Efficiency Provision Process Assistive Devices for Donning and Doffing Compression Hosiery

NCT07636837 | Completed

• 1 other identifier: 80-87500-98-21103
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE:

1. 1.To optimize the process of providing assistive devices for donning and doffing compression hosiery.
2. 2.To evaluate effects and cost-effectiveness.

Conditions

Stockings, Compression

Keywords

Self-Help Devices; Doffing; Donning; Efficiency; Provision

Outcome Measures

Primary Outcomes (1)

• Adherence to the use of an assistive product for donning and/or doffing compression hosiery

  Use of the assistive device for donning and doffing compression hosiery, defined as percentage of days in 12 months (the duration of the study) on which participants don or doff their compression hosiery with the use of an assistive device. The percentage will be compared between both groups (intervention and control group (care as usual)). The use of assistive devices for donning and doffing compression hosiery will be measured every month during one week by means of a (digital or paper) diary. The digital diary can be filled in with the Samply app or Questback.

  12 months

Secondary Outcomes (7)

• D-QUEST (Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology)

  12 months

• IPPA

  12 months

• Autonomy

  12 months

• iPCQ

  12 months

• KWAZO [Kwaliteit van Zorg]

  12 months

Study Arms (2)

Optimized provision process

EXPERIMENTAL

Optimized method for the provision of assistive technology devices for doffing and donning compression hosiery.

Other: Optimized provision process

Care as usual

NO INTERVENTION

Care as usual

Interventions

Optimized provision process OTHER

The new method is developed based on a generic quality framework for the provision of AT in the Netherlands.

Optimized provision process

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years or older)
• Living at home
• Long-term indication for compression stockings with compression class II (23-32 mmHg), III (34-46 mmHg) and IV (\>46 mmHg)
• First delivery of the compression stockings
• Supplier estimates that donning/doffing without an assistive devise is difficult or impossible This group is heterogeneous regarding indication for compression stockings and secondary problems.

You may not qualify if:

• \< 18 years old
• Cognitive problems
• Difficulties to understand Dutch language
• Short-term indication for compression stockings
• Pregnancy

Sponsors & Collaborators

• Zuyd University of Applied Sciences: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Maastricht University: collaborator
• Erasmus Medical Center: collaborator
• Vilans: collaborator

Study Sites (1)

Zuyd University of Applied Sciences

Heerlen, Limburg, 6419 DJ, Netherlands

Location

Study Officials

• Ramon Daniels, PhD

  Zuyd UAS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: June 9, 2026
• Study Start: February 6, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Form March 6th 2026 until March 2041
• Access Criteria: Anonymized data is free available via DataVerse

Locations

NL (1)