Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients

Not Applicable

Completed

• Conditions: Leg Ulcers; Varicose Ulcers
• Interventions: Behavioral: Health Counseling

• Registration Number: NCT00184873
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2007-08
• Primary Completion: 2008-05
• Study Completion: 2008-12
• Last Update Submitted: 2010-02-08
• Last Update Posted: 2010-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Venous insufficiency
• Venous and arterial insufficiency
• Receiving treatment on outpatient clinics for dermatology at the moment of inclusion or in the past three months before inclusion

Read More

Exclusion Criteria

• Total immobility
• Insufficient mental capacity
• Insufficient comprehension of the dutch language

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Health Counseling	Patients receiving lifestyle counseling

Primary Outcome Measures

Name	Time	Method
* Compliance with compression therapy	18 months
* Compliance with exercise prescriptions	18 months
* Leg ulcer recurrence	18 months

Secondary Outcome Measures

Name	Time	Method
* time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods	18 months
* evaluation of the cost effectiveness of the program	18 months

Trial Locations

Locations (11)

Jeroen Bosch ziekenhuis; 🇳🇱 Den Bosch, Noord Brabant, Netherlands

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands

Vie Curi; 🇳🇱 Venlo / Venray, Limburg, Netherlands

Elkerliek ziekenhuis; 🇳🇱 Deurne, Noord Brabant, Netherlands

St Anna ziekenhuis; 🇳🇱 Geldrop, Noord Brabant, Netherlands

ErasmusMC; 🇳🇱 Rotterdam, Zuide Holland, Netherlands

Bernhoven ziekenhuis; 🇳🇱 Veghel, Noord Brabant, Netherlands

Ziekenhuis Rivierenland; 🇳🇱 Tiel, Gelderland, Netherlands

IJssellandziekenhuis; 🇳🇱 Capelle A/d IJssel, Zuid Holland, Netherlands

Slingeland ziekenhuis; 🇳🇱 Doetinchem, Gelderland, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands