The Effect of Cardiac Educational Program on Level of Knowledge and Satisfaction Among Coronary Artery Disease Patients in North of Jordan

March 21, 2020 updated by: Jordan University of Science and Technology

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 00962
        • Recruiting
        • Faculty of Nursing / Department of Adult Health Care
        • Contact:
        • Contact:
          • Wejdan Khater
        • Principal Investigator:
          • Raghad Tawalbeh, Bch
        • Sub-Investigator:
          • Eejdan Khater, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. mentally competent since cognitive impairment negatively affects the comprehension of the cardiac educational program content
  2. able to communicate verbally
  3. able to read and write Arabic language
  4. more than 18 years
  5. stable and the previous attack not less than 24 hours

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
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.
Other: 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.
No Intervention: control group
Control group who received the usual care and measure the level of knowledge and satisfaction in pre and post test.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: up to one month
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).
up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB in KAUH#

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not planned yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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