Intrathecal Pump Refills at Home or at the Hospital (IMPROVE)

Intrathecal Pump Refills at Home or at the Hospital: a Randomized Controlled Crossover 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.

Study Overview

• Status: Recruiting
• Conditions: Intrathecal Pump Refill
• Intervention / Treatment: Procedure: Refill at home; Procedure: Refill at the hospital

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maarten Moens, MD PhD; Phone Number: +3224775514; Email: stimulusresearchgroup@gmail.com
• Study Contact Backup: Name: Lisa Goudman, PhD; Phone Number: +32472412507; Email: lisa.goudman@vub.be

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Maarten Moens, MD PhD
    • Sub-Investigator: Ulrike Van Hoey, MSc
    • Sub-Investigator: Britt Winnepenninckx, MSc
    • Sub-Investigator: Lisa Goudman, MSc, PhD
    • Sub-Investigator: Koen Putman, MSc, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Refill at home	Procedure: Refill at home; Intrathecal pump refill procedure conducted at the home of the patient
Active Comparator: Refill at the hospital	Procedure: Refill at the hospital; Intrathecal pump refill procedure conducted at the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and immediately after each intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and immediately after each intervention.
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.	At baseline and immediately after each intervention.
Pain intensity	The Visual Analogue Scale (VAS - 100 mm) in electronic format will be used for the assessment of current pain intensity.	At baseline and immediately after each intervention.
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.	At baseline and immediately after each intervention.
Stress	Saliva samples will be collected to measure cortisol levels with synthetic salivettes.	5 minutes before the refill, immediately after the refill and 10 minutes after the refill procedure.
Anxiety	Patient anxiety will be assessed through the State Trait Anxiety Inventory (STAI). This questionnaire consists of 40 Likert-type items on a four-point scale. Higher scores are indicating higher levels of anxiety.	At baseline and immediately after each intervention.
Self-efficacy	The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy.	At baseline and immediately after each intervention.
Caregiver burden	To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed. This 12-item self-report instrument assesses caregiver burden and is a shortened version of the original 22-item Zarit Burden Scale. The total score ranges from 0 to 48, with higher totals reflecting more significant caregiver burden.	At baseline and immediately after each intervention.
Patient satisfaction	Patient satisfaction is evaluated with a seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home.	Immediately after each refill procedure at home (intervention).
Tele-monitoring quality	The quality of tele-monitoring will only be evaluated after a home-filling. This will be examined using three different Likert scales to score 1) quality of audio, 2) quality of video, and 3) overall quality of the teleconsultation.	Immediately after each refill procedure at home (intervention).
Duration of refill	The time required for the full procedure will be recorded.	Immediately after each intervention.
Safety of the refill procedure at home	Patients will evaluate the overall safety of the procedure using a seven-point Likert scale. In addition, the researcher will assess safety on three levels: (1) overall perceived safety of the procedure using a seven-point Likert scale; (2) environmental safety, assessed through an open-ended question addressing any situations perceived as unsafe; and (3) the ability to perform the procedure in a clean and sterile manner, also evaluated via an open-ended question.	Immediately after each refill procedure at home (intervention).
Health expenditure	Expenditures related to in hospital care will be extracted from hospital claims data. All other healthcare-related costs will be gathered through telephone interviews with patients, conducted four weeks after the first and second medication refills. During these calls, researchers will ask patients whether they have had any medical consultations, hospital admissions, adverse events, changes in medication, or incurred any additional healthcare costs.	Four weeks after the first and second intervention.
Patient preference	After the fourth refill procedure, patients will be asked to indicate their preference (refill at home, refill in the hospital, no preference or other) for the location of their refills in the future.	Immediately after the final study intervention
Discrete choice experiment	After the fourth refill procedure, patients will be presented with a discrete choice experiment to evaluate their preferences across several scenarios.	Immediately after the final study intervention

Collaborators and Investigators

• Sponsor: Moens Maarten

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: telemedicine; neuromodulation; patient comfort; remote care; refill; Intrathecal drug delivery; intrathecal pump therapy; hospital to home transition
• Other Study ID Numbers: 25242_IMPROVE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No