Autopen Injector Usability Study

Autopen Injector Usability Validation Study

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Observational
Eligible Ages: 18 - 100 Status: No Longer Recruiting
Time Since Diagnosis: Less than 60 years Study Focus:

Study Purpose:

People with Parkinson's disease and their caregivers are invited to participate in our Autopen Injector Usability Study. Caregivers may participate in the study with or without the person they help take care of.

This is a human factors or 'usability' study of a new pen injector for people with Parkinson's disease. The purpose of the study is to find out how easy or difficult it is to use the new injector. Participants will be compensated for their time and travel. The study session will last up to 180 minutes The study will take place in four cities on these dates: Louisville, KY- February 19th-22nd ,2018 Atlanta GA - February 19th-22nd ,2018 Houston TX - February 26th-March 1st, 2018 Orlando FL - February 26th-March 1st, 2018

More Details

This is a human factors or 'usability' study of a new pen injector for people with Parkinson's disease. The purpose of the study is to find out how easy or difficult it is to use the new injector. The study is being carried out by a contract research organization on behalf of a US pharmaceutical company. Potential participants in the study will include the following two groups: People with advanced Parkinson's, and Caregivers for people with advanced Parkinson's. Interested volunteers from each group will be asked a number of questions to determine if they meet specific criteria for inclusion in the study. Each study session will be up to 180 minutes long. For eligible participants, the study session will involve the following: 1. Introduction and informed consent 2. Training on how to use the pen injector* 3. Training decay period (a period of time between your training and testing) * 4. The study moderator will ask you to perform some tasks with the pen injector. This may include tasks such as opening packaging, using the pen injector and disposing of study components. 5. You will also be asked to answer some questions about the pen injector and its instructions. *You will be randomly assigned to a trained or untrained user group. If you are selected to the untrained group, your study session will not include training or training decay. It is important to note that the testing is not a drug trial: participants will not be asked to take any new medication or (in the case of caregivers and healthcare providers) to deliver a new medication to anyone else, and the injector will not be applied to any participant's body. The testing is carried out as a simulation by using an artificial skin pad to enable practice of the injection/ device attachment steps. Further, the testing is not an assessment of you or your Parkinson's disease, and it is not a test to find out if you are suitable for the new device. The testing is only designed to determine how usable the injector is in the hands of its intended user groups (patients, caregivers). Participation is confidential and your personal details will not be passed to the pharmaceutical company. Participants will be compensated for their time and travel. Dates for each city where the testing is being conducted are listed below -see the "Contact a Trial Team" section to contact a site representative. Louisville, KY- February 19th-22nd 2018 Atlanta GA - February 19th-22nd 2018 Houston TX - February 26th-March 1st, 2018 Orlando FL - February 26th-March 1st, 2018

Phase: Observational Lead Sponsor: US WorldMeds
Trial ID: 005147 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors: UserWise, Inc.
Estimated Enrollment: 60 Study Start Date: February 2018
Estimated Study Completion Date: March 2018 Source:
Study Website:
This Trial Offers Expanded Access This is a FDA Regulated Trial

More Inclusion & Exclusion Criteria

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