Stockings, Compression#HASHTEKNCT07636837
Efficiency Provision Process Assistive Devices for Donning and Doffing Compression Hosiery
A study testing Optimized provision process in people with Stockings, Compression, run by Zuyd University of Applied Sciences at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stockings, Compression
- What is being tested?
- Optimized provision process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Feb 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- < 18 years old
- Cognitive problems
- Difficulties to understand Dutch language
- Short-term indication for compression stockings
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Zuyd University of Applied Sciences
Heerlen, Limburg, 6419 DJ
About this study
Official title: Efficiency of an Optimized Process of Providing Assistive Devices for Donning and Doffing Compression Hosiery
OBJECTIVE:
- To optimize the process of providing assistive devices for donning and doffing compression hosiery.
- To evaluate effects and cost-effectiveness.
Read more
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.
Read the detailed description
OBJECTIVE:
- 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.
- 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.
- Conditions
- Stockings, Compression
- Being tested
- Optimized provision process
- Keywords
- Self-Help Devices, Doffing, Donning, Efficiency, Provision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized provision processOther
The new method is developed based on a generic quality framework for the provision of AT in the Netherlands.
| Study group | Role | What they receive |
|---|---|---|
| Optimized provision process | Experimental | Optimized method for the provision of assistive technology devices for doffing and donning compression hosiery. Receives: Other: Optimized provision process |
| Care as usual | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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?
Measured: 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
Measured: 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.
Measured: 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"
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start6 Feb 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stockings, CompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyd University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Maastricht University, Erasmus Medical Center, Vilans
- Responsible party
- Principal investigator, Loek van der Heide, Zuyd University of Applied Sciences
- Investigators
- Ramon Daniels, PhD, Study director, Zuyd UAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636837
- Sponsor's protocol ID
- 80-87500-98-21103
- Acronym
- #HASHTEK
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of an Optimized Process of Providing Assistive Devices for Donning and Doffing Compression Hosiery
- ClinicalTrials.gov ID
- NCT07636837
- Acronym / sponsor ID
- #HASHTEK / 80-87500-98-21103
- Conditions
- Stockings, Compression
- Keywords
- Self-Help Devices, Doffing, Donning, Efficiency, Provision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Zuyd University of Applied SciencesUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Maastricht University, Erasmus Medical Center, Vilans
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE:
- To optimize the process of providing assistive devices for donning and doffing compression hosiery.
- 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.
Detailed description
OBJECTIVE:
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized provision process | Experimental | Other: Optimized provision processOptimized method for the provision of assistive technology devices for doffing and donning compression hosiery. |
| Care as usual | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- < 18 years old
- Cognitive problems
- Difficulties to understand Dutch language
- Short-term indication for compression stockings
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized provision processThe new method is developed based on a generic quality framework for the provision of AT in the Netherlands. | Other | Optimized provision process |
Primary outcome
Adherence to the use of an assistive product for donning and/or doffing compression hosiery
Time frame: 12 months
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.
7 secondary outcomes
D-QUEST (Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology)
Time frame: 12 months
IPPA
Time frame: 12 months
Autonomy
Time frame: 12 months
iPCQ
Time frame: 12 months
KWAZO [Kwaliteit van Zorg]
Time frame: 12 months
EQ-5D-5L
Time frame: 12 Months
iMCQ
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramon Daniels, PhD study director
Zuyd UAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized provision process in people with Stockings, Compression, run by Zuyd University of Applied Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the use of an assistive product for donning and/or doffing compression hosiery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.