Find out the effectiveness of the instruction program on patients' knowledge and practices about safe measures post implantable cardioverter defibrillator.
Design
Quantitative study, quasi-experimental design.
Settings and conduct
The research was conducted on patients with implantable cardioverter defibrillator devices who were attending for clinical examination and programming their devices at Baghdad City in Al-Karkh Health Directorate (The Ibn- Al-Bitar Specialized Center for Cardiac Surgery).
Participants/Inclusion and exclusion criteria
The inclusion criteria for the current study included adult patients with ICD who attended the Ibn – Al-Bitar specialized center in Baghdad city, all patients regardless of the number of years of implantation, and willing to participate in all aspects of the study. The exclusion criteria included patients involved with other studies at the same time as the current study, hospitalized patients, and Patients who have Down syndrome
Intervention groups
The pre-test was done for both the study and control groups, the intervention of the instructional program was implemented for the study group, and the post-test was applied after 4 weeks for both groups.
Main outcome variables
1. Assess patients' knowledge about safe measures post implantable cardioverter defibrillator.
2. Assess patients' practices about safe measures post implantable cardioverter defibrillator.
General information
Reason for update
Acronym
ICD Safe Measures Trial
IRCT registration information
IRCT registration number:IRCT20240813062748N1
Registration date:2024-08-17, 1403/05/27
Registration timing:retrospective
Last update:2024-08-17, 1403/05/27
Update count:0
Registration date
2024-08-17, 1403/05/27
Registrant information
Name
Mohammed Kadhum Sadiq
Name of organization / entity
College of Nursing, University of Baghdad
Country
Iraq
Phone
+964 770 258 1696
Email address
mohammed.sadiq2102p@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-29, 1402/08/07
Actual recruitment start date
2023-07-23, 1402/05/01
Actual recruitment end date
2023-10-29, 1402/08/07
Trial completion date
2024-08-01, 1403/05/11
Scientific title
Effectiveness of an Instructional Program on Patients’ Safe Measures Post Implantable Cardioverter Defibrillator
Public title
Daily activities patients post ICD implantation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had an implantable cardioverter defibrillator device before (3) months and above
A patient who has agreed to participate in the study and were able to attend the follow-up regularly
Patients with a traditional implantable cardioverter defibrillator device
Exclusion criteria:
Hospitalized patients
Patients had an amputation
Patients who had mental retardation such as (Down syndrome).
Patients involved with other studies at the same time as the current study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
92
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were unaware of the instructional program's content, ensuring the blind technique, this was significant since patients may indoctrinate themselves in order to raise their knowledge and practice levels, thus influencing the findings of this study, therefore, a single-blind approach was used to avoid possible biases.
Placebo
Not used
Assignment
Crossover
Other design features
quasi-experimental design use (control, manipulation, with simple randomized allocation of patients in groups)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of College of Nursing/ University of Baghdad
Street address
Bab al-Mua'adham Bridge Ave,. al-Mua'adhamTown
City
Baghdad
Postal code
10061
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
5
2
Ethics committee
Name of ethics committee
Ethics committee of Ibn Al-Bitar Cardiac Center
Street address
Iraq museum Ave., Al-Salihiya Town
City
Baghdad
Postal code
10003
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
1489
Health conditions studied
1
Description of health condition studied
Many patients who receive Implantable Cardioverter Defibrillators (ICDs) lack adequate knowledge and understanding of the necessary safety measures post-implantation. Research indicates that patients often feel that the information provided during their care is insufficient and not tailored to their specific needs. To address this gap
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the primary outcome of the study is to evaluate the effectiveness of the instructional program on patients' safety measures regarding the knowledge and practice post-ICD, and optimistic to improve the level of an awareness post the intervention for the study group.
Timepoint
pre-test was done for both study and control group and intervention of instructional program implemented for study group and post-test apply after 4 weeks for both groups.
Method of measurement
The primary outcome variable was measured using self-report data collection, which was then applied to the statistical analysis of the data.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients (study group) received the pre-test and intervention of instructional program regarding the safe measures and post-test apply after 4 weeks for group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The Ibn- Al-Bitar Specialized Center for Cardiac Surgery
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Baghdad\ College of Nursing
Proportion provided by this source
50
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
College of Nursing \ University of Baghdad
Full name of responsible person
Mohammed Kadhum Sadiq
Position
Ph.D. Sc. Student
Latest degree
Master
Other areas of specialty/work
Specialize academic Nurse / cardiac devises
Street address
No.58., Schools Street Ave., Third Street., Hurriya Town
City
Baghdad
Province
Al- Kadhimiya
Postal code
10001
Phone
+964 770 258 1696
Email
mohammed.sadiq2102p@conursing.uobaghdad.edu.iq
Web page address
https://orcid.org/0009-0009-8907-8667
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing \ University of Baghdad
Full name of responsible person
Wafaa Abed Ali Hattab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Bab Al muaadham Bridge Ave., Bab Al muaadham Town
City
Baghdad
Province
Bab Al muaadham
Postal code
10061
Phone
+964 770 785 8731
Email
Waffa.a@conursing.uobaghdad.edu.iq
Web page address
https://orcid.org/0000-0002-2297-6050
Person responsible for updating data
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Mohammed Kadhum Sadiq
Position
Ph.D. Sc. Student, Adult Nursing
Latest degree
Master
Other areas of specialty/work
Specialize academic Nurse/ cardiac devices
Street address
No. 58, Schools Street, Third Ave., HuriyaTown
City
Baghdad
Province
Kadhimiya
Postal code
10001
Phone
+964 770 258 1696
Fax
Email
mohammed.sadiq2102p@conursing.uobaghdad.edu.iq
Web page address
https://orcid.org/0009-0009-8907-8667
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
Non-probability (purposive sample) has been chosen to gather reliable and precise data, two groups of pre-posttest methods involved (60) patients who had an implantable cardioverter defibrillator device and were attending the Ibn-Al-Bitar Specialized Center for Cardiac Surgery for clinical examination as well as programming their devices, the patients were selected to participate in the study, they were divided into two groups, a total of 30 patients were assigned to the study group, while an equal number of patients were assigned to the control group, the control group did not participate in the instructional program, every group had the same demographic characteristics
When the data will become available and for how long
The data files will become available on https://orcid.org/0009-0009-8907-8667
Starting 3 months after publication.
To whom data/document is available
Open access, available for people.
Under which criteria data/document could be used
no criteria, it is open access.
From where data/document is obtainable
Mohammed Kadhum Sadiq,
mohammed.sadiq2102p@conursing.uobaghdad.edu.iq
https://orcid.org/0009-0009-8907-8667
What processes are involved for a request to access data/document
the time needed to follow through these processes, when receiving the request the researcher answering directly