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Набор скоро начнётся NCT07189013

Assessing Patient Preference for Infusion Systems

Без фазы С лечением Primary Immunodeficiencies (PID) Secondary Immunodeficiencies (SID)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mechanical infusion pump.
Кому может быть актуально
Состояния в реестре: Primary Immunodeficiencies (PID), Secondary Immunodeficiencies (SID). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Change in Patient Satisfaction Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months [Срок оценки: Three months]
Вторичные конечные точки (5)
  • Change in Ease of Use Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months [Срок оценки: Three months]
  • Change in Handling Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Three months]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • King's College Hospital — London

Идентификаторы

NCT: NCT07189013 · KORU0001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗