Health Literacy in Adults With Congenital Heart Disease | NCT03170024

Studies
Health Literacy in Adults With Congenital Heart Disease

NCT03170024

Sponsor

Stanford University

Status

Completed

Last Update Posted

May 12, 2021Actual

Enrollment

187Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2015Actual

Primary Completion Date

May 7, 2021Actual

Completion Date

May 7, 2021Actual

First Submitted Date

Apr 26, 2017

First Submission Date that Met QC Criteria

May 25, 2017

First Posted Date

May 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2021

Last Update Posted Date

May 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Susan Fernandes, Clinical Professor, Pediatrics - Cardiology Clinical Professor, Medicine - Cardiovascular Medicine, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess Literacy	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Fernandes, LP.D.P.A.C	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Hospital Adult Congenital Heart Clinic		Palo Alto	California	94304	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided