An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD

Kontigo Care AB24 enrolled

Overview

This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.

This second early feasibility study will give valuable information on the usability of Previct Drugs once being used in the intended population, i.e, patients with confirmed Substance Use Disorder (SUD). It will also give valuable information on the feasibility of Previct drugs function to measure pupils and eye movements in this population including evaluating the safety when using the device.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Drug Abuse

Interventions

Previct DrugsDEVICE

Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed Informed Consent Form * Male and female * A recurrent visitor at Sprututbytesprogrammet in Uppsala defined as visited the clinic within the last three (3) months * SUD in accordanve with DSM-5 criteria according to investigator/designee judgement * Age 18 and above * Negative urine pregnancy test for all fertile women * Been informed of the nature, the scope, and the relevance of the clinical investigation * Voluntarily agreed on participation and has duly singed the Informed Consent Form Exclusion Criteria: * Participating in another clinical investigation which may affect the study outcome according to clinical judgement * Pregnancy or lactating * Blind * Deaf * Any ECG dangerous arrythmia according to the investigator or designee judgement * Any disease or condition that may influence pupillary reflexes based on clinical judgement * Undergone eye surgery that may influence pupillary reflexes based on clinical judgement * Not able to read or understand the local language * Any planned travel or treatment which will make it impossible to participate according to the investigator or designee * Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate * That according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Locations (1)

Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa

Uppsala, Uppland, Sweden

Outcomes

Primary Outcomes

Usability Questionnaire - Question 1.

Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 1. Please evaluate the study subject's ability to use the mobile phone? Response options: * Good * Manageable * Less good

Time frame: Day 0 (Visit 1)

Usability Questionnaire - Question 2

Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 2. How did you perceive the study subject's ability to follow the instructions given by Previct Drugs? Response options: * Very good * Good * Either good or bad * Difficult * Very difficult

Time frame: Day 0 (Visit 1)

Usability Questionnaire - Question 4

Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 4. How did the study subject experience to put him/herself in the right position to be able to start a test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult

Time frame: Day 0 (Visit 1)

Usability Questionnaire - Question 6

Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 6. How would you evaluate the study subject's ability to perform a Cross-eyes test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult

Time frame: Day 0 (Visit 1)

Usability Questionnaire - Question 8

Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 8. How would you evaluate the study subject's ability to perform a Nystagmus test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult

Data from ClinicalTrials.gov

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Secondary Outcomes

Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder.

The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using native pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the native pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types.

Time frame: Up to 4 weeks post baseline

Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder.

The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using refined pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the refined pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types.

Time frame: Up to 4 weeks post baseline