Assessing Patient Preference for Infusion Systems (Electronic vs. Mechanical)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- KORU Medical Systems, Inc.
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change in Patient Satisfaction Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Study Overview
Brief 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.
Detailed Description
Study Objective:
To assess patient preference, ease of training, ease of use, and satisfaction with mechanical versus electrical infusion pump systems.
Subject Population:
Adults with primary or secondary immunodeficiency receiving subcutaneous immunoglobulin therapy, including patients experienced with electronic infusion pumps.
Hypothesis:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experienced electronic pump users
Patients with earlier experience on electronic infusion pumps. They will use the mechanical infusion pump for three months' period.
Intervention: Mechanical infusion pump (Device)
Outcomes
Primary Outcomes
Change in Patient Satisfaction Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Time Frame: Three months
Participants will first provide a retrospective evaluation of their prior experience with an electronic infusion pump using a 5-point Likert scale (where 1 = worst outcome and 5 = best outcome). They will then crossover to a mechanical infusion pump for 3 months, after which satisfaction will again be assessed on the same scale. The primary outcome is the difference in satisfaction scores between electronic and mechanical pump use.
Secondary Outcomes
- Change in Ease of Use Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months(Three months)
- Change in Handling Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months(Three months)
- Change in Scores for Clarity of Instructions of Use Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months(Three months)
- Change in Scores for Ability for Troubleshooting Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months(Three months)
- Change in Scores for Pain and Discomfort Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months(Three months)