Boosted Compression for Lower Limb Chronic Edema

Change in edema volume will be evaluated using circumferential measurements. Circumferences of both legs will be measured at 4-cm intervals. Limb volumes will be calculated from the circumference measurements, and changes in edema volume will be assessed.

The pitting status is assessed by putting pressure on the edematous area; when the pressure is released, a visual or palpable indentation needs to be present for a +pitting, otherwise it is -pitting.

The local tissue water is assessed at each study time point: baseline, at the end of the intensive treatment phase, and at 1, 6, and 12 months during the maintenance phase. Local tissue water will be measured using a lymphscanner or moisture meter. Tissue Direct Current will be used to assess the amount of water 2,5 mm underneath the skin at predetermined locations on both legs.

Participants score cost-effectivess in terms of direct and indirect costs. The questionnaires are intended to provide an overview of the patient's background, household, and housing situation on the one hand, and the patient's health and work during the past four weeks on the other.

The purpose of the ICC compression questionnaire is to evaluate the effect of different kinds of compression materials and systems and its acceptance and experience by the patient. The compression questionnaire can be used for longitudinal comparative studies.

ICC patients is a questionnaire filled out by the patients assessing the use and comfort of compression bandages and/or garments.

The score on each domain ranges between 0 (worst fysical functioning/ fewest disease-related symptoms) and 10 (best fysical functioning/ most severe disease-related symptoms).

ICC PT is a questionnaire filled out by a therapist concerning the use of compression and describes the patient and the compression device/system.

In addition, the therapist performs an evaluation of the covering of the limb by the compression on the one hand and an evaluation of the skin under the compression on the other hand.

Some patient CFIR-informed interview domains by the study coordinator:

Focus areas: experience with assigned compression approach, perceived benefits and challenges, daily life integration and adherence, comparison with previous treatments, healthcare system interactions, support from family/social networks.

Some provider CFIR-informed interview by the study coordinator domains:

Focus areas: experience delivering interventions, perceived patient responses (Mechanisms + Individual Characteristics), implementation challenges and facilitators, training and support needs, professional networks and communication, organizational support and resources

The Dutch Lymph-ICF-LL is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life. Each question has to be scored on an 11-point scale (0 to 10). The anchor points for the physical and mental function domain and tasks/ household domain are 'not at all' and 'a lot'. Those for the mobility and life domain/ social life domain were 'very well' and 'not at all'. The total score on the LYMPH-ICF-LL is equal to the sum of the item scores divided by the total number of answered items. A higher score indicates a greater impact on the functioning in daily life related to lower limb lymphedema.

The EQ-5D-5L and EQ VAS are used to calculate Quality-Adjusted Life Years (QALYs) based on the Belgian value set, enabling comparison of the intervention with other healthcare investments. Results can also be compared with edema- and compression-specific quality-of-life questionnaires.

The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from no problems to extreme problems.

The EQ VAS measures the patient's self-rated health on a visual analogue scale ranging from "the worst health you can imagine" to "the best health you can imagine," providing a quantitative measure of perceived health

The Health Monitor is a concise and accessible questionnaire. It was developed because everyone experiences health differently. The better your personal health experience is known, the more targeted the care team can be in supporting you. In addition to medical treatment, we believe it is important to tailor additional support to your individual situation. We use the Health Monitor for this purpose.

The Health Monitor consists of two steps:

• Assessing your mental and physical health over the past four weeks.
• Determining (if necessary) how we can improve your perception of health.

Six items, scored on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), are used to assess perceived control (items 1, 3, and 5) and acceptance (items 2, 4, and 6). Scores for each domain are summed and divided by three. Based on a cut-off value of 5.0, patients are subsequently classified into a corresponding segment.

The general Self-efficacy Scale is a 10-item unidimensional questionnaire that assesses an individual's general confidence in their ability to cope with challenging or stressful situations. Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.

The IPAQ-SF is a 7-item self-report questionnaire that assesses open-ended questions surrounding individuals' last 7-day recall of physical activity.

Higher values indicate higher levels of physical activity.

The patient will complete a diary during the intensive and maintenance phase and return it at each measurement appointment. The diary will record adherence to the use of the compression bandage and garment, the content of physiotherapy sessions, and the follow-up of skincare, with a focus on reporting early adverse events.