Patients: Patients targeted in this proposal comprise individuals afflicted by chronic edema/lymphedema of the lower limbs. Intervention: The intervention entails the incorporation of boosted compression alongside standard care during the intensive treatment phase. Boosted compression involves thrice-daily re-application of a multicomponent short stretch compression bandage, aimed at enhancing the efficacy of compression therapy within edema treatment. Comparison: Comparison will be made between the experimental intervention (boosted compression) and the prevailing standard edema treatment, which adheres to the complex decongestive therapy as stipulated by healthcare services, utilizing a single daily application of compression bandage. Standard care is administered under the supervision of trained physical therapists, specialized in edema treatment. Outcome: Primary outcomes encompass the determination of: 1. the requisite number of treatment days to attain a non-pitting edema state during the intensive phase of edema treatment; and 2. the non-inferiority of boosted compression in maintaining reduced edema volume during the maintenance phase assessed at 1y of follow-up. Secondary outcomes encompass assessments of: Quality of Life, acceptance, and adherence to boosted compression, alongside evaluations of time and cost-effectiveness associated with its implementation.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Conservative decongestive edema treatment with a single application of the compression bandage/day.
Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage)
Antwerp University Hospital
Edegem, Antwerp, Belgium
RECRUITINGUniversity of Antwerp
Wilrijk, Antwerp, Belgium
RECRUITINGUniversity Hospital Leuven
Leuven, Brabant, Belgium
RECRUITINGGhent University Hospital
Ghent, East Flanders, Belgium
RECRUITINGChange of edema volume during the intensive treatment phase and maintenance phase.
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.
Time frame: 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).
Number of days to obtain non-pitting state (with pitting test) during intensive phase
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.
Time frame: 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).
Change of water content in tissue (with TDC/PWC) during the intensive treatment phase and maintenance phase.
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.
Time frame: 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).
Cost-effectiveness assessment with an adapted iMTA medical constumption questionnaire and IMTA Productivity cost questionnaire
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.
Time frame: 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)
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.
Time frame: 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)
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
Time frame: End intensive treatment phase until data saturation
Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema
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.
Time frame: 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)
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
Time frame: 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
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: 1. Assessing your mental and physical health over the past four weeks. 2. 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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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.
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