Determining the effect of implementing family-centered empowerment program on the recovery process and treatment compliance of patients after coronary angioplasty.
Design
The clinical trial with control group, with parallel groups, without blinding.
The samples will be allocated in two intervention and control groups by random block allocation method with 4 blocks of equal size and a combination of letters A for the intervention group and B for the control group.
The sample size will be 84 people based on the estimate of the statistical consultant and taking into account the possibility of dropping out.
Settings and conduct
Location: Selected hospitals of Tehran University of Medical Sciences
During 8 sessions, there will be 5 training sessions and 3 follow-up sessions and 1 session every week. Group meetings will be held in groups of 4 to 7 people for 20-30 minutes.
Completing the questionnaires again immediately after the intervention and also 4 weeks after the completion of the interventions
Providing training booklets to both groups.
Participants/Inclusion and exclusion criteria
The study inclusion criteria include:
Adults from18 to 60 years old
Diagnosis of coronary artery disease by a specialist doctor
Presence of patients on the waiting list for coronary angioplasty
The cooperation of one family member with the patient
Having minimum reading and writing literacy for the patient and active family member
Non-entry criteria:
The existence of diagnosed psychological problems
Participate in similar empowerment program
Intervention groups
In this 8-week study, the control group will receive the usual care, while the intervention group will also receive the comprehensive heart empowerment program in addition to the usual care. booklet will be available to the control group in order to comply with ethical considerations.
Main outcome variables
Adherence to Treatment
Recovery process
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220929056055N1
Registration date:2023-04-24, 1402/02/04
Registration timing:registered_while_recruiting
Last update:2023-04-24, 1402/02/04
Update count:1
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
fatemeh ardestani mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4446 3174
Email address
fatemeh.ardestani78@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-06-12, 1402/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of comprehensive family-centered empowerment program on Adherence to Treatment and recovery process in patients after coronary angioplasty
Public title
The effect of comprehensive family-centered empowerment program on Adherence to Treatment and recovery process in patients after coronary angioplasty
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adults from 18 to 60 years old
Diagnosis of coronary artery disease by a specialist doctor
Presence of patients on the waiting list for coronary angioplasty
The cooperation of one family member with the patient
Having minimum reading and writing literacy for the patient and active family member
Exclusion criteria:
Psychological problems has been diagnosed
Failure to participate in a similar empowerment program
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected through continuous sampling and will be divided into two intervention and control groups. The sample members will be allocated in two intervention and control groups by random block allocation method with 4 blocks of equal size and a combination of letters A for the intervention group and B for the control group. Then, the cards containing the blocks are placed inside the standard envelope, and based on the eligible inpatient samples, an envelope will be selected by the researcher by random sampling method, and finally, the method of random allocation of research samples will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Nursing and Midwifery and Rehabilitation Faculty of Tehran U
Street address
Unit 1, No. 28, Asgari Alley, 16 Meters First North, Baath Blvd., Central Janat Abad
City
Tehran
Province
Tehran
Postal code
1474854411
Approval date
2022-09-28, 1401/07/06
Ethics committee reference number
IR.TUMS.FNM.REC.1401.076
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I70-I79
ICD-10 code description
کد ذیل مربوط به بیماری های شریانی است.
Primary outcomes
1
Description
The rate of patient recovery with the recovery process questionnaire
Timepoint
After the intervention and 4 weeks after the end of the intervention
Method of measurement
Questionnaire of recovery process
Secondary outcomes
1
Description
The degree of compliance with the treatment plan in the questionnaire of adherence to treatment regimen
Timepoint
Before and after the intervention and 4 weeks after the end of the intervention
Method of measurement
Questionnaire of adherence to treatment regimen
Intervention groups
1
Description
Intervention group: 8 family-centered intervention sessions will be conducted in the form of 5 group training sessions and 3 follow-up sessions and 1 session every week. Group meetings will be held in groups of 4 to 7 people for 20-30 minutes. During these sessions, he will provide training on the nature of the disease, factors affecting the aggravation or improvement of symptoms, methods of preventing heart diseases by modifying lifestyle, physical activity, proper nutrition, stress control methods, follow-up of drug therapy and adherence to the treatment plan. became. Then, the researcher will encourage the members of the intervention group to have a group discussion and exchange their experiences related to the disease and the complications they experienced and lifestyle. Also, the training booklet will be given to the sample members to read it and ask the researcher any questions that come to their mind. The family members attend the meetings and in these meetings under the supervision of the researcher, they will discuss their problems and how to solve them, which will finally end in adopting a solution and try to strengthen the patients' ability in this field. In the step of educational participation, the family members are asked to transfer the learned information to the patient in the presence of the researcher along with the educational card. The last meeting will be held with the presence of an active member of the family to review the received training and fix the problems and summarize the meetings and evaluate the model. Evaluation is done in two ways: Formative and Summative evaluation. Formative evaluation will be in the form of questions and answers during each session will be from the topics of the previous sessions, and the Summative evaluation will be for the completion of the questionnaires immediately after the intervention and the re-completion of the questionnaires will be done 4 weeks after the completion of the interventions. In order to comply with ethical considerations, the training booklet was also provided to the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Shahrzad Ghiyasvandian
Street address
keshavarz blvd, Dr. gharib st, Imam Khomeini hospital Complex
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
2
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Shahrzad Ghiyasvandian
Street address
Jalal-e-Al-e-Ahmad Hwy, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 1444
Email
Shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr akbar Fotouhi
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8899 2970
Email
vcr@sina.tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Ardestani Mohammadi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 28, Unit 1, Asgari Alley, 16 meters first North, Baath Blvd., Central Janat Abad
City
Tehran
Province
Tehran
Postal code
1474854411
Phone
+98 21 4446 3174
Email
fatemeh.ardestani78@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tawheed Square, Nusrat East St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4517
Email
shghiyas@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Ardestani Mohammadi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 28, Unit 1, Asgari Alley, 16 meters first North, Baath Blvd., Central Janat Abad
City
Tehran
Province
Tehran
Postal code
1474854411
Phone
+98 21 4446 3174
Email
fatemeh.ardestani78@yahoo.com
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