Nudges to Improve Health Behaviors That Limit COVID-19 Spread

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Terminated
CT.gov ID
NCT04379375
Collaborator
Advancing a Healthier Wisconsin Endowment (Other)
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Study Details

Study Description

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
  • Behavioral: Nudge
N/A

Study Design

Study Type:
Interventional
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 :
Jul 27, 2020
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Hand Washing Behavior [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Medical College of Wisconsin
  • Advancing a Healthier Wisconsin Endowment

Investigators

  • Principal Investigator: Nicholas D Young, PhD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Oct 5, 2020
Last Verified:
Sep 1, 2020
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2020