Intrathecal pump refills at home or at the hospital

Intrathecal pump refills at home or at the hospital: a randomized controlled crossover trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18031921

Enrollment

Registered

2025-11-18

Start date

2025-10-15

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrathecal pump refill procedures Other

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Actively receiving Intrathecal drug delivery 2. Stable medication dosage for at least 3 months 3. Dutch, French or English speaking adults

Exclusion criteria

Exclusion criteria: 1. Life expectancy < 6 months 2. Patients planned for but not yet received Intrathecal drug delivery implant 3. No residence in Belgium

Design outcomes

Primary

Measure	Time frame
Patient Comfort measured using General Comfort Questionnaire (GCQ) at at baseline and after each of the four refill procedures (postprocedural) through study completion	—

Secondary

Measure	Time frame
Quality of life measured using the McGill Quality of Life Questionnaire (MQOL) at at baseline and after each of the four refill procedures (postprocedural) through study completion;Health-related quality of life measured using the EuroQol with five dimensions and five levels (EQ-5D-5L) at at baseline and after each of the four refill procedures (postprocedural) through study completion;Pain intensity measured using the Visual Analogue Scale (VAS - 100 mm) in electronic format at at baseline and after each of the four refill procedures (postprocedural) through study completion;Pain interference in social, cognitive, emotional, physical, and recreational activities measured using the NIH-funded Patient-Reported Outcomes Measurement Information System Pain Interference measure at at baseline and after each of the four refill procedures (postprocedural) through study completion;Stress measured using Saliva samples will be collected to measure cortisol levels with synthetic salivettes at 5 minutes before the refill, immediately after the refill and 10 minutes after the refill procedure.;Anxiety measured using the State Trait Anxiety Inventory (STAI). at at baseline and after each of the four refill procedures (postprocedural) through study completion;Self-efficacy measured using the General Self-Efficacy (GSE) Scale at at baseline and after each of the four refill procedures (postprocedural) through study completion;Caregiver burden measured using the Zarit Burden Interview (ZBI) questionnaire at at baseline and after each of the four refill procedures (postprocedural) through study completion;Patient satisfaction measured using seven-point Likert scale at after each of the four refill procedures (postprocedural) through study completion;Tele-monitoring quality measured using using three different Likert scales to score 1) quality of audio, 2) quality of video, and 3) overall quality of the teleconsultation at after each refill procedure at home (2 times);Duration of ref	—

Measure

Time frame

Quality of life measured using the McGill Quality of Life Questionnaire (MQOL) at at baseline and after each of the four refill procedures (postprocedural) through study completion;Health-related quality of life measured using the EuroQol with five dimensions and five levels (EQ-5D-5L) at at baseline and after each of the four refill procedures (postprocedural) through study completion;Pain intensity measured using the Visual Analogue Scale (VAS - 100 mm) in electronic format at at baseline and after each of the four refill procedures (postprocedural) through study completion;Pain interference in social, cognitive, emotional, physical, and recreational activities measured using the NIH-funded Patient-Reported Outcomes Measurement Information System Pain Interference measure at at baseline and after each of the four refill procedures (postprocedural) through study completion;Stress measured using Saliva samples will be collected to measure cortisol levels with synthetic salivettes at 5 minutes before the refill, immediately after the refill and 10 minutes after the refill procedure.;Anxiety measured using the State Trait Anxiety Inventory (STAI). at at baseline and after each of the four refill procedures (postprocedural) through study completion;Self-efficacy measured using the General Self-Efficacy (GSE) Scale at at baseline and after each of the four refill procedures (postprocedural) through study completion;Caregiver burden measured using the Zarit Burden Interview (ZBI) questionnaire at at baseline and after each of the four refill procedures (postprocedural) through study completion;Patient satisfaction measured using seven-point Likert scale at after each of the four refill procedures (postprocedural) through study completion;Tele-monitoring quality measured using using three different Likert scales to score 1) quality of audio, 2) quality of video, and 3) overall quality of the teleconsultation at after each refill procedure at home (2 times);Duration of ref

—

Countries

Belgium

Contacts

Public ContactLisa Goudman

lisa.goudman@vub.be+32 472412507

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026