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Nudges to Improve Health Behaviors That Limit COVID-19 Spread

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379375
Recruitment Status : Terminated (Slow enrollment rate)
First Posted : May 7, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Advancing a Healthier Wisconsin Endowment
Information provided by (Responsible Party):
Nicholas D. Young, Medical College of Wisconsin

Brief Summary:
This investigation is a randomized intervention trial that evaluates behavioral nudges (BN) to increase hand washing behavior and subsequently reduce COVID-19 spreading to a targeted high-risk patient population based in Wisconsin.

Condition or disease Intervention/treatment Phase
Health Behavior COVID-19 Behavioral: Nudge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Behavioral Nudges to Improve Preventive Health Behaviors That Limit COVID-19 Spread
Actual Study Start Date : July 27, 2020
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Arm Intervention/treatment
Active Comparator: Inertia
Participants simply receive and subsequently have "default" access (i.e., readily and immediately available) to handwashing (HW) materials. This condition will functionally serve as a control comparison. As the term implies, inertia capitalizes on minimizing effort necessary (e.g., going to the grocery store) to engage in HW behavior in one's personal environment.
Behavioral: Nudge
Application of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables.

Experimental: Anchoring
Involves once again providing "default access" to HW materials as above, but adds an explicit written cue to wash hands at a rate of (15) times per day, which is placed directly on the soap dispenser. The stimulus is intended to deliberately prime participant thinking (and subsequent behavior) towards a higher reference point that "overshoots" a desired target rate of 10+ daily HWs.
Behavioral: Nudge
Application of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables.




Primary Outcome Measures :
  1. Hand Washing Behavior [ Time Frame: 8 weeks post-enrollment ]
    Measured via adapted version of a previously validated questionnaire (Hygiene Inventory - 23), which specifically includes (a) 1 item about approximate hand washing frequency on an average day, with response options of whole numbers from 0-29 and an additional option of "30 or more" where higher numbers are generally considered better outcomes, (b) 10 items about hand washing behavior in various contexts, with response options of "1 - Never", "2 - Occasionally", "3 - Usually", and "4 - Always" where higher scores are considered better outcomes, and (c) 1 item about general hand hygiene using antibacterial gel or wipes, with response options of "1 - Never", "2 - Occasionally", "3 - Usually", and "4 - Always" where higher scores are considered better outcomes.


Secondary Outcome Measures :
  1. Clinical Outcomes - General/Internal Medicine [ Time Frame: 12 weeks post-enrollment ]

    Patient frequency/rate for the following variables measured via electronic medical record:

    ED visit (respiratory illness/other) ED visit reason (if non-respiratory) Admission (respiratory Illness) Respiratory Illness secondary to COVID19 ICU admission due to respiratory illness ICU admission due to COVID19 Mechanical Respiratory support Duration of Mechanical support (days) Mortality (respiratory Illness/other)


  2. Clinical Outcomes - Obstetrics & Gynecology [ Time Frame: 12 weeks post-enrollment ]

    Patient frequency/rate for the following variables measured via electronic medical record:

    Respiratory Illness at time of Delivery Pre-delivery COVID19 testing Delivery plan altered due to respiratory illness Miscarriage Preterm labor/birth Preeclampsia Respiratory Illness in newborn Newborn COVID19 testing


  3. Clinical Outcomes - Surgery [ Time Frame: 12 weeks post-enrollment ]

    Patient frequency/rate for the following variables measured via electronic medical record:

    Respiratory Illness at time of surgery Pre-Operative COVID19 testing Surgery delayed due to respiratory illness Surgery delayed due to COVID19 positive Adverse outcome secondary to delay in surgery Post operative intubation >2 days Post operative unplanned reintubation Post operative pneumonia Post operative respiratory illness secondary to COVID19




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Provision of signed and dated informed consent form
  • Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  • Has at least 1 risk factor associated with COVID-19 documented in their electronic medical record
  • Followed by (i.e., actively receiving care) from targeted MCW specialties (Internal Medicine, OBGYN, Surgery)
  • Access to necessary resources for participating in a technology-based activities (i.e., internet access + mobile phone or computer to complete online survey)
  • Maintains a personal address where study materials can be shipped and where participant lives full time

Exclusion Criteria:

  • Previous COVID-19 diagnosis or positive COVID-19 test result documented in their electronic medical record
  • Current participation in another treatment or intervention study associated with COVID-19
  • Previous documented Obsessive-Compulsive Disorder diagnosis in their electronic medical record
  • Non-English speaker
  • Patients hospitalized or incapacitated at onset of potential enrollment
  • No access to electronic platform with internet (e.g., smartphone, tablet, computer)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379375


Locations
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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Advancing a Healthier Wisconsin Endowment
Investigators
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Principal Investigator: Nicholas D Young, PhD Medical College of Wisconsin
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Responsible Party: Nicholas D. Young, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04379375    
Other Study ID Numbers: PRO00037864
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No