Association
Full name of responsible person
Mr. Rezaei
Street address
No. 27, Ramin malekoti st, patris lomomba st, satarkhan st.
City
Tehran

2

Recruitment center
Name of recruitment center
Rajab's Doctor Office
Full name of responsible person
Miss Taleghani
Street address
No 10. fereshteh st. satarkhan st. touhid squre.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Scinces
Full name of responsible person
Abbas Hoshmand Behabadi
Street address
Nosrat ST.Tohid SQ, Faculty of Nursing and Midwifery
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, Tehran University of Medical Scinces
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 Siences
Full name of responsible person
Arezoo Fathi
Position
Nursing student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat St, Tohid Sq
City
Tehran
Postal code
Phone
+98 989188750154
Fax
Email
ailin_arbaba_s@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Maryam Rahmati
Position
Instructor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat ST,Tohid Sq
City
Tehran
Postal code
Phone
+98 912 335 8973
Fax
Email
mrahmati@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Maryam Rahmati
Position
Instructor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat ST,Tohid Sq
City
Tehran
Postal code
Phone
+98 912 335 8973
Fax
Email
mrahmati@tums.ac.ir
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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