Intrathecal Pump Refills at Home

Study Overview
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Brief Summary
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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.

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

Conditions
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Intrathecal Drug Delivery, Implantable Pump, Telemedicine

Intervention / Treatment
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* Procedure: Pump refill procedure at home


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refill at home<br>Patients will have one pump refill at home instead of at the hospital. | Procedure: Pump refill procedure at home<br>* Implantable pump refill is performed at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |