Assessing Patient Preference for Infusion Systems (NCT07189013) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessing Patient Preference for Infusion Systems
United Kingdom52 participantsStarted 2025-10-15
Plain-language summary
This crossover study evaluates patient experiences and preferences between mechanical and electrical infusion pumps for subcutaneous immunoglobulin (SCIg) therapy. The Freedom Integrated Infusion System (FREEDOM60 and FreedomEdge) are mechanical, portable pumps that require no batteries or electricity and use Precision Flow Rate Tubing™ to control infusion speed. These devices are approved for use in the EU (CE650520).
Approximately 78 adult patients with primary or secondary immunodeficiency will participate. Participants will complete questionnaires assessing ease of training, ease of use, infusion comfort, and overall satisfaction. Patients experienced with electronic pumps will complete two questionnaires: one reflecting their current pump experience and one after trying the mechanical pump.
The primary goal is to determine whether mechanical pumps provide greater patient satisfaction than electrical pumps. Results will inform patient and healthcare professional decision-making regarding pump selection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject has primary or secondary immunodeficiency or chronic inflammatory demyelinating polyneuropathy and is undergoing IgRT.
* The subject or caregiver is willing and able to provide informed consent.
* The subject has experience using electronic SCIG infusion system (3 months and above).
Exclusion Criteria:
* The subject is participating in another clinical study prior to this study completion.
* The subject has been on IgRT for less than 3 months.
* The subject is less than 18 years old and/or has a legal representative
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares electronic and mechanical infusion pumps for immunoglobulin therapy — can you explain how these two types of pumps differ in practice, and which one I'm currently using or would likely be assigned?
2Since this study is not yet recruiting, do you know when it's expected to open, and is there a reason I should wait for it rather than starting standard immunoglobulin infusion therapy now?
3The trial measures patient satisfaction over 3 months using a survey scale — does that mean my actual treatment with immunoglobulins would stay the same, and the only thing being studied is my experience with the pump device itself?
4Given that this is a preference and satisfaction study rather than a trial testing a new drug or dose, what are the potential risks or burdens I should weigh — like extra clinic visits, data collection, or changes to my infusion schedule?
5For my specific type of immunodeficiency, whether primary or secondary, does it matter which infusion pump system I use in terms of outcomes, and is there any existing evidence that one pump type is better suited to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient Satisfaction Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months