NCT05456568

LymphAssistTM at Home (LAAH)

Investigating Value-Based Procurement and Patient Reported Outcomes From Adults With Lymphoedema Using a 12-week Home-based Programme of LymphAssistTM (Intermittent Pneumatic Compression)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Swansea Bay University Health Board · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lymphedema Arm
• Lymphedema of Leg

Interventions

Type	Name	Description
DEVICE	LymphAssistTM Professional	An intermittent pneumatic compression (IPC) device that mimics manual lymphatic drainage. Participants use the device daily for 12 weeks alongside their usual and standard lymphoedema care

Timeline

• Start date: 2022-07-06
• Primary completion: 2023-09-25
• Completion: 2023-09-25
• First posted: 2022-07-13
• Last updated: 2023-10-30

Locations

1 site across 1 country: United Kingdom