NCT04350996

Brief Summary

The purpose the research is to demonstrate the feasibility of using a transdermal alcohol sensing device (BACtrack Skyn), and to correlate biological and self-reported alcohol measures with the transdermal alcohol measures in patients with a history of pancreatitis. The results from this study will inform tailored, self-directed interventions for reducing alcohol consumption in persons with pancreatitis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 15, 2020

Last Update Submit

April 28, 2020

Conditions

PancreatitisAlcohol Drinking

Keywords

Wearable technologyRemote monitoringPancreatitisContinuous alcohol monitoring

Outcome Measures

Primary Outcomes (1)

  • Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period

    Feasibility based on proportion of patients who wore the BACTrack sensor for at least 50% of study duration

    up to 14 days

Secondary Outcomes (5)

  • Acceptability of the BACtrack Skyn using the System Usability Scale (SUS)

    14 days

  • Blood alcohol concentration (BACtrack breathalyzer)

    up to 14 days

  • Patient-reported alcohol consumption

    up to 14 days

  • Urine alcohol consumption

    14 days

  • Patient-reported pain

    up to 14 days

Study Arms (1)

Continuous alcohol monitoring

Wearable BACtrack Skyn device

Other: Wearable alcohol sensor

Interventions

Wearable alcohol sensorOTHER

BACtrack Skyn, is a novel transdermal blood alcohol sensor developed by BACtrack, a company established for police-grade breathalyzers, and winner of the Wearable Alcohol Biosensor Challenge sponsored National Institute on Alcohol Abuse and Alcoholism.

Continuous alcohol monitoring

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients will have acute or chronic pancreatitis without calcification and have alcohol consumption score of ≥ 3 as measured using the validated TWEAK scale.

You may qualify if:

  • Aged 18-75 years at the time of eligibility assessment
  • History of at least one AP per Revised Atlanta Classification (20) within past 3 years from screening, which requires two of the following evidence of pancreatitis:
  • Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back)
  • Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal
  • Characteristic findings of AP on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI) or transabdominal ultrasonography
  • Access to a mobile or portable device that has the capability to sync to the BACtrack sensor and internet connection for syncing purposes.

You may not qualify if:

  • Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors.
  • Episode of acute pancreatitis requiring hospitalization in the past 4 weeks.
  • Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures.
  • Currently incarcerated.
  • Known pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

PancreatitisAlcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Central Study Contacts

Gillian Gresham Gresham, PhD

CONTACT

410-323-3341gillian.gresham@cshs.org

Felicity Pendergast, PhD

CONTACT

felicity.pendergast@cshs.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)