Intrathecal Pump Refills at Home

Not Applicable

Completed

• Conditions: Intrathecal Drug Delivery; Telemedicine; Implantable Pump
• Interventions: Procedure: Pump refill procedure at home

• Registration Number: NCT05015933
• Lead Sponsor: Moens Maarten

Brief Summary

The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-02
• Study Start: 2021-08-09
• Primary Completion: 2021-08-11
• Study Completion: 2021-08-11
• Study First Submitted QC: 2021-08-14
• Study First Posted: 2021-08-23
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient receives intrathecal drug therapy
• Patient is at least 18 years old
• Native French-or Dutch speaking persons.

Exclusion Criteria

• Patients < 18 years old.
• No native Dutch or French speaking persons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Refill at home	Pump refill procedure at home	Patients will have one pump refill at home instead of at the hospital.

Primary Outcome Measures

Name	Time	Method
Physician safety	Once, at the moment of the study visit, immediately after the pump refill	A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used.
Patient safety	Once, at the moment of the study visit, immediately after the pump refill	A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used.
Successful pump refill	Once, at the moment of the study visit, immediately after the pump refill	A binary variable to indicate success or failure of this intervention, reported by the physician.
Patient satisfaction	Once, at the moment of the study visit, immediately after the pump refill	A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used.

Secondary Outcome Measures

Name	Time	Method
Environmental safety	Once, at the moment of the study visit, immediately after the pump refill	An open question in which the physician can indicate whether there were any situations that were not safe.
Adverse events	Once, at the moment of the study visit, immediately after the pump refill	All adverse events will systematically be reported by the physician.
Quality of teleconsultant connection by physician	Once, at the moment of the study visit, immediately after the pump refill	Quality of the internet connection will be evaluated by the physician.
Time burden for physician	Once, at the moment of the study visit, immediately after the pump refill	The time will be measured from the beginning until the end of the call.
An objective confirmation of correct injection in the pump by ultrasound.	Once, at the moment of the study visit, immediately after the pump refill	After the refill procedure is performed, an ultrasound will be made to visually ensure that the refill was correctly performed without loss of liquor outside the pump.
Patient feasibility	Once, at the moment of the study visit, immediately after the pump refill	A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used.
Quality of teleconsultant connection by teleconsultant	Once, at the moment of the study visit, immediately after the pump refill	Quality of the internet connection will be evaluated by the teleconsultant.
Physician feasibility	Once, at the moment of the study visit, immediately after the pump refill	A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used.
Time burden for teleconsultant	Once, at the moment of the study visit, immediately after the pump refill	The time will be measured from the beginning until the end of the call.
Patient preference	Once, at the moment of the study visit, immediately after the pump refill	Patients will be asked to indicate whether they prefer to have their next refill at home.
Clean, sterile procedure	Once, at the moment of the study visit, immediately after the pump refill	An open question in which the physician can mention all potential risks.

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Belgium