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

NCT05737550 | Completed Results

• 1 other identifier: KCClin02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Abuse

Outcome Measures

Primary Outcomes (11)

• 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

  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

  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

  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

  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

  Day 0 (Visit 1)

• Usability Questionnaire - Question 10

  Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 10. How would you evaluate the study subject's ability to perform a Contraction Test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult

  Day 0 (Visit 1)

• Usability Questionnaire - Question 12.

  Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 12. How did the study subject experience keeping the phone still during the test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult

  Day 0 (Visit 1)

• Usability Questionnaire - Question 14.

  Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 14. In addition to the basic instructions, did the study subject need additional support performing tests with Previct Drugs? Response options: * Yes * No * Partly

  Day 0 (Visit 1)

• Usability Questionnaire - Question 16.

  Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 16. Was the study subject able to perform the test after receiving additional support? Response options: * Yes * No * Partly

  Day 0 (Visit 1)

• Usability Questionnaire - Question 17.

  Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 17. How many efforts did it take the study subject to perform test with Previct Drugs? Response options: * 1-2 times * 3-4 times * More than 4 times

  Day 0 (Visit 1)

• Usability Questionnaire - Question 18.

  Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 18. How likely do you think it is that the study subject will be able to perform tests with Previct Drugs without assistance in a home environment? Response options: * Very likely * Likely * Neither likely nor unlikely * Unlikely * Very unlikely

  Day 0 (Visit 1)

Secondary Outcomes (2)

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

  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.

  Up to 4 weeks post baseline

Study Arms (1)

Subjects with confirmed SUD

EXPERIMENTAL

Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).

Device: Previct Drugs

Interventions

Previct Drugs DEVICE

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.

Subjects with confirmed SUD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kontigo Care AB: lead

Study Sites (1)

Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa

Uppsala, Uppland, 75323, Sweden

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Markku Hämälainen, CSO
• Organization: Kontigo Care AB

markku.hamalainen@kontigocare.com

+46 (0)76 947 3132

Study Officials

• Markku Hämäläinen, PhD

  Kontigo Care AB

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigation aims to enroll up to 30 SUD subjects. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined. It is based on available subjects from the clinic.

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: March 10, 2023
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-07

Locations

SE (1)