Intrathecal Pump Refills at Home

Telemedicine Clinical Trial

Official title:

Feasibility, Safety and Effectiveness of Intrathecal Pump Refills at Home: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015933
• Other study ID #: ESCAPE
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: August 11, 2021

Study information

• Verified date: August 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 11, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Telemedicine

Intervention

Procedure:
• Pump refill procedure at home
Implantable pump refill is performed at home

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Primary	Successful pump refill	A binary variable to indicate success or failure of this intervention, reported by the physician.	Once, at the moment of the study visit, immediately after the pump refill
Primary	Patient safety	A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Primary	Physician safety	A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Environmental safety	An open question in which the physician can indicate whether there were any situations that were not safe.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Clean, sterile procedure	An open question in which the physician can mention all potential risks.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	An objective confirmation of correct injection in the pump by ultrasound.	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.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Adverse events	All adverse events will systematically be reported by the physician.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Patient feasibility	A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Quality of teleconsultant connection by teleconsultant	Quality of the internet connection will be evaluated by the teleconsultant.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Time burden for teleconsultant	The time will be measured from the beginning until the end of the call.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Physician feasibility	A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Quality of teleconsultant connection by physician	Quality of the internet connection will be evaluated by the physician.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Time burden for physician	The time will be measured from the beginning until the end of the call.	Once, at the moment of the study visit, immediately after the pump refill
Secondary	Patient preference	Patients will be asked to indicate whether they prefer to have their next refill at home.	Once, at the moment of the study visit, immediately after the pump refill