The aim of this study was to evaluate the effect of treatment with prescription information, to inflammatory bowel disease.The sample size was 160 patients with inflammatory bowel disease who were referred to a hospital clinic of Imam Reza (AS) Tabriz, during a visit of the first Persian date Mordad 1394 to 1395 is the first pole of the year.Random sampling will be carried out.The study will be a blinded.Blind will also evaluate the data.Evidence-based information regarding the current situation of the patient to his doctor prescribes,Prepared by an expert librarian And after assessments and simplify it in terms of intelligibility For patients in a printed format in writing to the intervention group and the oral explanation provided.But groups control only receive oral information in accordance with the usual procedure.The implications of this study are:The effect of therapeutic intervention in reducing relapses, the effect of therapeutic intervention in health care costs;The effect of therapeutic intervention in the frequency of complications of hypochondriasis after the release of health information, the effect of therapeutic intervention in the reduction of drug and dosage, the effect of therapeutic intervention in inflammatory bowel disease, quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510137612N2
Registration date:2016-05-24, 1395/03/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-24, 1395/03/04
Registrant information
Name
Vahideh Zarea Gavgani
Name of organization / entity
Medical Science of Tabriz University
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 6915
Email address
zarehv@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences - Research Department
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to study the effect of information prescription in reducing relaps among patients with inflammatory bowel disease
Public title
The Effect of information therapy prescribed by physician to reduce relaps in patients with inflammatory bowel disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with inflammatory bowel disease; literate (minimum cycle) or at least the carer to be literate. Consciousness,no acceess to information other than intervention such as family members. Age between 18 to 85 years, consent to participate in the study.Exclusion criteria: Prior knowledge and informed: Patients who already have other sources of information other than the version information Such as having access to a doctor in the family, or close friends in that case, patients should be excluded;Lack of awareness;Chronic digestive diseases other than that for which the drugs.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Tabriz University of Medical Sciences
Street address
Tabriz, GOLGASHT, University Avenue, University of Medical Sciences
City
Tabriz
Postal code
5166615739
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
TBZMED.REC.1394.355
Health conditions studied
1
Description of health condition studied
Inflammatory bowel disease
ICD-10 code
K50
ICD-10 code description
Crohn disease [regional enteritis]
2
Description of health condition studied
Inflammatory bowel disease
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Reduction of relapses
Timepoint
Two and four months after intervention
Method of measurement
Phone calls and questionnaires
Secondary outcomes
1
Description
medical expenses
Timepoint
Two and four months after intervention
Method of measurement
Call-questionnaire
2
Description
Frequency of complications Hypochondrias
Timepoint
Two and four months after intervention
Method of measurement
Call-questionnaire
3
Description
Change in the number of drugs and dose of intake
Timepoint
Two and four months after intervention
Method of measurement
Call-questionnaire
4
Description
Quality of life
Timepoint
Two and four months after intervention
Method of measurement
Call-questionnaire
Intervention groups
1
Description
In this study, the type of intervention in the form of a written copy of the information prescribed by a doctor.Patients in the intervention group in addition to the usual information that is given to patients. Treatment with oral prescription information to librarians about the information they receive. Information content includes information about inflammatory bowel disease, medications, tests, symptoms, exercise and self-care is health.The control group did not receive written information and oral librarian.
Category
Prevention
2
Description
Patients in control group only received verbal information typically provided by your doctor, and the doctor does not receive health information.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mohammad Hossein Somi
Street address
Tabriz, GOLGASHT, Imam Reza Hospital
City
Tabriz
2
Recruitment center
Name of recruitment center
Sheikh Alrys clinic affiliated with the University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Somi
Street address
Tabriz, Liberty Avenue, not far from the GOLGASHT, Avicenna Clinic
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences Research Council
Full name of responsible person
Dr. Mohammad Reza Rashidi, Deputy Director for Research
Street address
Tabriz, GOLGASHT, University Avenue, University of Medical Sciences
City
Tabriz
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 Research Council
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
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Akbari Aykdh Lu
Position
A graduate student in Library and Information Science Medicine
Other areas of specialty/work
Street address
Tabriz, GOLGASHT, Street University, Faculty of management and medical informatics
City
Tabriz
Postal code
Phone
+98 910 408 0053
Fax
Email
parisa.akbari68@yahoo.comredflower0053@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr. Vahideh Zarea Gavgani
Position
Associate professor of medical library and information sciences
Other areas of specialty/work
Street address
GOLGASHT, Street University, Faculty of Management and Information Sciences, room 405 b. Tabriz University of Medical Sciences