main objective
The Effect of Nursing Counseling on Knowledge and Practice in Adherence to the Diet of Patients with Celiac Disease
Design
Clinical trials with control group, with parallel groups, one-on-one blind, randomized
Settings and conduct
The Celiac Community Center of Isfahan
In this study, the outcome assessor was kept blind to randomized
appropriation, either parallel or single-blind design.
Participants/Inclusion and exclusion criteria
The Desire to Participate in the Study
Individuals Diagnosed with Celiac Disease by Gastroenterologist and Confirmed by Biopsy and Blood Positive Serology Test
People Who have been Gluten-Free Diet for more than 6 Months
People Over 18 Years of Age
Disinclination to Continue to Participate in Research
Intervention groups
(Intervention group)) to Nursing Counseling and (Control Group) based on the
Celiac Center Routine Care
The Effect of Nursing Counseling on knowledge and Practice Dietary Compliance in Patients with Celiac Disease
Public title
The Effect of Nursing Counseling on knowledge and Practice Dietary Compliance in Patients with Celiac Disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The Desire to Participate in the Study
Individuals Diagnosed with Celiac Disease by Gastroenterologist and Confirmed by Biopsy and Blood Positive Serology Test
People Who have been Gluten-Free Diet for more than 6 Months
People Over 18 Years of Age
Exclusion criteria:
Disinclination to Continue to Participate in Research
In this study, the outcome assessor was kept blind to randomized appropriation, either parallel or single-blind design.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Islamic Azad University (Khorasgan)
Street address
Islamic Azad University, Isfahan Branch (Khorasgan), University Blvd, Arghavaniyeh, East Jey St.
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.153
Health conditions studied
1
Description of health condition studied
Celiac disease
ICD-10 code
K55-K63
ICD-10 code description
A chronic Intestinal discomfort associated with malabsorption due to gluten intolerance.
Primary outcomes
1
Description
Level of knowledge in Dietary Compliance in Patients with Celiac Disease
Timepoint
Before starting the study and 5, 8, 10 weeks after the nursing consultation
Method of measurement
Dietary Compliance about knowledge Questionnaire (Researcher)
2
Description
Level of Practice in Dietary Compliance in Patients with Celiac Disease
Timepoint
Before starting the study and 5, 8, 10 weeks after the nursing consultation
Method of measurement
Dietary Compliance about Practice Questionnaire (Researcher)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 49 patients were interviewed by nursing counseling method in the form of seven, verbally and face-to-face groups in the Celiac Center. Two weeks after the intervention sessions, a supplementary counseling session was organized to assess possible dietary problems Became Then one week after the supplementary counseling session, the questionnaires were filled out by knowledge and practice by telephone and in person by him and supervised by a research colleague who did not know the type of study group.
Category
Behavior
2
Description
Control group :(50 patients) were studied based on routine care of the association.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Celiac Community Center and Poursina Hakim Gastrointestinal Diseases Research Center
Full name of responsible person
Tahere Karimi
Street address
Third Floor,Noor Integrated, North Ordibehesht St,Taleghani St.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Tahere karimi
Position
Master of Science in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan Branch (Khorasgan), University Blvd., Arghavaniyeh, East Jey St.
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31353540019
Fax
+98 31 3535 4060
Email
karimitahere63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh Ziaeirad
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan Branch (Khorasgan), University Blvd., Arghavaniyeh, East Jey St.
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31353540019
Fax
+98 31 3535 4060
Email
mziaeirad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahere karimi
Position
Master of Science in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pediatric Department,Dr Ali Shariati Hospital,Shariati St
City
Esfahan
Province
Isfehan
Postal code
81737-45384
Phone
+98 31362720014
Email
karimitahere63@GMAIL.COM
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only the Original outcome Can be Shared. The Main Consequence of my Study is Adherence of Gluten-free diet in two Groups of Test and Control, and Only the Difference Outcome is Reported in the two Groups.
When the data will become available and for how long
The article in the journal is available within 1 month.
To whom data/document is available
Only Available Working Scholars in َAcademic Institutions
Under which criteria data/document could be used
Due to the fact that ownership of the data with the Association, Celiac Special Clinic and Islamic Azad University of Isfahan (Khorasgan) is not possible to transfer data to other research groups.
From where data/document is obtainable
Poursina Hakim Gastrointestinal Diseases Research Center, Poursina Hakim Clinic,Third Floor,Phase I, Health Center, Sepehr Blvd, AghaBabaee Road, Isfahan.
What processes are involved for a request to access data/document
Step 1: Visit the site of the Iranian Celiac Association or Poursina Hakim Research Center or by visiting the relevant research expert.
Step Two: Contract Collaboration
Step 3: Operate the data under the supervision of these centers