Investigating Value-Based Procurement and Patient Reported Outcomes From Adults With Lymphoedema Using a 12-week Home-based Programme of LymphAssistTM (Intermittent Pneumatic Compression)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Lymphoedema-specific Patient Reported Outcome Measures using LYMPROM©
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in Lymphoedema-specific Patient Reported Outcome Measures using LYMPROM©
时间窗: 0 days, 12 weeks
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.
次要结局
- 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)
- Changes in lymphoedema staging / severity using the British Lymphology Society (BLS) Grouping of Lymphoedema(0 days, 12 weeks)
- 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 lymphoedema staging / severity using the Lymphoedema Wales Clinical Network (LWCN) Lymphoedema Severity Outcomes of Lymphoedema(0 days, 12 weeks)
- Changes in work and activity as reported using the Work Productivity and Activity Impairment Questionnaire: Lymphoedema (WPAI-Lymphoedema)(0 days, 12 weeks)
- 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)
- 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 range of movement measures using the study case report form(0 days, 12 weeks)
- 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(0 days, 12 weeks)
- Changes in excess limb volumes using LymcalcTM, which uses the cylindrical calculation for limb volume(0 days, 12 weeks)
- Changes in lymphoedema staging / severity using the International Society of Lymphology (ISL) Staging of Lymphoedema(0 days, 12 weeks)
- Procurement and life-time costs of home use compared with clinic based treatment(0 days, 12 weeks)
- Changes in health-related quality of life using the EQ-5D-5L(0 days, 12 weeks)
- Number of participants with treatment-related adverse events and their severity and relationship to the study as assessed by Participant Adverse Event Log(0 days, 12 weeks)
- 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.(0 days, 18 months)