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

2026年6月3日 更新者:Loek van der Heide、Zuyd University of Applied Sciences

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

220

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Limburg
      • Heerlen、Limburg、オランダ、6419 DJ
        • Zuyd University of Applied Sciences

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
介入なし:いつものケア
実験的:Optimized provision process
Optimized method for the provision of assistive technology devices for doffing and donning compression hosiery.
The new method is developed based on a generic quality framework for the provision of AT in the Netherlands.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Adherence to the use of an assistive product for donning and/or doffing compression hosiery
時間枠: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.
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
D-QUEST (Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology)
時間枠:12 months

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
時間枠:12 months
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
時間枠:12 months

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
時間枠:12 months
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]
時間枠:12 months
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
時間枠:12 Months
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
時間枠:12 months
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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディディレクター:Ramon Daniels, PhD、Zuyd UAS

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年2月6日

一次修了 (実際)

2025年4月1日

研究の完了 (実際)

2025年4月1日

試験登録日

最初に提出

2023年3月20日

QC基準を満たした最初の提出物

2026年6月3日

最初の投稿 (実際)

2026年6月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月9日

QC基準を満たした最後の更新が送信されました

2026年6月3日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 80-87500-98-21103

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

Form March 6th 2026 until March 2041

IPD 共有アクセス基準

Anonymized data is free available via DataVerse

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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