Boosted Compression for Lower Limb Chronic Edema

Primary

The first objective of this project is to demonstrate the possibility to reduce the duration of the intensive treatment phase when the boosted compression therapy is used compared to standard care of 1 application. Therefore, the primary objective is to evaluate the efficacy of boosted compression bandaging (3 applications/day applied by the patient, physiotherapist, home nurse, partner, family member…) administered during the intensive treatment phase of treatment for lower limb chronic edema in real-world clinical settings, relative to the current standard care (1 applications/day applied by the physiotherapist).

However, an effective treatment of chronic edema can only be achieved when the reduction in edema volume is maintained after the intensive treatment phase. As such, the investigators also need to demonstrate that during follow-up, which is called the maintenance phase, the edema reduction is maintained in the same way or even better in comparison to the current standard maintenance phase. Therefore, in the second objective, the investigators will assess whether in the long term the edema reduction is maintained in the same way between standard CDT and after boosted compression (non-inferiority statement).

The primary outcome measure is the number of days to obtain non-pitting state during intensive phase, edema volume (with circumferences measurements) and water content in tissue (with tissue dielectric constant) at the start and end of the intensive phase and after 4 months, 6 months and 1 year of follow-up in the maintenance phase.

Secondary

Treatment effectiveness requires patient adherence and acceptability. Clinical experience reveals multiple implementation barriers to compression bandaging: physical discomfort (tightness, heat, bulk affecting clothing/footwear), procedural burden (time-intensive application), financial barriers (non-reimbursed costs, need for multiple sets), and social acceptability concerns (cosmetic appearance limiting public/social use). These barriers collectively reduce real-world treatment fidelity. A first secondary objective examines whether a time-limited boosted compression protocol is acceptable and people adherence to it.

Optimization of the intensive phase has the potential to improve cost-effectiveness. Boosted compression bandaging therapy is likely to reduce the treatment days, and potentially even so treatment hours, which have implications for direct and indirect costs. In the end, also the effect on Quality of Life (QoL) should be considered and each treatment arm translated in quality-adjusted life years (QALY) gained. Data on costs and effects measured for each trial-participant will allow to perform a trial-based economic evaluation. The physical therapy related standard tariffs and treatment protocol will serve as the starting point. In addition, therapy-related additional costs and overall time spend on treatment will be collected. The primary outcome of interest is the incremental cost-effectiveness ratio (ICER), which is calculated by dividing the difference in mean costs between study groups by the difference in health-related effects. If there are negative costs (i.e. savings) and/or health effects, the net monetary benefit approach will be adopted to evaluate the cost-effectiveness of the intervention. The proposed health economic evaluation is informative from the public healthcare payer and societal perspective by including both the direct and indirect, medical and non-medical costs. As such, in the second secondary objective, the investigators will study the cost-effectiveness of boosted compression bandaging therapy in comparison with the current standard care of CDT.

The third secondary objective includes considering the baseline characteristics and the follow-up results will allow to define predictive factors for the success or failure of this treatment in the intensive treatment phase and 1 year of follow-up in the maintenance phase. This will allow to create a risk assessment for patients starting a new treatment for chronic edema.

• Cost-effectiveness assessment with an adapted iMTA medical constumption questionnaire and IMTA Productivity cost questionnaire [Срок оценки: Assessed at the end of the intensive treatment phase/ at 6 months after the end of intensive treatment phase (maintenance phase).]
• Effect of compression and acceptance by patient (Dutch ICC-compression questionnaire) [Срок оценки: Patients: Baseline/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/study completion at 12 months Therapist: baseline/end of intervention phase]
• Acceptance and adherence (qualitative research by interviews) [Срок оценки: End intensive treatment phase until data saturation]
• Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema [Срок оценки: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).]
• Health-related quality of Life (EQ 5D-5L) (Belgian) [Срок оценки: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).]
• Health monitor [Срок оценки: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).]
• General self-efficacy scale [Срок оценки: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).]
• International Physical Activity Questionnaire-Short Form [Срок оценки: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).]
• Diary [Срок оценки: During the intensive treatment phase and the maintenance phase until study completion of 1 year after the end of the intervention or intensive treatment phase.]