Determination of the effect of BASNEF-based intervention on quality of life and adherence to treatment in patients with myocardial infarction
Design
This clinical trial has two groups, The groups are parallel, randomized and sample size in each group is 40.
Settings and conduct
As mentioned study population are people with myocardial infarction that selected by simple sampling. The place of intervention is Kashani and Hajar hospitals of Shahrekord. Sample size in each group is 40.The intervention group, a BASNEF-based training program that includes three 45-minute training sessions and a three-month follow-up, will be conducted individually for each of the participants in the group and the control group receives routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from first myocardial infarction؛Lack of mental disorders and mental retardation؛willing to participate in the study؛Ability to read and write Persian language؛Ability to communicate With the research team.Non-inclusion criterion:Unwilling to continue participating in the study؛Creating complications that cause the patient to not be able to continue studying.
Intervention groups
The study consists of two groups. The intervention group receives an educational program based on the BASNEF model and the control group receives routine care.
Main outcome variables
Improve lifestyle; Familiarity with cardiac function and risk factors for the heart; Adherence to controllable factors in the prevention of myocardial infarction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181024041449N4
Registration date:2019-04-22, 1398/02/02
Registration timing:registered_while_recruiting
Last update:2019-04-22, 1398/02/02
Update count:0
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
ali hassanpourdehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 6720
Email address
alihassanpourdehkordi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Intervention based on BASNEF model on Quality of Life and Adherence to Treatment among Myocardial Infarction Patients
Public title
Examining the effect of BASNEF model on patients with myocardial infarction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from first myocardial infarction
Lack of mental disorders and mental retardation
willing to participate in the study
Ability to read and write Persian language
Ability to communicate With the research team
Exclusion criteria:
Unwilling to continue participating in the study
Creating complications that cause the patient to not be able to continue studying.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation; the study participants are divided into two intervention and control groups using a random number table, which is extracted from random statistical software.
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 Shahrkord University Of Medical Sciences
Street address
University Of Medical Sciences, Rahmatie, Shahrkord Town.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.SKUMS.REC.1397.286
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
121.9
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study, immediately after and three months after the intervention
Method of measurement
Ferans and Pavers questionnaire
2
Description
Adherence to treatment
Timepoint
At the beginning of the study, immediately after and three months after the intervention
Method of measurement
Modanlou questionnaire
3
Description
BASNEF pattern structures
Timepoint
At the beginning of the study, immediately after and three months after the intervention
Method of measurement
The adjusted questionnaire based on the structures of the BASNEF model
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group,Educational support based on the BASNEF model consists of three 45-minute training sessions and three-month follow-ups for each of the participants in this group.The location of the sessions will be in the patient's bedside
Category
Treatment - Other
2
Description
Control group: the control group receive treatment and routine care through visiting by his doctor's at office.
Category
N/A
Recruitment centers
1
Recruitment center
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Ali Hassanpour Dehkordi
Street address
ayatollah kashani hospital, nurse ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4826
Email
Kashani@skums.ac.ir
Web page address
http://sapp.ir/kashani_hospital_sh
3
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Ali Hassanpour Dehkordi
Street address
Hajar hospital, nurse ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3222 0016
Email
hajar@skums.ac.ir
Web page address
https://hajarhp.skums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
dr kamal solati
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrkord..
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Alihassanpourdehkordi@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences,Rahmatie,Shahrekord.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
alihassanpourdehkordi@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
alihassanpourdehkordi@skums.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
No - There is not 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