LymphAssistTM at Home (LAAH)

NCT05456568 | Completed

• 1 other identifier: LymphAssist at home Protocol
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema Arm; Lymphedema of Leg

Outcome Measures

Primary Outcomes (1)

• Changes in Lymphoedema-specific Patient Reported Outcome Measures using LYMPROM©

  The effect Intermittent Pneumatic Compression (IPC) has on Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM©) scores. LYMPROM© is a lymphoedema specific PROM that captures 13 outcomes covering physical, social and emotional health domains. LYMPROM© version 1.2 (26/03/2021) uses a scale where patients can report each item using a 0-10 score, where zero represents no impact and 10 represents extreme impact. A higher score reflects a worse outcome. Four of the items also include a 'not applicable response' option. At the end of LYMPROM© there is a free text box for patients to report descriptively on any other impact.

  0 days, 12 weeks

Secondary Outcomes (16)

• The feasibility of recruiting 40 participants over 18 months to a study using IPC at home using screening and recruitment logs

  0 days, 18 months

• 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

  0 days, 12 weeks

• 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)

  0 days, 12 weeks

• 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)

  0 days, 12 weeks

• 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

  0 days, 12 weeks

Other Outcomes (1)

• Patient experience

  12 weeks

Study Arms (1)

All participants

EXPERIMENTAL

All participants will use IPC daily at home for 12 weeks alongside usual and standard care

Device: LymphAssistTM Professional

Interventions

LymphAssistTM Professional DEVICE

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

Also known as: Hydroven 12

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swansea Bay University Health Board: lead
• Lymphoedema Wales Clinical Network: collaborator
• Swansea University: collaborator
• Huntleigh Healthcare Ltd: collaborator

Study Sites (1)

Swansea Bay University Health Board

Swansea, SA2 8PP, United Kingdom

Location

Study Officials

• Marie Gabe-Walters, PhD

  Lymphoedema Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 13, 2022
• Study Start: July 6, 2022
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)