- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02621671
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Missouri
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1: Cognitive Interviews
|
|
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Eksperimentel: Arm 2: Experimental survey
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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) .
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Completion of accrual for Arm 1 participants (estimated to be 1 year)
|
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Most effective combination of strategies in communicating multiple disease risk estimates (Arm 2 only)
Tidsramme: 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.
|
Completion of accrual for Arm 2 participants (estimated to be 1 year)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time that it takes to complete the survey that accompanies the images (Arm 1 only)
Tidsramme: Completion of accrual for first Arm 1 participants (estimated to be 1 year)
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-Verify that there are no issues with comprehension or interpretation that can cause the survey to go longer than 20 minutes.
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Completion of accrual for first Arm 1 participants (estimated to be 1 year)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Erika Waters, Ph.D., M.P.H., Washington University School of Medicine
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 201501028
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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