LymphAssistTM at Home (LAAH)

Swansea Bay University Health Board

Status

Completed

Conditions

Lymphedema Arm

Lymphedema of Leg

Treatments

Device: LymphAssistTM Professional

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05456568

LymphAssist at home Protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed diagnosis of lymphoedema (either primary or secondary) affecting lower or upper limbs
Known to local lymphoedema services and receiving ongoing treatment for their lymphoedema
Age 18 and over
Able to given informed written consent
Able to safely use the Pump, following written and / or verbal instruction in English or Welsh

Exclusion criteria

Cognitive impairment / unable to safely use the Pump at home
Truncal / root of extremity oedema
Known or suspected deep vein thrombosis
Known or suspected pulmonary embolism
Thrombophlebitis
Active or suspected cellulitis
Severe peripheral neuropathy
Uncontrolled or severe congestive heart failure
Pulmonary oedema
Ischaemic vascular disease
Active cancer / metastases affecting the area of lymphoedema / undergoing cancer treatment
Untreated ulcer / wounds
Urinary of faecal incontinence (for patients with lower limb lymphoedema only)
History of clostridium difficile
Unable to communicate in English or Welsh