Implantable Pump, Intrathecal Drug Delivery, Telemedicine
Conditions
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.
Interventions
PROCEDUREPump refill procedure at home
Implantable pump refill is performed at home
Sponsors
Moens Maarten
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Belgium
Outcome results
None listed