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COMPLETED
NCT07636837
NA

Efficiency Provision Process Assistive Devices for Donning and Doffing Compression Hosiery

Sponsor: Zuyd University of Applied Sciences

View on ClinicalTrials.gov

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.

Official title: Efficiency of an Optimized Process of Providing Assistive Devices for Donning and Doffing Compression Hosiery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2023-02-06

Completion Date

2025-04-01

Last Updated

2026-06-09

Healthy Volunteers

No

Interventions

OTHER

Optimized provision process

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

Locations (1)

Zuyd University of Applied Sciences

Heerlen, Limburg, Netherlands