Coronary Artery DiseaseNCT04102787
The Effect of Cardiac Educational Program on Level of Knowledge and Satisfaction Among Coronary Artery Disease Patients in North of Jordan
A study testing cardiac educational program in people with Coronary Artery Disease, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Background: Although patients' education programs improve health-related knowledge that promote individual capacity to understand basic health information, there is a scarcity in the studies that address cardiac educational programs for patients with coronary artery diseases in Jordan and their impact on patients'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- cardiac educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteJordan
- Study dates
- 28 Oct 2018to 11 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mentally competent since cognitive impairment negatively affects the comprehension of the cardiac educational program content
- able to communicate verbally
- able to read and write Arabic language
- more than 18 years
- stable and the previous attack not less than 24 hours
Who cannot join
- Exclusion criterion included patients with life- threatening comorbidities like (heart failure (HF), Valve Diseases, Chronic Obstructive Pulmonary Disease (COPD), patients with Pacemaker or Implanted Cardioverter Defibrillator (ICD), and any type of chronic cardiac arrythmias.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Faculty of Nursing / Department of Adult Health Care
Irbid, 00962
Wejdan Khater, PHD, +962-2-7201000 ext. 23715, wkhater@just.edu.jo
Wejdan Khater
About this study
Background: Although patients' education programs improve health-related knowledge that promote individual capacity to understand basic health information, there is a scarcity in the studies that address cardiac educational programs for patients with coronary artery diseases in Jordan and their impact on patients' health outcomes.
Aim: the aims of this study are to assess the level of knowledge and satisfaction of patients with coronary artery disease and to evaluate the effect of implementing a cardiac educational program on patient's level of knowledge and satisfaction.
Read more
Methods: This study will be carried out using a true experimental two groups pre and post- test. The necessary information will be collected from 138 patients with CAD in the north of Jordan using the Coronary Artery Disease Education Questionnaire (CADE-Q) and the Patient Satisfaction Scale (PSS).
The expected outcomes include establishing foundational knowledge about the effectiveness of cardiac educational program on patient health related out comes. Evidence on the effect of cardiac educational program will help patients to recover from a heart attacks, prevent future heart problems, hospital stays and death related to heart problems as well as making a necessary life style changes.
Keywords: coronary artery disease, educational program, patient satisfaction, patient knowledge.
- Conditions
- Coronary Artery Disease
- Being tested
- cardiac educational program
- Keywords
- coronary artery disease, educational program, patient satisfaction, patient knowledge.
- Medical subject headings
- Coronary Artery Disease, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac educational programOther
"Love your Heart" is a Heart Foundation program (2016), the Arabic version will be used as the educational program in this study. The programme has been adopted from relevant articles in the evidence- based literature. The program is a guide to support recovery and good heart health. It includes the following: anatomy and physiology of the heart, causes, symptoms and risk factors of CAD, healthy diet, physical activity, weight management, and risk factors management.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Experimental group who received the Cardiac educational program and will be applied for Coronary Artery Disease patients, and measure the level of knowledge and satisfaction in pre and post test. Receives: Other: cardiac educational program |
| control group | No intervention | Control group who received the usual care and measure the level of knowledge and satisfaction in pre and post test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of knowledge
level of knowledge using The Coronary Artery Disease Education Questionnaire Short Version (CADE- Q SV) . The CADEQ-SV was designed to be a true/false/I do not know questionnaire, with 20 items (4 in each domain). The CADE- Q SV was divided into four subscales. These include the following: firstly, items number 1, 3, 6,11 and 15 are related to the first part which covers the medical condition. Secondly, items number 2, 12, 16, and 18 are related to the second part which covers the risk factors. Thirdly, items number 5,9,14, and 20 deal with the third part which covers the nutrition. Fourthly, items number 4, 18, 13, and 17 deal with the fourth part which covers the physical exercise. Finally, items number 7, 10, and 19 are concerned with the fourth part which covers the psychological factors. Each correct answer equals
1 point; therefore, the maximum score possible is 20 overall
Measured: up to one month
Secondary outcomes (1)
Patient satisfaction
Patient Satisfaction Scale (PSS) to measure the satisfaction level in likert scale (strongly disagree, disagree, not sure agree, and strongly agree).The PSS was designed to evaluate patients' attitudes towards nurses and nursing. It is a 25 items Likert- type summated rating scale with three dimensions of patient satisfaction: technical- professional care, educational relationship, and trusting relationship. Both positive and negative items were included in each subscale. Each question was assessed on a five-point Likert measurement scale ranging from "Strongly agree" (=5) to "Strongly disagree" (=1). The higher the PSS score is, the higher is the patient satisfaction with the nursing care provided (Hinshaw and Atwood 1982).
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start28 Oct 2018
- Primary completion28 Oct 2018
- Study completion11 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pre and post true experimental with two groups control and experimental
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102787
- Sponsor's protocol ID
- IRB in KAUH#
- Status last verified
- Mar 2020
- First submitted
- 12 May 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not planned yet
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardiac Educational Program on Level of Knowledge and Satisfaction Among Coronary Artery Disease Patients in North of Jordan
- ClinicalTrials.gov ID
- NCT04102787
- Acronym / sponsor ID
- IRB in KAUH#
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, educational program, patient satisfaction, patient knowledge.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 28 Oct 2018 (actual)
- Primary completion
- 28 Oct 2018 (actual)
- Study completion
- 11 Dec 2020 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Although patients' education programs improve health-related knowledge that promote individual capacity to understand basic health information, there is a scarcity in the studies that address cardiac educational programs for patients with coronary artery diseases in Jordan and their impact on patients' health outcomes.
Aim: the aims of this study are to assess the level of knowledge and satisfaction of patients with coronary artery disease and to evaluate the effect of implementing a cardiac educational program on patient's level of knowledge and satisfaction.
Methods: This study will be carried out using a true experimental two groups pre and post- test. The necessary information will be collected from 138 patients with CAD in the north of Jordan using the Coronary Artery Disease Education Questionnaire (CADE-Q) and the Patient Satisfaction Scale (PSS).
The expected outcomes include establishing foundational knowledge about the effectiveness of cardiac educational program on patient health related out comes. Evidence on the effect of cardiac educational program will help patients to recover from a heart attacks, prevent future heart problems, hospital stays and death related to heart problems as well as making a necessary life style changes.
Keywords: coronary artery disease, educational program, patient satisfaction, patient knowledge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre and post true experimental with two groups control and experimental
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: cardiac educational programExperimental group who received the Cardiac educational program and will be applied for Coronary Artery Disease patients, and measure the level of knowledge and satisfaction in pre and post test. |
| control group | No intervention | –Control group who received the usual care and measure the level of knowledge and satisfaction in pre and post test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- mentally competent since cognitive impairment negatively affects the comprehension of the cardiac educational program content
- able to communicate verbally
- able to read and write Arabic language
- more than 18 years
- stable and the previous attack not less than 24 hours
Key exclusion criteria (1 listed)
- Exclusion criterion included patients with life- threatening comorbidities like (heart failure (HF), Valve Diseases, Chronic Obstructive Pulmonary Disease (COPD), patients with Pacemaker or Implanted Cardioverter Defibrillator (ICD), and any type of chronic cardiac arrythmias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac educational program"Love your Heart" is a Heart Foundation program (2016), the Arabic version will be used as the educational program in this study. The programme has been adopted from relevant articles in the evidence- based literature. The program is a guide to support recovery and good heart health. It includes the following: anatomy and physiology of the heart, causes, symptoms and risk factors of CAD, healthy diet, physical activity, weight management, and risk factors management. | Other | experimental group |
Primary outcome
level of knowledge
Time frame: up to one month
level of knowledge using The Coronary Artery Disease Education Questionnaire Short Version (CADE- Q SV) . The CADEQ-SV was designed to be a true/false/I do not know questionnaire, with 20 items (4 in each domain). The CADE- Q SV was divided into four subscales. These include the following: firstly, items number 1, 3, 6,11 and 15 are related to the first part which covers the medical condition. Secondly, items number 2, 12, 16, and 18 are related to the second part which covers the risk factors. Thirdly, items number 5,9,14, and 20 deal with the third part which covers the nutrition. Fourthly, items number 4, 18, 13, and 17 deal with the fourth part which covers the physical exercise. Finally, items number 7, 10, and 19 are concerned with the fourth part which covers the psychological factors. Each correct answer equals 1 point; therefore, the maximum score possible is 20 overall
1 secondary outcome
Patient satisfaction
Time frame: up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No. not planned yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Nursing / Department of Adult Health Care
Irbid, Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac educational program in people with Coronary Artery Disease, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of knowledge (time frame: up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.