Communicating Multiple Disease Risks

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02621671
Collaborator
(none)
1,191
1
2
26.9
44.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive interview
  • Other: Survey
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
1191 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
Actual Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jun 27, 2017
Actual Study Completion Date :
Jun 27, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 [Completion of accrual for Arm 1 participants (estimated to be 1 year)]

    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) .

  2. Most effective combination of strategies in communicating multiple disease risk estimates (Arm 2 only) [Completion of accrual for Arm 2 participants (estimated to be 1 year)]

    -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.

Secondary Outcome Measures

  1. Time that it takes to complete the survey that accompanies the images (Arm 1 only) [Completion of accrual for first Arm 1 participants (estimated to be 1 year)]

    -Verify that there are no issues with comprehension or interpretation that can cause the survey to go longer than 20 minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02621671
Other Study ID Numbers:
  • 201501028
First Posted:
Dec 3, 2015
Last Update Posted:
Nov 6, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine

Study Results

No Results Posted as of Nov 6, 2017