NCT00639470

Brief Summary

The objective of this study is to test legal guardians reading comprehension of their child's post-operative medication administration using three different versions of written medication information (standard fact sheets, easy-to-read fact sheets, and easy-to-read fact sheets accompanied by illustrations).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 13, 2008

Status Verified

August 1, 2008

Enrollment Period

1.6 years

First QC Date

March 12, 2008

Last Update Submit

August 12, 2008

Conditions

Parents

Keywords

Patient Education HandoutParentsPatient Education

Outcome Measures

Primary Outcomes (1)

  • Comprehension of the fact sheets as measured by the Cloze Readability Procedure.

    On the day of discharge

Interventions

easy to read fact sheetsOTHER

easy to read fact sheets with illustrations and without illustrations

Also known as: patient education handouts

Eligibility Criteria

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

You may qualify if:

  • be 18 years of age or older or an emancipated minor
  • ability to see, speak, and hear English
  • have a child who will be undergoing surgery
  • signed surgical consent form
  • have a child staying on hospital pediatric surgical unit after surgery until discharge
  • have a child admitted for at least one day but not more than 7 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13069, United States

Location

Study Officials

  • Sharon Kitchie, PhD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 20, 2008

Study Start

August 1, 2005

Primary Completion

March 1, 2007

Study Completion

August 1, 2008

Last Updated

August 13, 2008

Record last verified: 2008-08

Locations

US(1)