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Nudges to Improve Health Behaviors That Limit COVID-19 Spread

Primary Purpose

Health Behavior, COVID-19

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nudge
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Inertia

Anchoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hand Washing Behavior
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

Clinical Outcomes - General/Internal Medicine
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)
Clinical Outcomes - Obstetrics & Gynecology
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
Clinical Outcomes - Surgery
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

Full Information

First Posted
May 4, 2020
Last Updated
September 30, 2020
Sponsor
Medical College of Wisconsin
Collaborators
Advancing a Healthier Wisconsin Endowment
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1. Study Identification

Unique Protocol Identification Number
NCT04379375
Brief Title
Nudges to Improve Health Behaviors That Limit COVID-19 Spread
Official Title
Using Behavioral Nudges to Improve Preventive Health Behaviors That Limit COVID-19 Spread
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment rate
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Advancing a Healthier Wisconsin Endowment

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior, COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inertia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Anchoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nudge
Intervention Description
Application of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables.
Primary Outcome Measure Information:
Title
Hand Washing Behavior
Description
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.
Time Frame
8 weeks post-enrollment
Secondary Outcome Measure Information:
Title
Clinical Outcomes - General/Internal Medicine
Description
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)
Time Frame
12 weeks post-enrollment
Title
Clinical Outcomes - Obstetrics & Gynecology
Description
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
Time Frame
12 weeks post-enrollment
Title
Clinical Outcomes - Surgery
Description
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
Time Frame
12 weeks post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas D Young, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nudges to Improve Health Behaviors That Limit COVID-19 Spread

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