Health BehaviorNCT04379375
Nudges to Improve Health Behaviors That Limit COVID-19 Spread
A study testing Nudge in people with Health Behavior and COVID-19, run by Medical College of Wisconsin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, COVID-19
- What is being tested?
- Nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Using Behavioral Nudges to Improve Preventive Health Behaviors That Limit COVID-19 Spread
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.
- Conditions
- Health Behavior, COVID-19
- Being tested
- Nudge
- Medical subject headings
- Health Behavior, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
Application of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks post-enrollment
Secondary outcomes (3)
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)
Measured: 12 weeks post-enrollment
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
Measured: 12 weeks post-enrollment
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
Measured: 12 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start27 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Why it stopped: Slow enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Advancing a Healthier Wisconsin Endowment
- Responsible party
- Principal investigator, Nicholas D. Young, Medical College of Wisconsin
- Investigators
- Nicholas D Young, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379375
- Sponsor's protocol ID
- PRO00037864
- Status last verified
- Sep 2020
- First submitted
- 4 May 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Nudges to Improve Preventive Health Behaviors That Limit COVID-19 Spread
- ClinicalTrials.gov ID
- NCT04379375
- Acronym / sponsor ID
- PRO00037864
- Conditions
- Health Behavior, COVID-19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment rate
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Advancing a Healthier Wisconsin Endowment
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inertia | Active comparator | Behavioral: NudgeParticipants 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. |
| Anchoring | Experimental | Behavioral: NudgeInvolves 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NudgeApplication of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables. | Behavioural | Anchoring, Inertia |
Primary outcome
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.
3 secondary outcomes
Clinical Outcomes - General/Internal Medicine
Time frame: 12 weeks post-enrollment
Clinical Outcomes - Obstetrics & Gynecology
Time frame: 12 weeks post-enrollment
Clinical Outcomes - Surgery
Time frame: 12 weeks post-enrollment
Results and safety
The study was stopped early (reason given: Slow enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas D Young, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge in people with Health Behavior and COVID-19, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Washing Behavior (time frame: 8 weeks post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.