Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information
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.
Study Design
Allocation: Randomized
Conditions
Health Status Unknown
Intervention
counseling intervention, educational intervention
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00450931
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Health Behavior
Behaviors expressed by individuals to protect, maintain or promote their health status. For example, proper diet, and appropriate exercise are activities perceived to influence health status. Life style is closely associated with health behavior and factors influencing life style are socioeconomic, educational, and cultural.
Preconception Care
An organized and comprehensive program of health care that identifies and reduces a woman's reproductive risks before conception through risk assessment, health promotion, and interventions. Preconception care programs may be designed to include the male partner in providing counseling and educational information in preparation for fatherhood, such as genetic counseling and testing, financial and family planning, etc. This concept is different from PRENATAL CARE, which occurs during pregnancy.
Early Intervention (education)
Procedures and programs that facilitate the development or skill acquisition in infants and young children who have disabilities, who are at risk for developing disabilities, or who are gifted. It includes programs that are designed to prevent handicapping conditions in infants and young children and family-centered programs designed to affect the functioning of infants and children with special needs. (From Journal of Early Intervention, Editorial, 1989, vol. 13, no. 1, p. 3; A Discursive Dictionary of Health Care, prepared for the U.S. House of Representatives Committee on Interstate and Foreign Commerce, 1976)
Educational Status
Educational attainment or level of education of individuals.
Health Status Indicators
The measurement of the health status for a given population using a variety of indices, including morbidity, mortality, and available health resources.
Clinical Trials
RATIONALE: Printed educational materials and counseling by telephone may improve colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer. PURPOSE...
RATIONALE: The Clinical Effort Against Secondhand Smoke (CEASE) program may be more effective than standard care in increasing the number of parents who stop smoking. PURPOSE: This random...
This is a randomized clinical trial assessing the efficacy of two types of counseling (Computer-Assisted Motivational Intervention [CAMI] versus Didactic Educational Counseling [DEC]) to s...
RATIONALE: Clinic-based health programs may be effective in improving the diets and physical activity levels of low-income, uninsured participants in Los Angeles County, California. PURPO...
Partner Assistance in Learning and Performing Skin Self-Examination
This study is a behavioral science study designed to identify aspects of the dyadic relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing melanoma. T...
PubMed Articles
Cancer Knowledge Increases After a Brief Intervention Among Arab Americans in Michigan.
The objective of this study was to examine which factors are associated with increased cancer knowledge among a sample of 866 Arab Americans 40 years of age or older. Individuals were invited to atte...
Abstract Aspects of Latino culture (e.g., machismo, marianism) can act as barriers to enrollment in HIV-prevention programs. To lift these barriers, a culturally appropriate meta-intervention was desi...
The rapid Latino population growth in emerging Latino communities (EmLCs) presents a challenge to health care providers as most current health interventions and health promotion programs intended for...
The Impact of Asthma Health Education for Parents of Children Attending Head Start Centers.
Parents of children who attend Head Start Centers are key participants in the health promotion and care of their own children. This non-randomized, longitudinal study aimed to test the effectiveness o...
The purpose of the current study was to measure the effect of an educational intervention on the Health of the Nation Outcome Scales (HoNOS) completion rates. Additionally, interrater reliability and...
