NCT00242645

Brief Summary

To test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_1 diabetes

Status
terminated

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

June 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 25, 2010

Status Verified

August 1, 2010

Enrollment Period

3 years

First QC Date

October 19, 2005

Last Update Submit

August 24, 2010

Conditions

DiabetesDiabetes MellitusHypertension

Keywords

Doctor-Patient relationPhysician-Patient relationDiabetesOffice visitsComparative StudyHealth behaviorRandomized controlled trialsHealth PromotionHealth EducationComputer-tailor information

Outcome Measures

Primary Outcomes (1)

  • To test the effect of receiving computer tailored information about diabetes care before doctor visits and the differential effect of varying types of information

Secondary Outcomes (1)

  • Patient exit interviews after doctor visits about what happened during the visits, such as what was discussed, what tests and consults were ordered and what medications were added or changed.

Interventions

Health InformationBEHAVIORAL
Preventive ServicesBEHAVIORAL
Computer tailored informationBEHAVIORAL

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older;
  • Has type 2 (adult-onset) diabetes;
  • Developed diabetes after the age of 21;
  • Has a scheduled doctor visit about diabetes in the next few months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusHypertensionHealth BehaviorHealth Education

Interventions

Preventive Health Services

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Christopher N Sciamanna, MD

    Thomas Jefferson Unversity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 20, 2005

Study Start

June 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 25, 2010

Record last verified: 2010-08