Determining the Effect of Cognitive-Behavioral Intervention on the Diet of Cardiovascular Patients.
Design
Samples are selected according to entry research criteria.
Then, by using randomization, the minimization method is based on the age and frequency of the feed frequency questionnaire in each of the two control groups. In this method, the first samples are randomly assigned to one of the groups, and for the subsequent samples to be collected in each of the group Attention is drawn and the sample is assigned to a group that has a smaller amount.
Settings and conduct
Patients admitted to the CCU ward of Ali Ebn Abi Talib (A) Hospital in Rafsanjan
Cognitive-behavioral intervention adherence to the diet of patients is done in 4 sessions.
Participants/Inclusion and exclusion criteria
the participant satisfaction in the study.
No history of mental disorders.
Lack of patient participation in other research
Earn less than 50 percent of the total score of the Questionnaire.
Cardiovascular disease and diagnosis of ischemic heart disease.
Intervention groups
At first, the score of the questionnaire is determined by the frequency of patients' feed. The cause of the non-compliance of the patient's diet in the intervention group is determined.
Cognitive-behavioral intervention is given to patients by using existing knowledge and face-to-face training
There is no intervention in the control group
Main outcome variables
Average score diet food frequency questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171002036498N2
Registration date:2018-10-24, 1397/08/02
Registration timing:retrospective
Last update:2018-10-24, 1397/08/02
Update count:0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
Ali Akbari
Name of organization / entity
Medical Sciences of Rafsanjan University
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
iccn@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-24, 1396/12/05
Expected recruitment end date
2018-09-27, 1397/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of cognitive-behavioral intervention on diet imitation in heart ischemic patients
Public title
Investigation the effect of cognitive-behavioral intervention on diet imitation in heart ischemic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Cardiovascular disease and diagnosis of ischemic heart disease.
Earn less than 50 percent of the total score of the Frequency Questionnaire.
Lack of patient participation in other research projects along with this plan
No history of mental disorders.
Satisfaction to participate in the study
Exclusion criteria:
Unwillingness to continue the plan.The patient's
admission to the acute stages of the disease.
Lack of access to patients for a one-month follow-up.
Not attending a sample at a training session.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected based on entry criteria and available method
Then, by using randomization, the classification based on the age and frequency of the frequency of the questionnaire on the frequency of food in each of the two groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Ali-ebn-abitaleb blvd.
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.RUMS.REC.1397.024
Health conditions studied
1
Description of health condition studied
Diet
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean Score of Diet in the Frequency food Questionnaire
Timepoint
Determine the frequency of the feed frequency questionnaire before and after the intervention
Method of measurement
food frequency questionnaire
Secondary outcomes
1
Description
Modify the diet
Timepoint
before and after intervention
Method of measurement
Food Frequency Questionnaire
Intervention groups
1
Description
"Intervention group: heart ischemic patients receiving behavioral behavioral diet training received face-to-face."
Category
Behavior
2
Description
"Control group:heart Ischemic patients who did not receive any intervention."
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebn-Abitaleb hospital
Full name of responsible person
Khodadadi Ali
Street address
Emam Ali Blvd. Ali-Ebn-Abitalib Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0001
Email
Karimielham913@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shamsizadeh Ali
Street address
Medical Sciences University, Ali-Ebn-Abitaleb.Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
iccn@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
KHodadadi Ali
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rafsanjan univesity of nursing ParastarBlv,Motahari Ave
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Email
iccn@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
KHodadadi Ali
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rafsanjan university of nursing,Parastar Blv,Motahari Ave
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34255900
Email
iccn@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Akbari Ali
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rafsanjan university of nursing,Parastar Blv,Motahari Ave
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34255900
Email
iccn@rums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available