Communicating Multiple Disease Risks

Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Cognitive interview; Other: Survey

• Study Type: Interventional
• Enrollment (Actual): 1191
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Cognitive Interviews; Participants will complete several survey items, view 1 of 8 disease risk pictures (selected at random), and then complete further survey questions.; Participants will then be recorded giving their opinions on the remaining 7 disease risk pictures which depict the hypothetical risk of disease.; The entire visit will take no more than 90 minutes with no follow-up.; The first 10-20 participants will be randomized to this arm.	Behavioral: Cognitive interview; Other: Survey
Experimental: Arm 2: Experimental survey; Participants will be randomly assigned by GfK's computer to one of the 12 experimental conditions.; After completing questions about information seeking and physical activity, the participants will read a short scenario that describes the purpose of a risk assessment tool and ask 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.	Other: Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Erika Waters, Ph.D., M.P.H., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): June 27, 2017
• Study Completion (Actual): June 27, 2017

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Other Study ID Numbers: 201501028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No