LymphAssistTM at Home (LAAH)

Status Completed

Clinical Trial Summary

Lymphoedema is a life-long condition causing long-term swelling affecting people physically, mentally and socially. Daily self-management covers four main areas (skin care, activity / movement, compression and massage / light touch). Intensive clinic-based treatments are available alongside usual care, including intermittent pneumatic compression (IPC). Recent studies have explored the feasibility, acceptability and impact of home-based IPC. This study will further our understanding of home-based IPC in a Value-Based procurement study.

Clinical Trial Description

Lymphoedema is a life-long condition causing long-term swelling. Lymphoedema mainly affects the extremities (arms / legs) and can occur at any age, affecting people physically, mentally and socially. Usual care focuses on life-long and daily self-management over four main areas (skin care, activity, compression and massage / light touch). Intensive clinic-based treatments are available alongside usual care. Intermittent pneumatic compression (IPC) helps move the lymph (fluid associated with the swelling) to offer comfort and reduce pain. Lymphoedema Services in Wales currently offer IPC in a clinic setting, despite reports suggesting that home use is helpful. To know more about this, this study will look to see if home use: - Improves clinical and patient reported outcomes - Is a good use of time and costs (efficient) - Provides benefits that outweigh the cost of buying the IPC equipment This study will recruit 40 patients with lymphoedema to use IPC daily at home for 12-weeks alongside their usual care. Information will be collected before and after the study including clinical measures (swelling, skin problems), patient reported outcomes (symptoms, quality of life) and experience. The study will compare the costs of procuring the IPC equipment with any benefits gained or costs avoided (less infections or hospital care). Participants will also be offered the chance to talk about their experiences of using IPC during an interview. Findings will be shared by publication and presentation. If the benefits are shown, lymphoedema services might be able to provide IPC for routine use at home through Value-Based procurement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05456568
Study type	Interventional
Source	Swansea Bay University Health Board
Contact
Status	Completed
Phase	N/A
Start date	July 6, 2022
Completion date	September 25, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

LymphAssistTM at Home (LAAH) — LAAH

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms