Clinical Trials Logo
  1. Home
  2. Health Status Unknown
  3. NCT00450931
  4. Details
NCT00450931 Clinical Trial

Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information

Health Status Unknown Clinical Trial

Official title:
Helping Patients and Physicians Make Sense of Medical Data

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00450931
Other study ID # CDR0000513888
Secondary ID VAMC-WRJ-15879DM
Status Active, not recruiting
Phase N/A
First received March 20, 2007
Last updated January 3, 2014

Study information
Verified date September 2008
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.

PURPOSE: This randomized trial is studying how well a drug facts page works compared with a standard brief summary in helping patients and doctors understand medical information.

Description:

OBJECTIVES:

Primary

- Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug.

Secondary

- Comprehension of information contained in the drug facts box and rating of the usability of the drug information.

OUTLINE: This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 4 intervention arms.

- Arm I: Participants receive 2 advertisements for a drug to treat heartburn with a drug facts second page.

- Arm II: Participants receive 2 advertisements as in arm I for drugs to treat heatburn with the standard second page (i.e., brief summary).

Participants in both arms complete the self-reported questionnaire mailed with the advertisement intervention.

PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.

Other known NCT identifiers
  • NCT00386932

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 70 Years
Eligibility DISEASE CHARACTERISTICS:

- English-speaking adults

- Must be able to be chosen by Random Digit Dialing

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

Intervention

Other:
• counseling intervention

• educational intervention

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
White River Junction VAMC National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of two drugs for the same indication No
Primary Knowledge of drug efficacy and side effects of each drug Yes
Secondary Comprehension of information contained in the drug facts box and rating of the usability of the drug information No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03234556 - Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA N/A
Active, not recruiting NCT02194387 - Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members N/A
Completed NCT03725449 - Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma N/A
Terminated NCT02501759 - Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer N/A
Completed NCT01550783 - Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening N/A
Terminated NCT04179227 - Focus Group in Collecting Feedbacks From Indoor Tanning Bed Users for Social Media-Delivered Intervention Development
Active, not recruiting NCT03199209 - Your Health Matters! (Tu Salud ¡Si Cuenta!): Promoting Healthy Lifestyles in Latino Families N/A
Completed NCT00977392 - Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening N/A
Completed NCT00922285 - Art Therapy for Caregivers of Young Patients Undergoing Bone Marrow Transplant for Cancer N/A
Active, not recruiting NCT03441321 - Social-Media Intervention in Reducing Tanning in High-Risk Tanners N/A
Terminated NCT03412370 - Questionnaires and Cognitive Assessments Following Mammography
Completed NCT02264782 - PreView: The Preventive Video Education in Waiting Rooms Program N/A
Active, not recruiting NCT03674229 - Patients Navigators in Facilitating Weight Management in Obese Participants N/A
Completed NCT02355262 - CATCH-UP Intervention in Increasing Cancer Screening and Prevention Care in Uninsured Patients at Community Health Centers
Completed NCT02677012 - Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery
Completed NCT03115372 - Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans N/A
Completed NCT00897403 - Blood and Tissue Sample Collection for Future Colon Cancer Biomarker Studies in Patients Undergoing Colonoscopy N/A
Completed NCT04069923 - OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects N/A
Terminated NCT03688945 - Art in Improving Outcomes in Participants Undergo Surgery N/A
Withdrawn NCT00717535 - Studying Umbilical Cord Blood From African-American Donors N/A