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Designing a smart phone application for celiac patients and evaluate the effect of this application on patients knowledge and the rate of adherence to gluten free diet compared with conventional education in clinic

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History
# Registration date Revision Id
2 2020-06-21, 1399/04/01 139933
1 2019-06-29, 1398/04/08 95078
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  • General information

    empty
    considering the assessment of gastrointestinal symptoms as a secondary outcome, the "secondary outcome section" is updated.
    empty
    با توجه به اینکه در این مطالعه علائم گوارشی به عنوان پیامد ثانویه سنجیده شده اند، بخش پیامد ثانویه آپدیت شد.

  • Secondary outcomes

    #1
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    gastrointestinal symptoms
    empty
    علائم گوارشی
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    Before intervention and 3 months post intervention
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    قبل از مداخله و 3 ماه بعد از مداخله
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    using GSRS questionnaire
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    با استفاده از پرسشنامه GSRS

  • Recruitment centers

    #1
    Name of recruitment center - English: بیمارستان امام رضا، دانشگاه علوم پزشکی تبریز
    Name of recruitment center - Persian: Imam Reza Hospital, Tabriz University of medical sciences
    Full name of responsible person - English: زینب نیک نیاز
    Full name of responsible person - Persian: Zeinab Nikniaz
    Street address - English: Golgasht St, Imam Reza Hospital
    Street address - Persian: خیابان گلگشت، بیمارستان امام رضا
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614756
    Phone: +98 41 3335 1688
    Fax:
    Email: znikniaz@hotmail.com
    Web page address:
    Name of recruitment center - English: Imam Reza Hospital, Tabriz University of medical sciences
    Name of recruitment center - Persian: بیمارستان امام رضا، دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Zeinab Nikniaz
    Full name of responsible person - Persian: زینب نیک نیاز
    Street address - English: Golgasht St, Imam Reza Hospital
    Street address - Persian: Imam Reza Hospital, Golgasht St,
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614756
    Phone: +98 41 3335 1688
    Fax:
    Email: znikniaz@hotmail.com
    Web page address:

Protocol summary

Study aim
Designing a smart phone application for celiac patients and evaluate the effect of this application on patients knowledge and the rate of adherence to gluten free diet compared with conventional education in clinic
Design
Two arm parallel group randomized trial
Settings and conduct
Target population in the present study is adults with celiac disease in Tabriz. At first an application will be designed and its reliability and validity will be checked using 10 expert panel and also 10 patients. Then the patients will divided two groups; one group will received regular education in clinic plus application, the second group will only receive education in clinic. after 3 months patients knowledge (using questionnaire) and also their adherence to gluten free diet (using CDAT and serum tTG) will be evaluated.
Participants/Inclusion and exclusion criteria
Being as a member of celiac association; biopsy proven celiac patients; aged >18 years old; educated and can use phone application. Exclusion criterion: disease that affect study outcomes.
Intervention groups
Education using application
Main outcome variables
Knowledge; adherence rate to diet

General information

Reason for update
considering the assessment of gastrointestinal symptoms as a secondary outcome, the "secondary outcome section" is updated.
Acronym
IRCT registration information
IRCT registration number: IRCT20170117032004N2
Registration date: 2019-06-29, 1398/04/08
Registration timing: registered_while_recruiting

Last update: 2020-06-21, 1399/04/01
Update count: 1
Registration date
2019-06-29, 1398/04/08
Registrant information
Name
Zeinab Nikniaz
Name of organization / entity
Liver and gastrointestinal disease research center, Tabriz University of medical sciences-Tabriz_Ir
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 7473
Email address
nikniazz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing a smart phone application for celiac patients and evaluate the effect of this application on patients knowledge and the rate of adherence to gluten free diet compared with conventional education in clinic
Public title
Smart phone application for celiac patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being as a member of celiac association, , Biopsy proven celiac patients Aged>18 years old Educated and can use phone application
Exclusion criteria:
Disease that affect study outcomes
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using randomization softwares
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.TBZMED.REC.1397.697

Health conditions studied

1

Description of health condition studied
Celiac disease
ICD-10 code
K90.0
ICD-10 code description
Celiac disease

Primary outcomes

1

Description
knowledge
Timepoint
At first and 3 months after intervention
Method of measurement
Questionnaire

2

Description
adherance to diet
Timepoint
At first and 3 months after intervention
Method of measurement
CDAT questionnaire and serum tTg

Secondary outcomes

1

Description
gastrointestinal symptoms
Timepoint
Before intervention and 3 months post intervention
Method of measurement
using GSRS questionnaire

Intervention groups

1

Description
Intervention group: Education with smart phone application
Category
Other

2

Description
Control group: usual education in clinic
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz University of medical sciences
Full name of responsible person
Zeinab Nikniaz
Street address
Golgasht St, Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 1688
Email
znikniaz@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golgasht St. Tabriz University of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 1688
Email
znikniaz@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Nikniaz
Position
Assistant proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Tabriz University of medical sciences,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 1688
Email
znikniaz@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Nikniaz
Position
Assistant peoffessor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza hospital, Tabriz University of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 40 3335 1688
Email
znikniaz@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Nikniaz
Position
Assistant proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza hosptal, Tabriz University of medical sicnecess
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 1688
Email
znikniaz@hotmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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