NCT06880692

Brief Summary

The goal of this work is to evaluate the use of ecological momentary assessments as a tool to assess risk and risk factors for tick encounters and tick-borne diseases. This study will be conducted across the United States, with a focus the upper Midwest and Northeast and with a focus on Wisconsin and will enroll up to 1000 people.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2020

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 10, 2025

Status Verified

October 1, 2025

Enrollment Period

6.1 years

First QC Date

March 11, 2025

Last Update Submit

October 8, 2025

Conditions

Keywords

tick educationbehavior changetick bite prevention

Outcome Measures

Primary Outcomes (1)

  • Change in number of tick prevention behaviors

    A goal of the intervention is to see an increase in tick prevention behaviors (tick checks and showering). To measure this, the change in number of tick prevention behaviors will be compared between groups. Data collected when participant completes 7 daily logs in app within 12 months.

    up to 12 months

Secondary Outcomes (1)

  • Change in number of self-reported tick encounters

    up to 12 months

Study Arms (2)

Tick App Educational Materials

EXPERIMENTAL
Other: Educational Materials delivered via the Tick App

No Educational Messaging

NO INTERVENTION

Interventions

Education about tick bite prevention

Tick App Educational Materials

Eligibility Criteria

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

You may qualify if:

  • Will to participate in 7 days worth of daily activity logs within the Tick App.
  • be able and willing to provide informed consent

You may not qualify if:

  • Completes less than 7 days worth of daily logs or completes 7+ daily logs but not within 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Illinois

Urbana, Illinois, 61801, United States

RECRUITING

Michigan State University

East Lansing, Michigan, 48824, United States

RECRUITING

Columbia University

New York, New York, 10027, United States

RECRUITING

Washington State University

Pullman, Washington, 99164, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Tick Bites

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Susan Paskewitz

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
  • Lyric Bartholomay

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassie Halvorsen

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants do not know if they are in the group getting messaging
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 18, 2025

Study Start

March 31, 2020

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

October 10, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Individual participant data collected during the trial, after the deidentification will be available to researchers for independent verification of study outcome or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Beginning 9 months after publication of primary outcomes and ending 2 years after that date.
Access Criteria
Proposals should be directed to Susan Paskewitz, smpaskew@wisc.edu or Maria Diuk Wasser, mad2256@columbia.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.

Locations