Protocol summary
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Study aim
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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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Design
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Two arm parallel group randomized trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Education using application
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Main outcome variables
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Knowledge; adherence rate to diet
General information
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Reason for update
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considering the assessment of gastrointestinal symptoms as a secondary outcome, the "secondary outcome section" is updated.
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Acronym
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IRCT registration information
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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
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Registration date
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2019-06-29, 1398/04/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-06-22, 1398/04/01
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Expected recruitment end date
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2021-06-22, 1400/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Smart phone application for celiac patients
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization using randomization softwares
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-03, 1397/09/12
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Ethics committee reference number
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IR.TBZMED.REC.1397.697
Health conditions studied
1
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Description of health condition studied
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Celiac disease
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ICD-10 code
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K90.0
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ICD-10 code description
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Celiac disease
Primary outcomes
1
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Description
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knowledge
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Timepoint
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At first and 3 months after intervention
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Method of measurement
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Questionnaire
2
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Description
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adherance to diet
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Timepoint
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At first and 3 months after intervention
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Method of measurement
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CDAT questionnaire and serum tTg
Secondary outcomes
1
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Description
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gastrointestinal symptoms
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Timepoint
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Before intervention and 3 months post intervention
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Method of measurement
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using GSRS questionnaire
Intervention groups
1
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Description
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Intervention group: Education with smart phone application
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Category
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Other
2
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Description
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Control group: usual education in clinic
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable