Effect of a Care Plan Based on the Pender Health Promotion Model on Adherence to the Treatment Regimen in Patients with Coronary Artery Disease
Design
A clinical trial with a control group in which the data will be collected in two stages before and after the intervention for the control and control group simultaneously. 64 samples were randomly assigned into two groups of 32 subjects.
Settings and conduct
This study will be carried out at the Charman Heart Center of Isfahan.
Participants/Inclusion and exclusion criteria
The company participated in a training program on compliance with treatment regimen during the study
Affected by coronary artery disease with confirmation of a doctor's diagnosis
Passed at least 6 months of diagnosis
family's willingness to participate in the program
The company participated in a training program on compliance with treatment regimen during the study
Intervention groups
In the test group, the Pandor Health Promotion-Based Health Care Program is grouped in 4 consecutive sessions each week. The duration of each session is 45 to 60 minutes.
For the control group after the completion of the study, two discussion sessions are held on the importance of the diet, diet and exercise regime, and after the program is implemented, training books will be given about the importance of the treatment regime
Main outcome variables
visits to these hospitals
the cost of treatment
the complications of the disease
General information
Reason for update
Acronym
CAD
IRCT registration information
IRCT registration number:IRCT20180227038886N1
Registration date:2018-08-02, 1397/05/11
Registration timing:registered_while_recruiting
Last update:2018-08-02, 1397/05/11
Update count:0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Forough Faroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3252 5978
Email address
f.faroughi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-08, 1397/02/18
Expected recruitment end date
2018-09-09, 1397/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a care plan based on Pender’s Health Promotion Model on adherence to the treatment regimen in patients with coronary Artery Disease
Public title
Effects of Pender’s Health Promotion Model on adherence to the treatment regimen
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are alert and able to communicate.
Affected by coronary artery disease with confirmation of a doctor's diagnosis
Passed at least 6 months of diagnosis
family's willingness to participate in the program
family's willingness to participate in the program
Exclusion criteria:
The company participated in a training program on compliance with treatment regimen during the study
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by simple and continuous sampling. The samples will be assigned randomly into two groups of test and control according to the conditions of entry into the study. In this way, a card with number one and a card with number two in the envelope are placed in the package and they are asked to select a card. The people who choose the first-card number are in the control group in the group and those who take the number two card. Participants are unaware of being in the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
After determine of samples with inclusion criteria, samples allocated to the experimental and control groups. so, all of the samples enter to the study, but they don't know about the groups of this study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Dormitory of Isfahan University of Medical Sciences. Hazar Jarib Street. Shiraz gate
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-02-09, 1396/11/20
Ethics committee reference number
IR.MUI.REC.1396.3.916
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
IX Diseases of the circulatory system
2
Description of health condition studied
Ischemic myocardium
ICD-10 code
I25.2
ICD-10 code description
IX Diseases of the circulatory system
3
Description of health condition studied
Unstable ungine
ICD-10 code
I20.0
ICD-10 code description
IX Diseases of the circulatory system
Primary outcomes
1
Description
Percentage of people who have treatment adherence
Timepoint
Before the intervention begins. One month after the intervention and three months after the intervention
Method of measurement
Treatment Regimen Adherence Questionnaire
2
Description
Percentage of people who have drug adherence
Timepoint
Before the intervention and one month and three months after the end of the intervention
Method of measurement
morisky Medication Adherence Questionnaire
3
Description
Percentage of people who have nutrition adherence
Timepoint
Before the intervention begins. One month after the intervention and three months after the intervention
Method of measurement
nutrition Adherence Questionnaire
4
Description
Percentage of people who have exercise adherence
Timepoint
Before the intervention begins. One month after the intervention and three months after the intervention
Method of measurement
exercise Adherence Questionnaire
Secondary outcomes
1
Description
Score Adherence to the treatment regime
Timepoint
Pre-intervention and one month and three months after the end of the intervention
Method of measurement
treatment Adherence Questionnaire
2
Description
Score Adherence to the medication regime
Timepoint
Pre-intervention and one month and three months after the end of the intervention
Method of measurement
medication Adherence Questionnaire
3
Description
Score Adherence to the nutrition regime
Timepoint
Pre-intervention and one month and three months after the end of the intervention
Method of measurement
nutrition Adherence Questionnaire
4
Description
Score Adherence to the Exercise regime
Timepoint
Pre-intervention and one month and three months after the end of the intervention
Method of measurement
Exercise Adherence Questionnaire
Intervention groups
1
Description
''Intervention group:'' In the test group, the Pandor Health Promotion-Based Health Care Program is grouped in 4 consecutive sessions each week. The duration of each session is 45 to 60 minutes. During the sessions, lecture, question and answer, and group discussion are used.
Category
Prevention
2
Description
Control group: In this group, there is no intervention during the study. But at the end of the intervention in the intervention group, the training group will also be given to the group in the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Heart Center
Full name of responsible person
Forough Faroughi
Street address
Chamran Hospital،Salman Farsi Street،Bozorgmehr street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 17 3252 5978
Email
f.faroughi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghjoo javanmard
Street address
Isfahan university of medical Sciences.Hazar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.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
Forough Faroughi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences.Hazarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 17 3252 5978
Email
f.faroughi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
forough faroughi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences. Hazarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 17 3252 5978
Email
f.faroughi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Forough Faroughi
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences. Hazarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 17 3252 5978
Email
f.faroughi@nm.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
It will be discussed in a clinical study and report how the study will be conducted
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers of academic institutions
Under which criteria data/document could be used
If reference is given to the study
From where data/document is obtainable
f.faroughi3504@gmail.com
09117003504
What processes are involved for a request to access data/document
Expression of the request by email and checking access to it and sending it