Nudges to Improve Health Behaviors That Limit COVID-19 Spread

COVID-19 Clinical Trial

Official title:

Using Behavioral Nudges to Improve Preventive Health Behaviors That Limit COVID-19 Spread

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04379375
• Other study ID #: PRO00037864
• Status: Terminated
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Health Behavior

Intervention

Behavioral:
• Nudge
Application of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Advancing a Healthier Wisconsin Endowment

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks post-enrollment
Secondary	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)	12 weeks post-enrollment
Secondary	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	12 weeks post-enrollment
Secondary	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	12 weeks post-enrollment