Developing a Family-centered Health Program and Comparing its Effectiveness with Cardiac Rehabilitation Program on Biological and Psychological Components in Individuals with Coronary Heart Disease
Developing a Family-centered Health Program and Comparing its Effectiveness with Cardiac Rehabilitation Program on Biological and Psychological Components in Individuals with Coronary Heart Disease
Design
Clinical trial with one control and two intervention groups, with parallel groups, designed for 120 patients, without blindness, randomized.
Settings and conduct
This study is performed at ward 7, CCU (K), CCU (G) and the Rehabilitation center at Rajaie Cardiovascular, Medical and Research Center Hospital on patients with coronary heart disease.Blindness will not do in this study.
Participants/Inclusion and exclusion criteria
The criteria for admitting the subjects in this study include:
- Diagnosis of coronary heart disease
- Education level of junior high school or above
- 40 to 65 years of age
- No history of hospitalization in psychiatric hospitals
- Being married
- Willingness to participate in the study
The exclusion criteria for the experimental group include:
- Reluctance to continue attending the intervention sessions
- Patients with acute myocardial infarction or acute coronary syndrome
- History of Coronary Artery Bypass Grafting
- History of inflammatory diseases such as collagen vascular disease, vascular necrosis, and chronic infectious diseases
Intervention groups
First in the intervention group 1: drug treatments and family-centered health program and in intervention group 2: drug treatments and cardiac rehabilitation program.
Main outcome variables
Biological components (blood pressure and body mass index) and psychological (quality of life related to health, attitude and adherence to self-care behavior)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210307050608N1
Registration date:2022-03-14, 1400/12/23
Registration timing:registered_while_recruiting
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Negin Dorri
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 0944
Email address
negin.dorri@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-05-21, 1401/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing a Family-centered Health Program and Comparing its Effectiveness with Cardiac Rehabilitation Program on Biological and Psychological Components in Individuals with Coronary Heart Disease
Public title
Developing a Family-centered Health Program and Comparing its Effectiveness with Cardiac Rehabilitation Program on Biological and Psychological Components in Individuals with Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for admitting the subjects in this study include:- Diagnosis of coronary heart disease patients.
- Education level of junior high school or above
- 40 to 65 years of age
- No history of hospitalization in psychiatric hospitals
- History of Percutaneous Coronary Intervention
- Being married
- Willingness to participate in the study
Exclusion criteria:
The exclusion criteria for the experimental group include Reluctance to continue attending the intervention sessions
- Patients with acute myocardial infarction or acute coronary syndrome
- History of Coronary Artery Bypass Grafting (CABG)
- History of inflammatory diseases such as collagen vascular disease, avascular necrosis, and chronic infectious diseases
- Primary Percutaneous Coronary Intervention
Age
From 40 years old to 65 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individuals are randomly divided into two groups of intervention and one control group using random number table. In this method, the first selected number (randomly) set in the first intervention group and the next numbers assign to the second intervention and control groups respectively. Intervention group 1 receive drug treatments 8 sessions of Family-centered Health Program, intervention group 2 receive drug treatments and 8 sessions of Cardiac Rehabilitation Program and the third group as the control, only receive drug treatments.
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
Faculty of Psychology and Educational Sciences
Street address
No. 3. Doulatshahi Ave., Rastvan Ave., Darrus., Pasdaran Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1944965711
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.UT.PSYEDU.REC.1400.050
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.11
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with angina pectoris
Primary outcomes
1
Description
The effectiveness of Family-centered health program Blood Pressure
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
In this study, patients with coronary heart disease (CHD) will be identified by cardiologists.
2
Description
The effectiveness of Family-centered health program in Body Mass Index
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
BMI is weight in kilograms divided by height in meters squared. Weight will be measured using a digital scale with 100 gram accuracy, and height will be measured accurately using a non-stretching tape measure with 0.5 accuracy.
3
Description
The effectiveness of Family-centered health program in Awareness, attitudes, and adherence to self-care behaviors
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
In this study, self-care will be determined based on the subject's score on the Health Behavior Scale (Conn et al., 1991).
4
Description
The effectiveness of Family-centered health program model in Health-related quality of life
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
In this study, health-related quality of life will be determined based on the subject's score in the Health-Related Quality of Life Scale.
5
Description
The effectiveness of Family-centered health program model on depression, Anxiety and Stress
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
In this study, depression, Anxiety and Stress level will be determined based on t The Depression, Anxiety and Stress Scale - 21 Items.
Secondary outcomes
1
Description
Heart Rate
Timepoint
Before an intervention, immediately after the intervention, 3 months after the end of intervention
Method of measurement
In this study, heart rate will be determined by heart rate monitor device.
Intervention groups
1
Description
Intervention group: Drug treatments and 8 sessions of Family-centered Health Program receive 2 to 2.5 hours and one a week.
Category
Diagnosis
2
Description
Intervention group: Drug treatments and 8 sessions of Cardiac Rehabilitation Program receive 2 to 2.5 hours and one a week.
Category
Diagnosis
3
Description
Control group: They only receive drug treatment.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
Negin Dorri
Street address
Number 3- Doulatshahi Ave- Ehteshamie Street- Darrus- Pasdaran Street Tehran
City
Tehran
Province
Tehran
Postal code
1944965711
Phone
+98 21 2254 0944
Email
negin.dorri@ut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Psychology and Educational Sciences
Full name of responsible person
Shirin Naderi
Street address
No. 3. Doulatshahi Ave., Rastvan Ave., Darrus., Pasdaran Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1944965711
Phone
+98 21 8825 9378
Email
psyedu@ut.ac.ir
Web page address
https://psyedu.ut.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Psychology and Educational 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
University of Tehran Kish International Campus Branch
Full name of responsible person
Negin Dorri
Position
PhD student of Health Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Number 3- Doulatshahi Ave- Ehteshamie Street- Darrus- Pasdaran Street Tehran
City
Tehran
Province
Tehran
Postal code
1944965711
Phone
+98 21 2254 0944
Email
negin.dorri@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran Kish International Campus Branch
Full name of responsible person
Negin Dorri
Position
PhD Student of Health Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Number 3- Doulatshahi Ave- Ehteshamie Street- Darrus- Pasdaran Street Tehran
City
Tehran
Province
Tehran
Postal code
1944965711
Phone
+98 21 2254 0944
Email
negin.dorri@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran Kish International Campus Branch
Full name of responsible person
Negin Dorri
Position
PhD Student of Health Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Number 3- Doulatshahi Ave- Ehteshamie Street- Darrus- Pasdaran Street. Tehran
City
Tehran
Province
Tehran
Postal code
1944965711
Phone
+98 21 2254 0944
Email
negin.dorri@ut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All related data to participants are shared after hiding patient's name.
When the data will become available and for how long
The period of access to the present research data will be available 6 months after publication of the research results in the form of research articles.
To whom data/document is available
The present study data will be available only to researchers working in the academic and scientific institutions.
Under which criteria data/document could be used
The output of statistical analysis will be available
From where data/document is obtainable
Applicants can apply for documentation and data via email at negin.dorri@ut.ac.ir
What processes are involved for a request to access data/document
After completion of the research and publication of the extracted articles, it will be available for a maximum 6 months later.