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Efficiency Provision Process Assistive Devices for Donning and Doffing Compression Hosiery

NCT07636837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-06-09

No results posted yet for this study

Summary

OBJECTIVE:

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

METHOD:

A cluster randomized controlled trial. Participants are recruited through the participating fitter of compression hosiery. The new method and associated tools will be developed in year 1 in 6 co-creation meetings with all stakeholders.

After development, the protocol is used by half of the participating suppliers of compression hosiery. For this purpose, a vocational training will be developed and provided in the project.

CARE AS USUAL:

Earlier research has provided insight into bottlenecks in the current method of providing devices for donning and doffing compression hosiery. Currently, the process is not standardized.

ECONOMIC EVALUATION:

According to Dutch guidelines as a combination of CEA and CUA from a societal perspective. Primary outcome measure CUA: incremental costs per extra QUALY based on the EQ-5D-5L. Costs healthcare, compression stockings user and family, as well as other costs (e.g. productivity) outside the healthcare sector will be included.

DISEASES:

The study population involves a heterogeneous group of individuals with various diseases such as chronic venous insufficiency, lymphedema, venous ulcer cruris, thrombosis.

HYPOTHESIS:

It is hypothesized that an optimized provision process with more involvement of users/wearers of compression hosiery, and better selection of assistive devices and training, positively contributes to compliance, satisfaction, independence, autonomy, participation and QoL of compression hosiery wearers. An optimized provision process is expected to be cost-effective.

Conditions

  • Stockings, Compression

Interventions

OTHER

Optimized provision process

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Vilans

    collaborator UNKNOWN

  • Zuyd University of Applied Sciences

    lead OTHER

Principal Investigators

  • Ramon Daniels, PhD · Zuyd UAS

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07636837 on ClinicalTrials.gov