Intrathecal Pump Refills at Home or at the Hospital
ConditionIntrathecal Pump Refill
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMoens Maarten
About this trial
The IMPROVE study is a randomized, controlled, cross-over trial designed to compare intrathecal pump refills performed at home with those carried out in the hospital. Intrathecal drug delivery (IDD) is used in patients with chronic pain or severe spasticity. Use of IDD requires the performance of pump refills about 4-6 times a year which may be a burdensome and stressful experience for patients and their caregivers. Hospital visits can increase stress, pain, and caregiver strain, while early pilot studies suggest home-based refills may be both safe and more comfortable.
Eighty-two adult patients in Belgium with an implanted intrathecal pump will be enrolled in the IMPROVE study. Each participant will undergo four refill procedures: two at home and two at the hospital, in randomized order.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Actively receiving Intrathecal drug delivery
Stable medication dosage for at least 3 months
Dutch, French or English speaking adults
Disqualifiers
Life expectancy < 6 months
Patients planned for but not yet received Intrathecal drug delivery implant
No residence in Belgium
Trial design
Design model
Crossover
Treatments tested in this trial
Refill at the hospital
Procedure/SurgeryIntrathecal pump refill procedure conducted at the hospital
Refill at home
Procedure/SurgeryIntrathecal pump refill procedure conducted at the home of the patient
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Refill at homeActive comparator 1 intervention
Group B: Refill at the hospitalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Comfort
Patient comfort is evaluated with the General Comfort Questionnaire (GCQ), a self-reported instrument consisting of 48 items that reflect the physical, spiritual, environmental and social dimension. Responses are rated on a four-point Likert scale ranging from "strongly disagree" to "strongly agree". Some items are reverse scored during data processing, with higher overall scores indicating greater levels of comfort.
Time frame
At baseline and immediately after each intervention.Secondary outcomes
1
Quality of life
The McGill Quality of Life Questionnaire (MQOL) will measure quality of life and consists of 17 questions. Higher scores reflect a better quality of life.
Time frame
At baseline and immediately after each intervention.2
Health-related quality of life
The EuroQol with five dimensions and five levels (EQ-5D-5L) will be assessed to measure health-related quality of life. Higher scores reflect a better quality of life.
Time frame
At baseline and immediately after each intervention.3
Pain intensity
The Visual Analogue Scale (VAS - 100 mm) in electronic format will be used for the assessment of current pain intensity.
Time frame
At baseline and immediately after each intervention.4
Pain interference
The NIH-funded Patient-Reported Outcomes Measurement Information System Pain Interference measure assesses the impact of pain on key aspects of an individual's life. It evaluates the extent to which pain disrupts engagement in social, cognitive, emotional, physical, and recreational activities.
Time frame
At baseline and immediately after each intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Moens Maarten
Lead sponsor
Universitair Ziekenhuis Brussel
Sponsor institution
Source ClinicalTrials.gov