- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03170024
Health Literacy in Adults With Congenital Heart Disease
May 10, 2021 updated by: Susan Fernandes, Stanford University
Assessment of Health Literacy in Adults With Congenital Heart Disease
Currently, both oral and written health education make certain assumptions about the health literacy of patients and their parents.
The prevalence of health literacy issues is unknown in the adult congenital heart disease (CHD) population.
Having a better understanding of a patient's and/or their parents' health literacy will help us develop appropriate education and teaching tools to meet the patient's and their parents' needs.
Study Overview
Status
Completed
Conditions
Detailed Description
When providers speak with patients regarding their congenital heart disease, they currently have no assessment of the patient's basic health literacy.
If providers are aware of the level of their patients' health literacy, they will be better equipped to provide care on the level the patient best understands.
Study Type
Observational
Enrollment (Actual)
187
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
-
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California
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Palo Alto, California, United States, 94304
- Stanford Hospital Adult Congenital Heart Clinic
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study will be conducted solely in the the Adult Congenital Heart Clinic at Stanford, and patients with congenital heart disease (CHD) will be recruited for the study.
Description
Inclusion Criteria:
- Males or females 18 years of age and older with congenital heart disease.
Exclusion Criteria:
- Developmentally delayed subjects.
- Any subject not meeting inclusion criteria.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess Literacy
Time Frame: The final 3 months will be used for data analysis and the presentation/manuscript preparation.
|
Assess health literacy in human patients ages 18 to 65 with congenital heart disease through data collected from health literacy questionnaire.
|
The final 3 months will be used for data analysis and the presentation/manuscript preparation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan Fernandes, LP.D.P.A.C, Stanford University
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)
October 31, 2015
Primary Completion (Actual)
May 7, 2021
Study Completion (Actual)
May 7, 2021
Study Registration Dates
First Submitted
April 26, 2017
First Submitted That Met QC Criteria
May 25, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
May 12, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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