NCT04379375

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

May 4, 2020

Last Update Submit

September 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Clinical Outcomes - General/Internal Medicine

    12 weeks post-enrollment

  • Clinical Outcomes - Obstetrics & Gynecology

    12 weeks post-enrollment

  • Clinical Outcomes - Surgery

    12 weeks post-enrollment

Study Arms (2)

Inertia

ACTIVE COMPARATOR

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

Anchoring

EXPERIMENTAL

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

Interventions

NudgeBEHAVIORAL

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

AnchoringInertia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Health BehaviorCOVID-19

Condition Hierarchy (Ancestors)

BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nicholas D Young, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

July 27, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations