NCT06707116

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 24, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

Health LiteracyGender Differences

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 month

Secondary Outcomes (1)

  • Cardiac Self-Efficacy Scale

    1 month

Study Arms (1)

Study group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Mohammed ElSayed Zaky Principle Investigator, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2024

First Posted

November 27, 2024

Study Start

January 1, 2025

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share