NCT03170024

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

5.5 years

First QC Date

April 26, 2017

Last Update Submit

May 10, 2021

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Males or females 18 years of age and older with congenital heart disease.

You may not qualify if:

  • Developmentally delayed subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital Adult Congenital Heart Clinic

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Susan Fernandes, LP.D.P.A.C

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Pediatrics - Cardiology Clinical Professor, Medicine - Cardiovascular Medicine

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 30, 2017

Study Start

October 31, 2015

Primary Completion

May 7, 2021

Study Completion

May 7, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)