Determining the effectiveness of cardiac rehabilitation program at home based on the "health action process approach" in patients with myocardial infarction
Design
A randomized controlled clinical trial on 136 patients
Settings and conduct
The intervention group receives a home-based cardiac rehabilitation program under the Android application based on the "health action process approach" for 8 weeks, and the control group receives the usual cardiac rehabilitation programs in the center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with myocardial infarction with any diagnosis and treatment.
exclusion criteria: not being satisfied with the program
Intervention groups
Intervention group: Home-based cardiac rehabilitation group
Control group: usual cardiac rehabilitation program in the center
Evaluation and designing a home-based cardiac rehabilitation in myocardial infarction patient based on health action process approach
Public title
Evaluation a home based cardiac rehabilitation in myocardial infarction patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with myocardial infarction with any diagnosis and treatment
High risk people with a doctor's diagnosis
Having a license from your doctor to participate in a cardiac rehabilitation program at home
Having a mobile phone or tablet (Android) to receive the application (patient or a family member living with her)
Willingness to participate in the study
Have a minimum literacy
Exclusion criteria:
Mental dysfunction
Musculoskeletal Disorder
Lack of application and discontinue programs in the educational process
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization unit is individual and patients are randomly assigned to one of the two intervention and control groups by permutation blocks (each block with a volume of 2).
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 Isfahan University of Medical Sciences
Street address
Hezar Jerib St., East Door of Isfahan University, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.755
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Physical activity score in IPAQ
Timepoint
Before,3 and 6 months after the intervention
Method of measurement
IPAQ Physical Activity Questionnaire
2
Description
Functional capacity score
Timepoint
Before and 6 months after the intervention
Method of measurement
6 minute walk test
3
Description
Endothelial function of the heart
Timepoint
Before and 6 months after the intervention
Method of measurement
Flow mediated dilation
Secondary outcomes
1
Description
Anxiety and depression score
Timepoint
Before and 6 after the intervention
Method of measurement
Standard Anxiety and Depression Inventory (HADS)
Intervention groups
1
Description
Intervention group: This group receives a home-based cardiac rehabilitation program under the Android application based on the health action process approach for 8 weeks.
Category
Rehabilitation
2
Description
Control group: This group receives usual cardiac rehabilitation programs at the hospital.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital, Isfahan
Full name of responsible person
Masoumeh Sadeghi
Street address
3nd Moshtagh St
City
Isfahan
Province
Isfehan
Postal code
81661 73414
Phone
+98 31 3260 0961
Email
fallah@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Building No. 4, Vice Chancellor for Research and Technology
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Fallah
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shahid Ardestani St., Shahid Babaei Air Base
City
Isfahan
Province
Isfehan
Postal code
8164173375
Phone
+98 31 3577 3002
Email
fallah@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Fallah
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shaheed ardestani Blvd, Shahid Babaei Air Base
City
Isfahan
Province
Isfehan
Postal code
8164173375
Phone
+98 31 3577 3002
Fax
Email
zfallah88@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Fallah
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shaheed ardestani Blvd, Shahid Babaei Air Base
City
Isfahan
Province
Isfehan
Postal code
8164173375
Phone
+98 31 3577 3002
Fax
Email
fallah@mui.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
Undecided - It is not yet known if there will be 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