Clinical trial NCT05456568: LymphAssistTM at Home (LAAH)
Official title: Investigating Value-Based Procurement and Patient Reported Outcomes From Adults With Lymphoedema Using a 12-week Home-based Programme of LymphAssistTM (Intermittent Pneumatic Compression)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema Arm
Lymphedema of Leg
Lead sponsor: Swansea Bay University Health Board
Sponsor class: OTHER
Collaborators: name: Lymphoedema Wales Clinical Network
name: Swansea University
name: Huntleigh Healthcare Ltd
First posted: 2022-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Lymphoedema-specific Patient Reported Outcome Measures using LYMPROM©
timeFrame: 0 days, 12 weeks
Secondary outcomes:
measure: The feasibility of recruiting 40 participants over 18 months to a study using IPC at home using screening and recruitment logs
timeFrame: 0 days, 18 months
measure: The acceptability of using Intermittent Pneumatic Compression (IPC) at home for 12-weeks including self-reported use (frequency and dose) of IPC using participant completed diaries
timeFrame: 0 days, 12 weeks
measure: Changes in contacts with health and social care services before and after the study using the Use of health and social-service questionnaire Client Service Receipt Inventory (CSRI)
timeFrame: 0 days, 12 weeks
measure: Changes in recourse use within health and social care services before and after the study using the Use of health and social-service questionnaire Client Service Receipt Inventory (CSRI)
timeFrame: 0 days, 12 weeks
measure: Changes in number of cellulitis episodes, hospital admissions (including length of stay), antibiotic use and number of days off work due to cellulitis as reported using the study case report form
timeFrame: 0 days, 12 weeks
measure: Changes in range of movement measures using the study case report form
timeFrame: 0 days, 12 weeks
measure: Changes in skin condition before and after the study including assessments of skin appearance (soft, fibrosis, discoloured) and the presence / absence of ulcers / wounds, Stemmer's signs and pitting oedema using the study case report form
timeFrame: 0 days, 12 weeks
measure: Changes in excess limb volumes using LymcalcTM, which uses the cylindrical calculation for limb volume
timeFrame: 0 days, 12 weeks
measure: Changes in lymphoedema staging / severity using the International Society of Lymphology (ISL) Staging of Lymphoedema
timeFrame: 0 days, 12 weeks
measure: Changes in lymphoedema staging / severity using the British Lymphology Society (BLS) Grouping of Lymphoedema
timeFrame: 0 days, 12 weeks
measure: Changes in lymphoedema staging / severity using the Lymphoedema Wales Clinical Network (LWCN) Lymphoedema Severity Outcomes of Lymphoedema
timeFrame: 0 days, 12 weeks
measure: Changes in health-related quality of life using the EQ-5D-5L
timeFrame: 0 days, 12 weeks
measure: Changes in work and activity as reported using the Work Productivity and Activity Impairment Questionnaire: Lymphoedema (WPAI-Lymphoedema)
timeFrame: 0 days, 12 weeks
measure: Procurement and life-time costs of home use compared with clinic based treatment
timeFrame: 0 days, 12 weeks
measure: Number of participants with treatment-related adverse events and their severity and relationship to the study as assessed by Participant Adverse Event Log
timeFrame: 0 days, 12 weeks
measure: Attrition will be reported in terms of number of participants recorded as loss to follow up as captured in the case report forms and study flow diagram.
timeFrame: 0 days, 18 months
Other outcomes:
measure: Patient experience
timeFrame: 12 weeks
Locations:
city: Swansea
country: United Kingdom
facility: Swansea Bay University Health Board
Study officials:
affiliation: Lymphoedema Wales
name: Marie Gabe-Walters, PhD
role: PRINCIPAL_INVESTIGATOR
References: