Efficiency Provision Process Assistive Devices for Donning and Doffing Compression Hosiery (#HASHTEK)

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

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.

Study Overview

• Status: Completed
• Conditions: Stockings, Compression
• Intervention / Treatment: Other: Optimized provision process

Detailed Description

OBJECTIVE:

1. To optimize the process of providing assistive devices for donning and doffing compression hosiery, resulting in a better quality of life (QoL) for users of compression stockings, less burden on informal caregivers and homecare and substantial savings in healthcare costs.
2. To evaluate effects and cost-effectiveness.

METHOD:

A cluster randomized controlled trial, controlled trial with a 1:1 allocation of participants in the intervention and in the control group. Participants in both groups are recruited through the participating fitter of compression hosiery. The recruiters in the intervention group work together with occupational therapists according to the developed optimized method for the providing process. The new method and associated tools will be developed in year 1 in 6 co-creation meetings with all stakeholders.

The new method follows the steps described in the RiFA and will be defined in a protocol. After development, the protocol is used by half of the participating suppliers of compression hosiery and the occupational therapists with whom they collaborate. For this purpose, a vocational training will be developed and provided in the project, and the protocol and associated tools will be made available digitally.

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; not everyone who would benefit is entering the process, professionals do not have sufficient knowledge about the assistive devices, the cooperation between client, supplier and care professional often does not go well, the match between the device, client and environment is often not sufficient, reimbursement is not adequate and the evaluation is limited.

ECONOMIC EVALUATION:

According to Dutch guidelines as a combination of CEA and CUA from a societal perspective. In the CEA, the ICER is expressed as the incremental costs per improvement on the success rate. 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. All relevant data are collected with a tailored cost questionnaire.

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 stockings, and better selection of assistive devices and training, positively contributes to compliance, satisfaction, independence, autonomy, participation and QoL of compression hosiery users/wearers. In addition, an optimized provision process is expected to be cost-effective. In the short term, this will lead to higher costs for services and assistive devices (e.g., additional use of occupational therapy for selection of the devices, instruction and training, possibly provision of more expensive devices and careful evaluation), but the costs of home care (and indirect costs for informal care) and the treatment of complications will decrease.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419 DJ
      • Zuyd University of Applied Sciences

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Care as usual
Experimental: Optimized provision process; Optimized method for the provision of assistive technology devices for doffing and donning compression hosiery.	Other: Optimized provision process; The new method is developed based on a generic quality framework for the provision of AT in the Netherlands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
D-QUEST (Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology)	The Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) measures the satisfaction of an assistive technology user with a provided assistive device. The Dutch version consists of 12 items that are scored on a 5-point scale. 1= not satisfied at all and 5 = very satisfied. Users are asked to indicate how satisfied or dissatisfied they are with each aspect. Respondents can indicate their degree of satisfaction or dissatisfaction with the various aspects using the multiple-choice answers below. If they are not satisfied, they will be asked for the reason why (free text field). A high score on the D-QUEST corresponds to a high level of satisfaction. The D-QUEST can be used at an individual level as a "clinical instrument" to evaluate an individual provision. In other words, as part of the care process and with the aim of optimizing that provision.	12 months
IPPA	Individually Prioritised Problem Assessment (IPPA) assesses the effectiveness of assistive technology provision. It is a generic instrument that can be used to assess the extent to which problems identified by an individual assistive technology user have been diminished. This study only asks about the activities of donning and doffing compression hosiery. At the start of the service delivery process, the client is asked to identify and rate the problems with donning and doffing the compression hosiery (no difficulty at all= 1, too much difficulty to perform = 5), and the importance of the activity (not relevant = 1, very relevant = 5). The same activities are rated again, a few months after receiving a new assistive technology. It measures the reduction in problems experienced during daily activities before and after the provision of the device, in this case donning CH. A negative score indicates that the problems have worsened. A positive score indicates the problems have decreased.	12 months
Autonomy	The in-house developed questionnaire on autonomy covers six main questions, three relating to donning and three to doffing. For each main question, respondents are asked whether they can decide on this themselves. If the answer is no or not always, they are asked whether this is caused by donning or doffing CH. Respondents are only asked to what extent they experience this as a problem if the answer to the previous question is yes. The main questions related to donning: Can you decide for yourself what time you get up?; Can you decide how you spend your morning if you stay at home?; Can you participate in planned activities outside the home in the morning? The main questions related to doffing are: Can you decide what time you go to bed?; Can you decide how to spend your evenings if you stay at home?; Can you take part in organized activities outside the home in the evening?	12 months
iPCQ	The iMTA Productivity Cost Questionnaire (iPCQ) asks questions on time spent with (unpaid) work, absenteeism and support of informal caregivers for unpaid work/productivity during the last 4 weeks	12 months
KWAZO [Kwaliteit van Zorg]	KWAZO [Kwaliteit van Zorg; Quality of Care] is a questionnaire to assess the quality of an assistive technology provision process from a client's perspective. KWAZO has decent measurement properties, and its self-report format makes it an easy-to-use tool for assessment of the quality of assistive technology provision. The KWAZO asks seven questions about patient satisfaction with the process of providing medical aids. Patients can answer the questions with "inadequate = 1" "adequate = 2", or "good =3". Total score: wise score (7-21), where a high score indicates a high degree of satisfaction with the device provided.	12 months
EQ-5D-5L	Health-related quality of life is measured using the EuroQol EQ-5D-5L questionnaire at baseline and three follow-up time points (T0-T3). Responses across the five EQ-5D dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The EQ-5D-5L consists of five items. For each item, participants rated the extent of their problems from "no problems =1" to "extreme problems = 5"	12 Months
iMCQ	The iMTA Medical Consumption Questionnaire (iMCQ) is an instrument for measuring medical consumption. The iMCQ includes questions on type and number of appointments with health care professionals in the last 4 months, type and number of received treatment, support or other social and health care interventions. The iMCQ is a generic questionnaire. It is therefore not disease specific. In other words, reference is made to healthcare consumption due to illness, disability or psychiatric problems, without specifying a particular disease.	12 months

Collaborators and Investigators

• Sponsor: Zuyd University of Applied Sciences
• Collaborators: Erasmus Medical Center; Maastricht University; ZonMw: The Netherlands Organisation for Health Research and Development; Vilans
• Investigators: Study Director: Ramon Daniels, PhD, Zuyd UAS

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Efficiency; Self-Help Devices; Doffing; Donning; Provision
• Other Study ID Numbers: 80-87500-98-21103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD plan description: Individual clinical trial participant-level data will be published open access anonymously. Data with pseudonyms will be sent on request on certain conditions.
• IPD Sharing Time Frame: Form March 6th 2026 until March 2041
• IPD Sharing Access Criteria: Anonymized data is free available via DataVerse
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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