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Sponsors and Collaborators: |
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00184873 |
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:
Condition | Intervention |
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Leg Ulcers Varicose Ulcers |
Behavioral: Health Counseling |
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 |
Estimated Enrollment: | 380 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | July 2007 |
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
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maud Heinen, MSc | +31243619326 | m.heinen@kwazo.umcn.nl |
Contact: Theo Achterberg van, PhD | +3124369529 | t.vanachterberg@kwazo.umcn.nl |
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 |
Study Director: | Theo van Achterberg, RN, PhD | Center of quality of care research, Radboud University Nijmegen Medical Center |
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) |
randomized controlled trial health-counseling multi-center study |
Varicose Ulcer Varicose Veins Skin Diseases Ulcer |
Vascular Diseases Skin Ulcer Leg Ulcer |
Pathologic Processes Cardiovascular Diseases |