LEG TEST. Multi centre testing of the Lively Legs program for promoting compliance with compression therapy and prescribed exercise in leg ulcer patients
Projectomschrijving
Ulcus cruris, ook wel 'open been' genoemd is een vaak chronische complicatie van een slechte doorbloeding. Het is bekend dat de leefstijl van patiënten van invloed is op het ontstaan ervan. Vooral beweging, beenoefeningen, en therapietrouw met betrekking tot compressietherapie (steunkousen of zwachtels) zijn belangrijk in het voorkomen van herhaalde wonden. Uit onderzoek blijkt dat veel patiënten juist weinig bewegen en dat zwachtels of therapeutisch elastische kousen niet altijd volgens voorschrift worden gedragen. Daar komt bij dat hulpverleners vaak te weinig aandacht hebben voor deze ‘therapieontrouw’. Prof. dr. T. van Achterberg (UMC St Radboud) testte in dit project het Lively Legs leefstijlprogramma. Dit programma is gericht op het vergroten van therapietrouw met compressietherapie en bewegingsadviezen. Het programma blijkt een positief effect te hebben op de therapietrouw met betrekking tot compressie en beweging. Ook was de wondvrije tijd na wondgenezing langer. Mede hierdoor ervaren de patiënten hun kwaliteit van leven significant beter.
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Samenvatting van de aanvraag
BACKGROUND - Leg ulcers are often chronic or recurring complications of peripheral circulation disorders. Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in general. Especially exercise and compliance with compression therapy are key elements in the course of leg ulcer healing and recurrence. Yet many patients demonstrate sedentary lifestyles and non-compliance and current practice offers no systematic approach in the promotion of compliance and physical activity in these patients. OBJECTIVE - The project LEG TEST aims at testing 'Lively Legs' a compliance promotion program for patients with leg ulcers. The study tests the program on effects regarding: 1) compliance with compression therapy and exercise levels; 2) time to leg ulcer recurrence; 3) cost effectiveness from a social perspective. STUDY DESIGN - The project is a multi centre study, using a randomized controlled design. Patients in the study (n=380) are equally randomised to either the experimental or the control group. Patients in the intervention group receive counselling during a period of six months, in line with the Lively Legs program. Patients in the control group receive regular care. Recruitment takes place within a period of nine months. Data are collected at baseline, directly after the intervention period at 6 months, and at follow-ups at 12 and 18 months. Quality of life is additionally assessed at 3, 9 and 15 months. STUDY POPULATION - The population for this study consists of leg ulcer patients, suffering from peripheral circulation disorders of venous or mixed (venous and arterial) origin. The population is restricted to patients treated at outpatient clinics for dermatology. INTERVENTION - Individual counselling is performed by nurses, based on the Lively Legs lifestyle program for leg ulcer patients. This evidence based program was systematically developed using the Intervention Mapping framework, thus integrating scientific evidence, relevant theories and patient and care provider expertise. The program aims at improved compliance with compression therapy and prescribed exercise level in all patients. Social Cognitive Theory provides the theoretical framework and the core methods for the Lively Legs program. Nurses will perform the central role as health counsellor. In a maximum of six consultations, they will offer tailored counselling, including compliance and physical activity assessment, identification of relevant determinants of behaviour, goal setting, and the application of methods and strategies form the Lively Legs program. OUTCOME MEASURES - Compliance with compression therapy and prescribed exercise level and time to next ulcer are primary outcomes of the study. These primary outcomes will be evaluated using a combination of patient reported and more objective measures. Additionally, ulcer size and time to heal (in case of recurrence) will be evaluated. For the purpose of evaluating the cost effectiveness of the program, data on quality of life, number, duration and costs of patient-care provider contacts within the program and number, duration and costs of patient-care provider contacts outside the program will be collected. POWER & ANALYSES - The central analyses for this study are a Cox-regression for time to next ulcer and logistic regression for compliance with compression therapy and prescribed exercise. From our previous studies (Heinen et al. 2002) it can be estimated that in 50% of the patients in the control group, leg ulcers will have recurred at 18 months after inclusion. A reduction to 35% in the experimental group can be seen as relevant to clinical practice. Given a drop-out rate of 2% per month, 380 patients (2x190) should be included in this study (two-sided testing with alpha=.05 and power=.80). Compliance with compression therapy is estimated at 70%. The sample size of 380 allows for an increase to 85% in the intervention group to be identified as a significant effect of the intervention. The number of patients who currently comply with the prescribed exercise level is estimated at 40%. Our sample size is sufficient to demonstrate an increase to 55% in the intervention group. ECONOMIC EVALUATION - The economic evaluation studies whether the Lively Legs program is efficient when compared to usual care, adopting a societal perspective. The decision concerning whether or not the lifestyle intervention is efficient will be based on the incremental cost-effectiveness ratio 'costs per quality adjusted life year (QALY)'. TIME SCHEDULE months 1-3: study preparation months 4-12: inclusion and baseline data collection months 4-18: subsequent performance of the intervention months 10-30: follow-up data collection months 31-36: analyses and report