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Not yet recruiting NCT07189013

Assessing Patient Preference for Infusion Systems

No phase Interventional Primary Immunodeficiencies (PID) Secondary Immunodeficiencies (SID)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mechanical infusion pump.
Who it may be relevant to
Registry conditions: Primary Immunodeficiencies (PID), Secondary Immunodeficiencies (SID). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Assessing Patient Preference for Infusion Systems (Electronic vs. Mechanical)

Overview

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:

Mechanical infusion pumps will provide greater patient satisfaction compared with electrical infusion pumps during SCIg treatment.

Study Assessments / Evaluations:

Experienced electronic pump users will complete two questionnaires: one reflecting their current pump experience and one after trying a mechanical pump. Comparisons will evaluate preference, satisfaction, ease of use, training, infusion comfort, handling, instructions, troubleshooting, and safety.

Number of Subjects:

Approximately 78 patients, completing 130 questionnaires in total.

Interventions

  • Device Mechanical infusion pump
    Patients with earlier experience on electronic infusion pumps will crossover to the mechanical infusion pump for three month's period

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Change in Ease of Use Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months [Time frame: Three months]
  • Change in Handling Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Three months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • King's College Hospital — London

Identifiers

NCT: NCT07189013 · KORU0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗