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
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
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032004N2
Registration date:2019-06-29, 1398/04/08
Registration timing:registered_while_recruiting
Last update:2019-06-29, 1398/04/08
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
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
Tabriz University of medical sciencesو 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
empty
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
بیمارستان امام رضا، دانشگاه علوم پزشکی تبریز
Full name of responsible person
زینب نیک نیاز
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