Effectiveness of BoostEd COMpresson for the Treatment of Lower Limb Chronic Edema (BECOME): a Pragmatic Multi-centric Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change of edema volume during the intensive treatment phase and maintenance phase.
研究概览
简要总结
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:
- the requisite number of treatment days to attain a non-pitting edema state during the intensive phase of edema treatment; and
- 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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, blinding of the patients and most of the study team members is impossible. However, the assessors will be blinded to group allocation limiting the possibility to any assessment bias. To fulfill the prerequisite of blinded assessments participants will be instructed not to discuss any details of their treatment with the assessors.
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
- •Patients suffering from chronic edema ( > 3 months) of the lower extremity with a positive pitting sign and a conservative treatment is prescribed.
- •≥ 18 years old
- •BMI is <36
- •Able to understand and follow instructions in Dutch
排除标准
- •All treatable causes of chronic edema, such as hormonal disturbances (e.g. thyroid dysfunction), protein abnormalities (especially Albumin), cardiac insufficiency, nephrological conditions, drug-induced edema or peripheral arterial disease.
- •Peripheral arterial disease (ABI < 0.55)
- •The patient is allergic for one of the products we use during the treatment, and no alternative is available
- •The patient has wounds at the level of the treated edema zone.
- •The patient is currently receiving treatment within the convention "lymfoedeem" according to the Belgian Health insurance (RIZIV-INAMI).
- •The patient is not able to give written consent.
结局指标
主要结局
Change of edema volume during the intensive treatment phase and maintenance phase.
时间窗: 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 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.
Number of days to obtain non-pitting state (with pitting test) during intensive phase
时间窗: 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).
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.
Change of water content in tissue (with TDC/PWC) during the intensive treatment phase and maintenance phase.
时间窗: 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).
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.
次要结局
- Cost-effectiveness assessment with an adapted iMTA medical constumption questionnaire and IMTA Productivity cost questionnaire(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)(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)(End intensive treatment phase until data saturation)
- Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema(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)(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(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(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(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(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.)
研究者
Nick Gebruers
Associate Professor
Universiteit Antwerpen