Clinical trial NCT00184873: Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients
Official title: Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance With Compression Therapy and Prescribed Exercise in Leg Ulcer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcers
Varicose Ulcers
Keywords: randomized controlled trial
health-counseling
multi-center study
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-09-16
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: * Compliance with compression therapy
timeFrame: 18 months
measure: * Compliance with exercise prescriptions
timeFrame: 18 months
measure: * Leg ulcer recurrence
timeFrame: 18 months
Secondary outcomes:
measure: * time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods
timeFrame: 18 months
measure: * evaluation of the cost effectiveness of the program
timeFrame: 18 months
Other outcomes:
Locations:
city: Doetinchem
country: Netherlands
facility: Slingeland ziekenhuis
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
city: Tiel
country: Netherlands
facility: Ziekenhuis Rivierenland
state: Gelderland
city: Venlo / Venray
country: Netherlands
facility: Vie Curi
state: Limburg
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch ziekenhuis
state: Noord Brabant
city: Deurne
country: Netherlands
facility: Elkerliek ziekenhuis
state: Noord Brabant
city: Geldrop
country: Netherlands
facility: St Anna ziekenhuis
state: Noord Brabant
city: Veghel
country: Netherlands
facility: Bernhoven ziekenhuis
state: Noord Brabant
city: Capelle A/d IJssel
country: Netherlands
facility: IJssellandziekenhuis
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: ErasmusMC
state: Zuide Holland
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: IQ healthcare, Scientific Institute for Quality of healthcare, Radboud University Medical Centre, Nijmegen, The Netherlands
name: Theo van Achterberg, RN, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.