A Second Explorative Pilot Study Evaluating Usability and Functionality of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With Confirmed Substance Use Disorder (SUD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Usability Questionnaire - Question 4
研究概览
简要总结
This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participating in another clinical investigation which may affect the study outcome according to clinical judgement
- •Pregnancy or lactating
- •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
研究组 & 干预措施
Subjects with confirmed SUD
Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).
干预措施: Previct Drugs (Device)
结局指标
主要结局
Usability Questionnaire - Question 4
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 10
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 14.
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 16.
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 18.
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 1.
时间窗: Day 0 (Visit 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
Usability Questionnaire - Question 2
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 6
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 8
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 12.
时间窗: Day 0 (Visit 1)
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
Usability Questionnaire - Question 17.
时间窗: Day 0 (Visit 1)
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
次要结局
- 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)