The Mobile Monitoring of Vital Signs in Opioid Users

NCT02647073 | Withdrawn

• 1 other identifier: H15-02986
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Opioid dependence and its associated harms are becoming increasingly prevalent in North America, with overdose now being the second leading cause of accidental death in the US. This pilot study will investigate the feasibility of a novel mobile device to monitor vital signs in both opioid-injecting individuals and hospital inpatients who are on high-dose oral opioids. A secondary goal is to explore associations between consumption and changes in vital signs post-injection with the long-term goal of developing a mobile system that will alert clinicians when patients are at risk of overdose so that appropriate interventions can be delivered in time.

Conditions

Opioid Use Disorders

Keywords

Mobile Monitoring; Post-Opioid Consumption; Vital Signs

Outcome Measures

Primary Outcomes (3)

• Participant compliance: Proportion of participants who wear the device

  Proportion of participants who wear the device for \>100 minutes per 120 minute session as reported by participants and observed by the study coordinator/nurse.

  For Visit 2, Visit 3 and Visit 4 (>100 minutes per 120minute session). Visits will take place over an average of 3 weeks

• Feasibility: Proportion of participant sessions with continuous transmission of vital signs data

  Proportion of participant sessions with continuous transmission of vital signs data for \>100 minutes per 120 minute session

  For Visit 2, Visit 3 and Visit 4( >100 minutes per 120 minute session). Visits will take place over an average of 3 weeks

• Clinical utility

  Compiled scores and summary data (means, medians, ranges) from participant \& clinician usability surveys.

  through study completion

Secondary Outcomes (5)

• Study retention and drop-out rates

  Through study completion, an average of 3 weeks per participant

• Premature device removal event counts and rates (participant or clinician initiated);

  Through study completion, an average of 3 weeks per participant.

• Reliability of device as measured by artefact and transmission failure rates;

  Through study completion, an average of 3 weeks per participant

• Characterization of physiological changes following opioid consumption;

  For Visit 2, Visit 3 and Visit 4 for 120 minutes. Visits will take place over an average of 3 weeks

• For a subset of participants enrolled in the hospital, accuracy of data recorded by the device in comparison to data collected by bedside monitoring equipment

  For Visit 2, Visit 3 and Visit 4 at various time points per 120 minute session.Visits will take place over an average of 3 weeks per participant.

Study Arms (1)

Mobile monitoring device arm

EXPERIMENTAL

Canary 01 Mobile Vital Signs Monitoring Device

Device: Canary 01 Mobile Vital Signs Monitoring Device

Interventions

Canary 01 Mobile Vital Signs Monitoring Device DEVICE

The prototype has several main components, including several commercially available sensors to measure heart rate, respiration, and motion data, an enclosed case containing circuitry for processing and transmitting data, and a mobile phone/system interface to store and transmit data.

Mobile monitoring device arm

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 64 years of age, inclusive;
• Current and ongoing injection drug use with opioids OR hospitalized inpatients under the care of the St. Paul's Hospital Addiction Medicine Consult Team with current and ongoing use of high dose oral opioid medications;
• Current and past history of an opioid use disorder;
• Ability to communicate in English; and
• Ability to provide written informed consent and comply with study procedures.

You may not qualify if:

• Inability to understand study procedures due to changed health and/or mental status;
• Chest circumference greater than 115 cm;
• Women who are pregnant or breastfeeding
• Has a pacemaker or automatic cardioverter defibrillator (AICD) in situ;
• Diagnosed with atrial fibrillation;
• Have other medical devices (i.e. insulin pump) that precludes the use of the device;
• Allergies or skin conditions that preclude the use of adhesive electrodes; and
• Any other condition that, in the judgment of the investigator, presents a contraindication to study participation.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Crosstown Community Clinic

Vancouver, British Columbia, V6B 1G8, Canada

Location

St Paul's Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Keith Ahamad

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Keith Ahmad

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 6, 2016
• Study Start: August 1, 2016
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)