Protocol summary

Summary
This research will do with the purpose of comparison of self-care education based on short message service and pamphlet on self-efficacy and adherence to the medication regimen in adolescents with epilepsy referring to Iranian Association of Epilepsy.In other words, the main purpose is familiar young people with epilepsy supportive care.This study was a randomized clinical trial with control group.The samples (n=90) are adolescents in the age range 12 to 18 years who register in Iranian Epilepsy Association.We can point to two main inclusion criteria: 1) Doctor should diagnose epilepsy in adolescents. 2) Adolescents or their parents should have access mobile phones and the ability to use short message service. This clinical-trial study was done on 90 Epilepsy patients who were divided into two cases and one control groups. Intervention is self-care education program based on short message service and pamphlet.In pamphlet group,five educational pamphlet will be given to patients about the self-care in regular separated time in 3 months.In this pamphlet we train to patients about sleeping, taking the exact dose of medicine , knowing the exact time for taking medicine, Side effects of medications, continuation of medicine, not to take other medicine without checking your doctor,avoidance of stimuli and stress, doing exercises and activities.in SMS method, we will send 48 sms every 4 weeks for 3 months with a focus on discussion pamphlet.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015060122514N1
Registration date: 2015-10-27, 1394/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Rezvan Kazemi Majd
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 4137
Email address
re.kazemimajd@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental.University of Social Welfare and Rehabilitation
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of self-care education based on short message service and pamphlet on self-efficacy and adherence to the medication regimen in adolescents with epilepsy
Public title
The effect of self-care education based on short message service in adolescents with epilepsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion: 1) Doctor should diagnose epilepsy in adolescents 2) Adolescents should be in the age range 12 to 18 years 3) Adolescents should be a member of the Epilepsy Society 4) Adolescents or their parents should have access mobile phones and the ability to use short message service. 5) Adolescents should be literate. 6) Adolescents shouldn’t have any mental and physical diseases. 7) Adolescents should take an anti-seizure medication for at least 6 months. Exclusion: 1) The risk of physical and psychological problems that prevent them to continuing in the study. 2) If participants don’t complete questionnaires or do not wish to continue the cooperation of researchers, so they will removed samples.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
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
University of Social Welfare and Rehabilitation
Street address
Kudkyar dead end , Daneshjoo boulevard, Evin street Tehran
City
Tehran
Postal code
1985713834
Approval date
2015-04-30, 1394/02/10
Ethics committee reference number
IR.uswr.Rec.1394.143

Health conditions studied

1

Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy

Primary outcomes

1

Description
Self efficacy
Timepoint
Befor intervention and 3 month after intervention
Method of measurement
Epilepsy Self-Efficacy Scale-33 Items questionnaire

2

Description
Adherence to the medication regimen
Timepoint
Befor intervention and 3 month after intervention
Method of measurement
Eight Items Morisky Medication Adherence Scale(MMAS-8)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention is self-care education program based on short message service and pamphlet.In pamphlet group,five educational pamphlet will be given to patients about self-care in regular separate time in 3 months.In this pamphlets we train to patients about sleeping, taking the exact dose of medicine , knowing the exact time for taking medicine, Side effects of medications, continuation of medicine,not to take other medicine without checking your doctor,avoidance of stimuli and stress, exercises and activities.
Category
Lifestyle

2

Description
in SMS method, we will send 48 sms every 4 weeks for 3 months with a focus on discussion workshops.
Category
Lifestyle

3

Description
control group: did not receive any training.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Epilepsy Association
Full name of responsible person
Street address
Tehran-Sharyati street-under the Seyed Khandan bridge-
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohammad ali hoseini
Street address
Kudkyar dead end , Daneshjoo boulevard, Evin street Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohammad ali hoseini
Position
PHD
Other areas of specialty/work
Street address
Kudkyar dead end , Daneshjoo boulevard, Evin street Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0132
Fax
Email
mahmaimy2020@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohammad ali hoseini
Position
PHD
Other areas of specialty/work
Street address
Kudkyar dead end , Daneshjoo boulevard, Evin street Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0132
Fax
Email
mahmaimy2020@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Rezvan Kazemi majd
Position
student
Other areas of specialty/work
Street address
Kudkyar dead end , Daneshjoo boulevard, Evin street Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
re.kazemimajd@uswr.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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