Trial Outcomes & Findings for An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD (NCT NCT05737550)

Last Updated: 2024-10-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

Day 0 (Visit 1)

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Confirmed SUD Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD). Previct Drugs: 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.
Overall Study STARTED	24
Overall Study Visit 2 (Follow-up Visit 1)	11
Overall Study Visit 3 (Follow-up Visit 2)	5
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Confirmed SUD n=24 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Age, Continuous	39.9 years STANDARD_DEVIATION 11.5 • n=24 Participants
Sex: Female, Male Female	12 Participants n=24 Participants
Sex: Female, Male Male	12 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 1. Never	0 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 1. Once a month or less often	0 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 1. 2-4 times per month	1 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 1. 2-3 times per week	2 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 1. 4 times per week or more often	21 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 2. Never	4 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 2. Once a month or less often	1 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 2. 2-4 times per month	5 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 2. 2-3 times per week	2 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 2. 4 times per week or more often	12 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 3. 0	0 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 3. 1-2 times	3 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 3. 3-4 times	11 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 3. 5-6 times	7 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 3. 7 or more	3 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 4. Alcohol	8 Participants consuming the listed drug n=24 Participants
Timeline follow-back for drugs and alcohol. Question 4. BZ/Sleeping pills than alcohol?	10 Participants consuming the listed drug n=24 Participants
Timeline follow-back for drugs and alcohol. Question 4. Hashish, cannabis	9 Participants consuming the listed drug n=24 Participants
Timeline follow-back for drugs and alcohol. Question 4. Amphetamine, cocaine, ectasy	18 Participants consuming the listed drug n=24 Participants
Timeline follow-back for drugs and alcohol. Question 4. Morphone, heroine, buprenorphine, fentanyl, codeine, tramadol	13 Participants consuming the listed drug n=24 Participants
Timeline follow-back for drugs and alcohol. Question 4. Other	2 Participants consuming the listed drug n=24 Participants
Timeline follow-back for drugs and alcohol. Question 5. Not affected	5 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 5. Little affected	18 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 5. Affected	1 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 5. Very affected	0 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 6. More than usual	4 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 6. As much as usual	13 Participants n=24 Participants
Timeline follow-back for drugs and alcohol. Question 6. Less than usual	7 Participants n=24 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: Full analysis set (FAS)

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=24 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 1. Good	16 Participants
Usability Questionnaire - Question 1. Manageble	7 Participants
Usability Questionnaire - Question 1. Less good	1 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=24 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 2 Very good	5 Participants
Usability Questionnaire - Question 2 Good	11 Participants
Usability Questionnaire - Question 2 Either good or bad	6 Participants
Usability Questionnaire - Question 2 Difficult	2 Participants
Usability Questionnaire - Question 2 Very difficult	0 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=24 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 4 Difficult	4 Participants
Usability Questionnaire - Question 4 Very difficult	3 Participants
Usability Questionnaire - Question 4 Very easy	2 Participants
Usability Questionnaire - Question 4 Easy	12 Participants
Usability Questionnaire - Question 4 Either easy or difficult	3 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=24 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 6 Very easy	4 Participants
Usability Questionnaire - Question 6 Easy	9 Participants
Usability Questionnaire - Question 6 Either easy or difficult	3 Participants
Usability Questionnaire - Question 6 Difficult	6 Participants
Usability Questionnaire - Question 6 Very difficult	2 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS. Analysis data missing for one subject.

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=23 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 8 Very easy	10 Participants
Usability Questionnaire - Question 8 Easy	7 Participants
Usability Questionnaire - Question 8 Either easy or difficult	3 Participants
Usability Questionnaire - Question 8 Difficult	3 Participants
Usability Questionnaire - Question 8 Very difficult	0 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS. Analysis data missing for one subject.

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=23 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 10 Very easy	5 Participants
Usability Questionnaire - Question 10 Easy	8 Participants
Usability Questionnaire - Question 10 Either easy or difficult	2 Participants
Usability Questionnaire - Question 10 Difficult	5 Participants
Usability Questionnaire - Question 10 Very difficult	3 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS. Analysis data missing for one subject.

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=23 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 12. Very easy	3 Participants
Usability Questionnaire - Question 12. Easy	15 Participants
Usability Questionnaire - Question 12. Either easy or difficult	2 Participants
Usability Questionnaire - Question 12. Difficult	2 Participants
Usability Questionnaire - Question 12. Very difficult	1 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=24 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 14. Yes	10 Participants
Usability Questionnaire - Question 14. No	14 Participants
Usability Questionnaire - Question 14. Partly	0 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS, the 10 subjects answering yes to usability question 14 (secondary endpoint 8)

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=10 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 16. Yes	8 Participants
Usability Questionnaire - Question 16. No	1 Participants
Usability Questionnaire - Question 16. Partly	1 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=24 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 17. 1-2 times	19 Participants
Usability Questionnaire - Question 17. 3-4 times	4 Participants
Usability Questionnaire - Question 17. More than 4 times	1 Participants

PRIMARY outcome

Timeframe: Day 0 (Visit 1)

Population: FAS

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

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=24 Participants Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Usability Questionnaire - Question 18. Very likely	8 Participants
Usability Questionnaire - Question 18. Likely	8 Participants
Usability Questionnaire - Question 18. Neither likely nor unlikely	4 Participants
Usability Questionnaire - Question 18. Unlikely	3 Participants
Usability Questionnaire - Question 18. Very unlikely	1 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks post baseline

Population: All tries documented for each of the measurements; pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED), for the FAS population.

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.

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=92 Number of tries Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. Successful tries - Non-convergence (NC)	40 Number of tries
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. Successful tries - Horizontal nystagmus (NY)	23 Number of tries
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. Successful tries - Tremor (TR)	39 Number of tries
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. Successful tries - Pupillary light reflex (PLR)	79 Number of tries
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. Successful tries - Redness (RED)	84 Number of tries

SECONDARY outcome

Timeframe: Up to 4 weeks post baseline

Population: All tries documented for each of the measurements; pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED), for the FAS population.

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.

Outcome measures

Outcome measures
Measure	Subjects With Confirmed SUD n=92 Number of tries Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. Successful tries - Non-convergence (NC)	40 Number of tries
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. Successful tries - Horizontal nystagmus (NY)	23 Number of tries
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. Successful tries - Tremor (TR)	39 Number of tries
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. Successful tries - Pupillary light reflex (PLR)	79 Number of tries
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. Successful tries - Redness (RED)	84 Number of tries

Adverse Events

Subjects With Confirmed SUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Markku Hämälainen, CSO

Kontigo Care AB

Phone: +46 (0)76 947 3132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60