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Computer-Assisted Cancer Risk Behavior Counseling

This study has been terminated.
(Administratively terminated.)
Sponsor:
Collaborator:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00242645
First received: October 19, 2005
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus
Hypertension
Behavioral: Health Information
Behavioral: Preventive Services
Behavioral: Computer tailored information
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Computer-Assisted Cancer Risk Behavior Counseling

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 200
Study Start Date: June 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Patients are randomized into one of three groups. Before a single visit with diabetes care provider, the patient is called to answer interview questions about their health, diabetic care and behavior habits. After a patient visits with their doctor, they are called again to answer question about the visit they just had. If a patient is place into group A or B, based on their answers to the questions they are mailed a printed report before their doctor visit. The report will indicate how things are going the patient's diabetic care and recommended questions to ask his/her health care provided about diabetes. Group A feedback report will emphasize the risks from diabetes and the feedback reports for Group B will emphasize things to do to protect oneself from problems from having diabetes. Participants randomized to Group C will only receive printed reports after a doctors visit. No extra visit will be scheduled with the participants doctor, no travel is required, no blood tests are required and ther doctor will not be involved in the study unless the study participant chooses to discuss it with his/her doctor.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242645

Sponsors and Collaborators
Thomas Jefferson University
Investigators
Study Chair: Christopher N Sciamanna, MD Thomas Jefferson Unversity
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00242645     History of Changes
Other Study ID Numbers: 04F.244, K07-CA91976-0
Study First Received: October 19, 2005
Last Updated: August 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Doctor-Patient relation
Physician-Patient relation
Diabetes
Office visits
Comparative Study
Health behavior
Randomized controlled trials
Health Promotion
Health Education
Computer-tailor information

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014