Communicating Multiple Disease Risks

NCT02621671 | Completed Phase 1

• 1 other identifier: 201501028
• Study Type: interventional
• Target: 1,191
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (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)

Study Arms (2)

Arm 1: Cognitive Interviews

EXPERIMENTAL

* 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

Arm 2: Experimental survey

EXPERIMENTAL

* 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

Interventions

Cognitive interview BEHAVIORAL

Arm 1: Cognitive Interviews

Survey OTHER

Arm 1: Cognitive Interviews; Arm 2: Experimental survey

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Erika Waters, Ph.D., M.P.H.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 3, 2015
• Study Start: April 1, 2015
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)