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Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients
This study is currently recruiting participants.
Verified by Radboud University, February 2006
Sponsors and Collaborators: Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00184873
  Purpose

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.

Condition Intervention
Leg Ulcers
Varicose Ulcers
Behavioral: Health Counseling

MedlinePlus related topics: Exercise and Physical Fitness Leg Injuries and Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance With Compression Therapy and Prescribed Exercise in Leg Ulcer

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • PRIMARY
  • * Compliance with compression therapy
  • * Compliance with exercise presriptions
  • * Leg ulcer recurrence

Secondary Outcome Measures:
  • * time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods
  • * evaluation of the cost effectiveness of the program

Estimated Enrollment: 380
Study Start Date: January 2005
Estimated Study Completion Date: July 2007
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Total immobility
  • Insufficient mental capacity
  • Insufficient comprehension of the dutch language
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184873

Contacts
Contact: Maud Heinen, MSc +31243619326 m.heinen@kwazo.umcn.nl
Contact: Theo Achterberg van, PhD +3124369529 t.vanachterberg@kwazo.umcn.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Antoinette Scheerhoorn, Ba         a.scheerhoorn@umcu.nl    
Sub-Investigator: Carin Smit, RN            
Netherlands, Gelderland
Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Peter van de Kerkhof, MD / PhD         p.vandekerkhof@derma.umcn.nl    
Sub-Investigator: Jolanda Zonnenberg, RN            
Slingeland ziekenhuis Recruiting
Doetinchem, Gelderland, Netherlands, 7009BL
Contact: Dr. Sybrandy, PhD         secretariaat.dermatologie@slingeland.nl    
Sub-Investigator: Margre Wentink            
Ziekenhuis Rivierenland Recruiting
Tiel, Gelderland, Netherlands, 4002 WP
Contact: Willy Rijnten, MD         w.rijnten@zrt.nl    
Sub-Investigator: Mieke Walg            
Netherlands, Limburg
Vie Curi Recruiting
Venlo / Venray, Limburg, Netherlands, 5900 BX
Contact: Michette de Rooij, MD, PhD         mderooij@viecuri.nl    
Sub-Investigator: Carla Rippens            
Netherlands, Noord Brabant
Jeroen Bosch ziekenhuis Recruiting
Den Bosch, Noord Brabant, Netherlands, 5323 GV
Contact: Henk Rijken, BA         h.rijken@jbz.nl    
Sub-Investigator: Mery Jansen            
St Anna ziekenhuis Recruiting
Geldrop, Noord Brabant, Netherlands, 5664EH
Contact: Roland Mommers, MD, PhD         r.mommers@st-anna.nl    
Sub-Investigator: Marleen van Diessen            
Elkerliek ziekenhuis Recruiting
Deurne, Noord Brabant, Netherlands, 5751 CB
Contact: Fransje Castelijns, MD         fcastelijns@elkerliek.nl    
Sub-Investigator: Jose van den Westen            
Bernhoven ziekenhuis Recruiting
Veghel, Noord Brabant, Netherlands, 5461 AA
Contact: Kees Peter de Roos, MD. PhD         k.deroos@bernhoven.nl    
Sub-Investigator: Sevgi Mulazim            
Netherlands, Zuid Holland
IJssellandziekenhuis Recruiting
Capelle aan de IJssel, Zuid Holland, Netherlands, 2906 ZC
Contact: Karin Timm, RN         Ktimm@ysl.nl    
St Franciscus gasthuis Recruiting
Rotterdam, Zuid Holland, Netherlands, 3045 PM
Contact: Miriam Loots, MD         m.loots@sfg.nl    
Sub-Investigator: Saskia Klein, RN            
Netherlands, Zuide Holland
ErasmusMC Recruiting
Rotterdam, Zuide Holland, Netherlands, 3015 GJ
Contact: Kai Munte, MD, PhD         k.munte@erasmusmc.nl    
Sub-Investigator: Karin van Gemeren, RN            
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Theo van Achterberg, RN, PhD Center of quality of care research, Radboud University Nijmegen Medical Center
  More Information

Publications:
Study ID Numbers: 13091966, ZonMw 945-04-058
Study First Received: September 12, 2005
Last Updated: February 1, 2006
ClinicalTrials.gov Identifier: NCT00184873  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
randomized controlled trial
health-counseling
multi-center study

Study placed in the following topic categories:
Varicose Ulcer
Varicose Veins
Skin Diseases
Ulcer
Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009