NCT01060995

Brief Summary

SUMMARY: The purpose of this study is to learn how to better educate patients about oral health procedures and treatments through an improved informed consent process. We will gather information from patients and health care providers, and design and test a computerized consent system called SmartConsent. HYPOTHESIS:

  1. 1.Subjects who use SmartConsent will have increased knowledge (cognitive achievement) about oral health disease and treatment than patients who view the standard consent
  2. 2.Subjects who use SmartConsent will have less decisional conflict in their decision regarding an oral health procedure than those who view the standard consent form
  3. 3.Subjects who use SmartConsent will have greater visit satisfactions scores than those who view the standard consent form

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

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

January 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2013

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

January 29, 2010

Last Update Submit

May 1, 2018

Conditions

Healthy

Keywords

Informed ConsentOral HealthPatient Decision-making

Study Arms (2)

SmartConsent

Subjects receiving SmartConsent informed consent

Standard consent

Subjects receiving standard consent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Urgent Care Clinic at UT Dental Branch at Houston

You may qualify if:

  • Adult
  • English-speaking
  • Diagnosis of pulpal disease

You may not qualify if:

  • Treatment required referral outside of clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • John Valenza, DDS

    UTHSC-Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean and Professor

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

March 26, 2013

Last Updated

May 4, 2018

Record last verified: 2018-05