Leg Ulcers Clinical Trial
Official title:
Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance With Compression Therapy and Prescribed Exercise in Leg Ulcer Patients
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.
The purpose of the study is testing 'Lively Legs' a compliance promotion program for
patients with leg ulcers. The study tests the program on effects regarding:
- compliance with compression therapy and exercise levels
- time to leg ulcer recurrence
- cost effectiveness from a social perspective.
The project is a multi centre study, using a randomized controlled design. Patients in the
study (n=380) are equally randomized to either the experimental or the control group.
Patients in the intervention group receive counseling 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.
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.
Individual counseling 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 counselor. In a maximum
of six consultations, they will offer tailored counseling, including compliance and physical
activity assessment, identification of relevant determinants of behavior, goal setting, and
the application of methods and strategies from the Lively Legs program
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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