Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients
NCT ID: NCT00184873
Last Updated: 2010-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2005-01-31
2008-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Lifestyle counseling
Patients receiving lifestyle counseling
Health Counseling
Regular care
Patients receiving regular care
No interventions assigned to this group
Interventions
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Health Counseling
Eligibility Criteria
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Inclusion Criteria
* 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
* Insufficient mental capacity
* Insufficient comprehension of the dutch language
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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IQ healthcare, Scientific Institute for Quality of Healthcare
Principal Investigators
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Theo van Achterberg, RN, PhD
Role: STUDY_DIRECTOR
IQ healthcare, Scientific Institute for Quality of healthcare, Radboud University Medical Centre, Nijmegen, The Netherlands
Locations
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Slingeland ziekenhuis
Doetinchem, Gelderland, Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands
Ziekenhuis Rivierenland
Tiel, Gelderland, Netherlands
Vie Curi
Venlo / Venray, Limburg, Netherlands
Jeroen Bosch ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
Elkerliek ziekenhuis
Deurne, North Brabant, Netherlands
St Anna ziekenhuis
Geldrop, North Brabant, Netherlands
Bernhoven ziekenhuis
Veghel, North Brabant, Netherlands
IJssellandziekenhuis
Capelle aan den IJssel, South Holland, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
ErasmusMC
Rotterdam, Zuide Holland, Netherlands
Countries
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References
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Heinen MM, van Achterberg T, op Reimer WS, van de Kerkhof PC, de Laat E. Venous leg ulcer patients: a review of the literature on lifestyle and pain-related interventions. J Clin Nurs. 2004 Mar;13(3):355-66. doi: 10.1046/j.1365-2702.2003.00887.x.
Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof PC, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs. 2004 Mar;13(3):341-54. doi: 10.1046/j.1365-2702.2003.00859.x.
Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ Behav. 1998 Oct;25(5):545-63. doi: 10.1177/109019819802500502.
Harper PL, Watson L, Bannon R. Compression ultrasonography for diagnosing deep vein thrombosis. Protocol is safe. BMJ. 1998 May 16;316(7143):1534; author reply 1535. No abstract available.
Kan YM, Delis KT. Hemodynamic effects of supervised calf muscle exercise in patients with venous leg ulceration: a prospective controlled study. Arch Surg. 2001 Dec;136(12):1364-9. doi: 10.1001/archsurg.136.12.1364.
Nelson EA, Bell-Syer SE, Cullum NA. Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev. 2000;(4):CD002303. doi: 10.1002/14651858.CD002303.
Yang D, Vandongen YK, Stacey MC. Effect of exercise on calf muscle pump function in patients with chronic venous disease. Br J Surg. 1999 Mar;86(3):338-41. doi: 10.1046/j.1365-2168.1999.00993.x.
Other Identifiers
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ZonMw 945-04-058
Identifier Type: -
Identifier Source: secondary_id
13091966
Identifier Type: -
Identifier Source: org_study_id
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