NCT01708395

Brief Summary

The investigators believe that patients with ulcerative colitis are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.

Trial Health

87
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 Oct 2012

Typical duration 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 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

2.4 years

First QC Date

October 15, 2012

Last Update Submit

August 14, 2015

Conditions

Inflammatory Bowel Disease

Keywords

Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

  • Validity of patient self reporting

    The validity of patient self report on details of their ulcerative colitis compared to chart review. Validity is defined as a match between patient self report and medical records.

    12 months

Study Arms (2)

Cohort 1

First 50 patients

Cohort 2

2nd group of 50 patients

Eligibility Criteria

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

Adults over 18 years of age

You may qualify if:

  • MD documented diagnosis of ulcerative colitis
  • current of past prescription for anti-TNF medication
  • at least 18 years of age
  • access to medical records to verify information

You may not qualify if:

  • unwilling or unable to provide informed consent for study participation
  • unable to access or use internet
  • less than 18 years of age
  • diagnosis of crohn's disease or IBD-U
  • illiterate or does not possess minimum level of literacy required to complete questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 17, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

US(1)