Intrathecal Pump Refills at Home or at the Hospital
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Refill at the hospital, Refill at home.
- Who it may be relevant to
- Registry conditions: Intrathecal Pump Refill. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intrathecal Pump Refills at Home or at the Hospital: a Randomized Controlled Crossover Trial
Overview
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.
Interventions
- Procedure Refill at the hospital
Intrathecal pump refill procedure conducted at the hospital - Procedure Refill at home
Intrathecal pump refill procedure conducted at the home of the patient
Primary outcome measures
- Patient Comfort [Time frame: At baseline and immediately after each intervention.]
Secondary outcome measures (12)
- Quality of life [Time frame: At baseline and immediately after each intervention.]
- Health-related quality of life [Time frame: At baseline and immediately after each intervention.]
- Pain intensity [Time frame: At baseline and immediately after each intervention.]
- Pain interference [Time frame: At baseline and immediately after each intervention.]
- Stress [Time frame: 5 minutes before the refill, immediately after the refill and 10 minutes after the refill procedure.]
- Anxiety [Time frame: At baseline and immediately after each intervention.]
- Self-efficacy [Time frame: At baseline and immediately after each intervention.]
- Caregiver burden [Time frame: At baseline and immediately after each intervention.]
- Patient satisfaction [Time frame: Immediately after each refill procedure at home (intervention).]
- Tele-monitoring quality [Time frame: Immediately after each refill procedure at home (intervention).]
- Duration of refill [Time frame: Immediately after each intervention.]
- Safety of the refill procedure at home [Time frame: Immediately after each refill procedure at home (intervention).]
Eligibility criteria
Inclusion criteria
- Actively receiving Intrathecal drug delivery
- Stable medication dosage for at least 3 months
- Dutch, French or English speaking adults
Exclusion criteria
- Life expectancy < 6 months
- Patients planned for but not yet received Intrathecal drug delivery implant
- No residence in Belgium
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- UZ Brussel — Jette
Identifiers
NCT: NCT07727798 · 25242_IMPROVE