Cardiac DiseasesNCT06707116
Health Literacy As a Mediator Between Gender, Illness Identity, and Self-Efficacy
An observational study of Cardiac Diseases, run by Cairo University.
Trial summary
The goal of this observational study is to understand the role of health literacy in shaping the relationship between gender differences, illness identity, and self-efficacy in geriatric patients with cardiac diseases. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Cardiac Diseases
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients aged 30 years and older who have been diagnosed with cardiac diseases, such as coronary artery disease, heart failure, or arrhythmias. These individuals are actively receiving regular medical care for their cardiac conditions and are living in the community or non-acute care settings. The population includes both male and female participants to explore gender differences in illness identity, health literacy, and self-efficacy. Participants are expected to have a baseline level of health literacy sufficient to comprehend and complete the study surveys, as the research focuses on the mediating role of health literacy.
Who may be able to join
- Adults aged 30 years or older.
- Diagnosed with a cardiac disease (e.g., heart failure, coronary artery disease, arrhythmia).
- Able to provide informed consent.
- Sufficient health literacy to complete surveys in the study language.
- Currently under regular medical care for their cardiac condition.
Who cannot join
- Individuals with a cognitive impairment or diagnosis of dementia that could interfere with survey participation.
- Patients with co-morbid terminal illnesses that significantly impact life expectancy (e.g., advanced cancer).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Mediating Role of Health Literacy in the Relationship Between Gender Differences, Illness Identity, and Self-Efficacy Patients with Cardiac Diseases: a Structural Equation Model
The goal of this observational study is to understand the role of health literacy in shaping the relationship between gender differences, illness identity, and self-efficacy in geriatric patients with cardiac diseases. The main question it aims to answer is:
Does health literacy mediate the relationship between gender, illness identity, and self-efficacy in elderly cardiac patients?
Participants with diagnosed cardiac conditions, will complete online surveys assessing their health literacy, illness identity, and self-efficacy over a one-year period. Structural Equation Modeling (SEM) will be used to analyze the relationships among these variables.
- Conditions
- Cardiac Diseases
- Keywords
- Health Literacy, Gender Differences
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness Identity Questionnaire (IIQ)
Description: The Illness Identity Questionnaire (IIQ) is a 25-item, self-report, paper-and-pencil questionnaire that was initially used and validated in adolescents and young adults with type 1 diabetes mellitus. Patients are asked to indicate how much they agree with 25 statements, using a 5-point Likert scale ranging from 1-5 (strongly disagree to strongly agree). The IIQ consists of a 5-item rejection scale (items 1-5); 5-item acceptance scale (items 6-10); an 8-item engulfment scale (items 11-18); and 7-item enrichment scale (items 19-25).
Measured: 1 month
Secondary outcomes (1)
Cardiac Self-Efficacy Scale
The Cardiac Self-Efficacy Scale (CSES) is a valuable tool used to assess how confident individuals with heart conditions feel about managing their illness and maintaining daily activities. This scale provides insight into two main areas of self-efficacy: the ability to control symptoms, such as chest pain or fatigue, and the capacity to maintain physical and emotional well-being despite the challenges posed by their condition.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elsayed Zaky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707116
- Sponsor's protocol ID
- Health Literacy
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Role of Health Literacy in the Relationship Between Gender Differences, Illness Identity, and Self-Efficacy Patients with Cardiac Diseases: a Structural Equation Model
- ClinicalTrials.gov ID
- NCT06707116
- Acronym / sponsor ID
- Health Literacy
- Conditions
- Cardiac Diseases
- Keywords
- Health Literacy, Gender Differences
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
The goal of this observational study is to understand the role of health literacy in shaping the relationship between gender differences, illness identity, and self-efficacy in geriatric patients with cardiac diseases. The main question it aims to answer is:
Does health literacy mediate the relationship between gender, illness identity, and self-efficacy in elderly cardiac patients?
Participants with diagnosed cardiac conditions, will complete online surveys assessing their health literacy, illness identity, and self-efficacy over a one-year period. Structural Equation Modeling (SEM) will be used to analyze the relationships among these variables.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients aged 30 years and older who have been diagnosed with cardiac diseases, such as coronary artery disease, heart failure, or arrhythmias. These individuals are actively receiving regular medical care for their cardiac conditions and are living in the community or non-acute care settings. The population includes both male and female participants to explore gender differences in illness identity, health literacy, and self-efficacy. Participants are expected to have a baseline level of health literacy sufficient to comprehend and complete the study surveys, as the research focuses on the mediating role of health literacy.
Key inclusion criteria (5 listed)
- Adults aged 30 years or older.
- Diagnosed with a cardiac disease (e.g., heart failure, coronary artery disease, arrhythmia).
- Able to provide informed consent.
- Sufficient health literacy to complete surveys in the study language.
- Currently under regular medical care for their cardiac condition.
Key exclusion criteria (2 listed)
- Individuals with a cognitive impairment or diagnosis of dementia that could interfere with survey participation.
- Patients with co-morbid terminal illnesses that significantly impact life expectancy (e.g., advanced cancer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Illness Identity Questionnaire (IIQ)
Time frame: 1 month
Description: The Illness Identity Questionnaire (IIQ) is a 25-item, self-report, paper-and-pencil questionnaire that was initially used and validated in adolescents and young adults with type 1 diabetes mellitus. Patients are asked to indicate how much they agree with 25 statements, using a 5-point Likert scale ranging from 1-5 (strongly disagree to strongly agree). The IIQ consists of a 5-item rejection scale (items 1-5); 5-item acceptance scale (items 6-10); an 8-item engulfment scale (items 11-18); and 7-item enrichment scale (items 19-25).
1 secondary outcome
Cardiac Self-Efficacy Scale
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cardiac Diseases
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Diseases, run by Cairo University.
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 2 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: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed ElSayed Zaky Principle Investigator, Ph.D (01000553254, Mohammed.Zaky@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness Identity Questionnaire (IIQ) (time frame: 1 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 29 Nov 2024.