LymphAssistTM at home
Research type
Research Study
Full 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)
IRAS ID
311663
Contact name
Marie Gabe-Walters
Contact email
Sponsor organisation
Swansea Bay University Health Board
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Summary of Research
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, movement / exercise, compression and massage / light touch). Intensive clinic-based treatments are available alongside usual care. For example, a type of air Pump which automatically inflates and deflates a special garment that is worn over the swollen area helps move the lymph (fluid associated with the swelling) to offer comfort and reduce pain.
However, Lymphoedema Services in Wales only offer using the Pump 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 Pump
This study will recruit 40 patients with lymphoedema to use the Pump daily at home for 12-weeks alongside their usual care. Participants will volunteer to take part through their Lymphoedema Service. Written consent will be required; however, participants can change their mind and this will not affect their care.
Information will be collected before and after the study including clinical measures (swelling, skin problems), patient outcomes (symptoms, quality of life) and experience. The study will compare the costs of buying the Pump 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 the Pump during an interview.
Findings will be shared by publication and presentation. If the benefits are shown, lymphoedema services might be able to provide the Pump for routine use at home through Value-Based procurement.Summary of Results
The summary with graphs will be available on the LWCN website during 2026: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Flwcn.nhs.wales%252F%2FNBTI%2FtQXDAQ%2FAQ%2F989597b2-bb40-42d9-88ae-9d9fe02b7542%2F1%2FbchL31hFIU&data=05%7C02%7Cwales.rec2%40wales.nhs.uk%7Caebe861afb1845b441de08de5f4def62%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C639052985487225706%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=mOtwYCEH9quuRLdHZXcVU3%2FmsrxDh%2FKhKbklxpx%2FHRQ%3D&reserved=0
Background
Lymphoedema is a chronic condition that causes long-term swelling. Usually this affects the legs but can also happen elsewhere in the body. Advanced intermittent pneumatic compression (IPC) is a type of intensive treatment used alongside usual care (like skin care, massage, movement, weight management and compression). IPC is often used to help reduce limb volumes and improve health-related quality of life. LymphAsssitTM is the name of the IPC used in Wales. Before funding could be considered for home-based IPC, this study examined the value of home-based IPC.What methods did we use?
Forty adults with arm or leg lymphoedema across Wales were invited to use IPC at home every day for 12-weeks. Each IPC session was 45-minute.
Study information collected before and after the 12-weeks included:
* Benefits to patients (e.g. health-related quality of life, limb volume, experiences)
* Costs (comparing costs for home and clinic use of IPC)
* Self-reported health and social care use (e.g. seeing GP for cellulitis).
Participants kept a diary about using IPC and wearing of their compression garments. At the end, participants were invited to talk about their experiences in an interview.Who took part in the study?
Forty participants were recruited May 2022 to September 2023. Average age was 62 years, 83% were female (33/40). Over half (25/40, 63%) used IPC on their arms. One person withdrew from the study as they felt their swelling was already well controlled. 13 participants took part in an interview.How often did the participants use IPC?
Based on the 37 participants who completed their diary, IPC was used:
* Between 42-84 days (maximum days over the 12 weeks was 84 days)
* Some used IPC more than once daily with an average of 92 IPC sessions over the 84 days (range 43-272). This means some participants added on extra sessions (and our interview data suggests this often happened in the evening).
Participants wore their usual compression garment for an average of 70 days over the 12-weeks (range 41-84) adding up to 919 hours (average 11 hours daily wear).What happened to the patient reported outcomes after IPC?
Patient reported outcomes significantly improved with the average LYMPROM© scores (out of 100) reducing from 45 to 39 (n=39). A lower LYMPROM© score means less reported impact of lymphoedema. A significant result suggests this result is likely to be explained by participants using IPC in the study, rather than by chance. Changes in EQ5D-5L scores were small and not significant. A non-significant result means the results may be explained by chance. The average health score out of 100 (where 100 is best health) was 72 before IPC and 70 after.What happened to limb volume after IPC?
There was a small non-significant reduction in limb volume after IPC.What about the costs after IPC?
Total reported health and social care costs reduced at the end of the study but not significantly. This may be due to low number or lots of variability in the costs reported by each of the participants. Overall, there was an average cost reduction of £1,497 per person. The cost of offering IPC at home for 12-weeks was £8,480 (based on a band 4 lymphoedema specialist providing an initial demonstration and taking an average 10-year lifetime IPC use). Offering a clinic equivalent (daily sessions for 12-weeks) would exceed £113,000.What were the experiences of participants using IPC at home?
Participant experiences were positive. Participants said IPC at home:
* Gave them more choice and involvement in their treatment
* Helped them manage their lymphoedema
* Was relaxing and convenient
* Fitted well into daily life. Some participants chose to take their IPC on their travels (holiday or for work) whilst others preferred to take short breaks away.
* Reduced the need to travel to clinic or take time off work
Most found IPC easy to use and keeping the device set-up ready in one room helped, however there were some challenges:
* Finding space to store the device
* Needing help from family or carers to put on or take of the attachments
Participants talked about why they wanted to try IPC at home in this study and many said it was a chance to trying something to help manage their lymphoedema or to get the best outcome for them. Some said it was a chance to 'try before you buy'. A few participants reported having a positive experience of clinic-based IPC and so wanted to try it a home. Interestingly, some participants had not heard of IPC before the study.
Taking stock, participants felt there was an overall benefit to using IPC even if this wasn't always shown in their volume measurements. For example, one participant said: "...I was hoping that the results would be good. They weren't brilliant to be honest, but in lots of ways that didn't matter because it made me feel good and I could I could feel the difference in my legs... I mean if you have got the choice between a fat leg that's heavier or a fat leg that feels light, you're going to go for the light one."Were there any issues?
There were no direct issues with using IPC. Four participants developed cellulitis (a skin infection), which is commonly seen in patients with lymphoedema. Participants took a break from IPC until they felt well enough. Two other participants reported short-lived changes in sensation, which were resolved by using the IPC in a more relaxed position. One participant reported a fall (unrelated to the study).So, what were the top three findings?
1. Patient reported outcomes were significantly better after using IPC.
2. Limb volumes did not significantly change, however, some felt that volume measurements were not always the most important thing to them.
3. There were some reductions in the reported health and social care costs after IPC use, but these were not significant.
Overall, there is a value to home-based IPC, but these results should be considered carefully in this small study that was the first of its kind. Using a real-world design however, will help to think about the possible impact if adopted into usual care.How can we understand more about the results?
There are some important considerations when thinking about the results:
* The EQ5D-5L may not be sensitive enough to detect changes for people living with lymphoedema.
* Limb volumes did not significantly reduce after IPC use, but this might be due to changes in the structure of the tissues (e.g., softening fibrotic tissues) or because of a range of reported IPC use.
* This study could not verify all self-reported health or social care costs and some of the cost reductions will represent a cost avoidance (that allows other NHS services to focus care) rather than saving.
* Home-use of IPC also offers the chance to free up clinical space to focus on other intensive treatments, which may be an additional benefit to the wider lymphoedema service.Next steps
In response to this study, Lymphoedema Wales has:
* Shared the IPC devices used in this study with lymphoedema services across Wales to offer home-based IPC for patients within routine care. Note, this offers a limited number of additional IPC devices to Health Boards.
* Explored funding options to look at the education needs of lymphoedema therapists providing IPC to help us understand more about routine use of IPC.
* To provide equitable access to this value-based initiative across Wales, funding options will be considered in more details.How will Lymphoedema Wales Clinical Network share the results of this study?
Interim or early findings were presented at national and international conferences to academics, therapists, and patients. The results will be published in a peer-reviewed health journal. This will be like this summary but will include more of the numbers / statistics from the study. These results will also be shared at conference and locally with lymphoedema services and our patient advisory panel. The summary report will be shared with all study participants and be made available to service users.REC name
Wales REC 2
REC reference
22/WA/0068
Date of REC Opinion
15 Mar 2022
REC opinion
Favourable Opinion