Communicating Multiple Disease Risks

Healthy Clinical Trial

Official title:

Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621671
• Other study ID #: 201501028
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2015
• Last updated: November 1, 2017
• Start date: April 1, 2015
• Est. completion date: June 27, 2017

Study information

• Verified date: November 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Epidemiology seeks to improve public health by identifying risk factors for cancer and other diseases and conveying that information to relevant audiences. The audience is presumed to understand and use that information to make appropriate decisions about lifestyle behaviors and medical treatments. Yet, even though a single risk factor can affect the risk of multiple health outcomes, this information is seldom communicated to people in a way that optimizes their understanding of the importance of engaging in a single healthy behavior. Providing individuals with the ability to understand how a single behavior (obtaining sufficient physical activity) could affect their risk of developing multiple diseases could foster a more coherent and meaningful picture of the behavior's importance in reducing health risks, increase motivation and intentions to engage in the behavior, and over time improve public health.

The proposed study translates epidemiological data about five diseases that cause significant morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes, and stroke) into a visual display that conveys individualized risk estimates in a comprehensible, meaningful, and useful way to diverse lay audiences.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1191
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• 30-65 years of age

• Able to read and communicate in English

• Not meeting national guidelines for aerobic physical activity (at least 150 minutes per week of moderate intensity aerobic physical activity)

Exclusion Criteria:

• Less than 30 years of age

• Older than 65 years of age

• Not able to read and communicate in English

• Meets national guidelines for aerobic physical activity (at least 150 minutes per week of moderate intensity aerobic physical activity)

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Cognitive interview

Other:
• Survey

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test eight images/visual displays that communicate risk estimates of five diseases associated with physical activity as measured by participants understanding of the images/visual displays	Survey questions will assess participants' cognitive and affective risk perceptions, response efficacy, perceived severity and reaction to the visual displays, health literacy and numeracy. The quantitative data will be examined using descriptive statistics (e.g., frequencies, mean, median, mode, range, interquartile range, standard deviation) to evaluate whether a potential variability problem exists (e.g., restricted range) .	Completion of accrual for Arm 1 participants (estimated to be 1 year)
Primary	Most effective combination of strategies in communicating multiple disease risk estimates (Arm 2 only)	-Participants will be randomly assigned by computer to 1 of the 12 experimental conditions. After completing questions about information seeking and physical activity they will read a short scenario that describes the purpose of a risk assessment tool and asks them to imagine that they had just entered their information into such a tool. Participants will see whichever risk ladder corresponds to the experimental condition to which they were assigned. The hypothetical display will be consistent with a display generated for an individual whose risk profile includes risk increasing and decreasing factors, but does not engage in the recommended amount of physical activity. To increase feasibility for the display will show the risk of the diseases in the same order regardless of experimental condition. Participants will be allowed to view the display as long as they wish.	Completion of accrual for Arm 2 participants (estimated to be 1 year)
Secondary	Time that it takes to complete the survey that accompanies the images (Arm 1 only)	-Verify that there are no issues with comprehension or interpretation that can cause the survey to go longer than 20 minutes.	Completion of accrual for first Arm 1 participants (estimated to be 1 year)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine