- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07636837
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:
- 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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Limburg
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Heerlen, Limburg, 네덜란드, 6419 DJ
- Zuyd University of Applied Sciences
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 평소처럼 관리
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실험적: Optimized provision process
Optimized method for the provision of assistive technology devices for doffing and donning compression hosiery.
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The new method is developed based on a generic quality framework for the provision of AT in the Netherlands.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adherence to the use of an assistive product for donning and/or doffing compression hosiery
기간: 12 months
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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.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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D-QUEST (Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology)
기간: 12 months
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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
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IPPA
기간: 12 months
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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.
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12 months
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Autonomy
기간: 12 months
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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:
The main questions related to doffing are:
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12 months
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iPCQ
기간: 12 months
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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
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12 months
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KWAZO [Kwaliteit van Zorg]
기간: 12 months
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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.
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12 months
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EQ-5D-5L
기간: 12 Months
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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"
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12 Months
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iMCQ
기간: 12 months
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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.
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12 months
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공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Ramon Daniels, PhD, Zuyd UAS
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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