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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with confirmed SUD | Experimental | Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| 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:
| 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:
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markku Hämäläinen, PhD | Kontigo Care AB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa | Uppsala | Uppland | 75323 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All eligible subjects = Full Analysis Set (FAS)
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Confirmed SUD | Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Full analysis set (FAS) | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
Through study completion, an average of 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Confirmed SUD | Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Markku Hämälainen, CSO | Kontigo Care AB | +46 (0)76 947 3132 | markku.hamalainen@kontigocare.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2022 | Nov 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2023 | Nov 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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|
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| Day 0 (Visit 1) |
| 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. | Up to 4 weeks post baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Timeline follow-back for drugs and alcohol. Question 1. | Question 1. How often do you use drugs other than alcohol?
| Count of Participants | Participants |
|
| Timeline follow-back for drugs and alcohol. Question 2. | Question 2. Do you use more than one drug on one occasion?
| Count of Participants | Participants |
|
| Timeline follow-back for drugs and alcohol. Question 3. | Question 3. How many times do you take drugs during a typical day when you use drugs?
| Count of Participants | Participants |
|
| Timeline follow-back for drugs and alcohol. Question 4. | Question 4. What have you consumed in the last 24 hours?
All applicable were to be checked. | Number | Participants consuming the listed drug |
|
| Timeline follow-back for drugs and alcohol. Question 5. | Question 5. How affected do you feel?
| Count of Participants | Participants |
|
| Timeline follow-back for drugs and alcohol. Question 6. | Question 6. What has the intake looked like during the last 24 hours compared to how it usually is?
| Count of Participants | Participants |
|
| Participants |
|
|
| Primary | 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:
| FAS | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Primary | 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:
| FAS | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Primary | 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:
| FAS | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Primary | 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:
| FAS. Analysis data missing for one subject. | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Primary | 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:
| FAS. Analysis data missing for one subject. | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Primary | 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:
| FAS. Analysis data missing for one subject. | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Primary | 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:
| FAS | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Primary | 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:
| FAS, the 10 subjects answering yes to usability question 14 (secondary endpoint 8) | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
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| Primary | 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:
| FAS | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Primary | 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:
| FAS | Posted | Count of Participants | Participants | Day 0 (Visit 1) |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Units | Number of tries | Up to 4 weeks post baseline | Number of tries | Number of tries |
|
|
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| Secondary | 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. | 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. | Posted | Count of Units | Number of tries | Up to 4 weeks post baseline | Number of tries | Number of tries |
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| 24 |
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| 24 |
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| Very difficult |
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| Difficult |
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| Very difficult |
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| Difficult |
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| Very difficult |
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| Difficult |
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| Very difficult |
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| Difficult |
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| Very difficult |
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| Difficult |
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| Very difficult |
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| Unlikely |
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| Very unlikely |
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| Successful tries - Horizontal nystagmus (NY) |
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| Successful tries - Tremor (TR) |
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| Successful tries - Pupillary light reflex (PLR) |
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| Successful tries - Redness (RED) |
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| Successful tries - Horizontal nystagmus (NY) |
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| Successful tries - Tremor (TR) |
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| Successful tries - Pupillary light reflex (PLR) |
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| Successful tries - Redness (RED) |
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