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

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ClinicalTrials.gov Identifier: NCT00184873
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 9, 2010
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Leg Ulcers Varicose Ulcers Behavioral: Health Counseling Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lifestyle counseling
Patients receiving lifestyle counseling
Behavioral: Health Counseling
No Intervention: Regular care
Patients receiving regular care



Primary Outcome Measures :
  1. * Compliance with compression therapy [ Time Frame: 18 months ]
  2. * Compliance with exercise prescriptions [ Time Frame: 18 months ]
  3. * Leg ulcer recurrence [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. * time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods [ Time Frame: 18 months ]
  2. * evaluation of the cost effectiveness of the program [ Time Frame: 18 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184873


Locations
Netherlands
Slingeland ziekenhuis
Doetinchem, Gelderland, Netherlands, 7009BL
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
Ziekenhuis Rivierenland
Tiel, Gelderland, Netherlands, 4002 WP
Vie Curi
Venlo / Venray, Limburg, Netherlands, 5900 BX
Jeroen Bosch ziekenhuis
Den Bosch, Noord Brabant, Netherlands, 5323 GV
Elkerliek ziekenhuis
Deurne, Noord Brabant, Netherlands, 5751 CB
St Anna ziekenhuis
Geldrop, Noord Brabant, Netherlands, 5664EH
Bernhoven ziekenhuis
Veghel, Noord Brabant, Netherlands, 5461 AA
IJssellandziekenhuis
Capelle A/d IJssel, Zuid Holland, Netherlands, 2906 ZC
ErasmusMC
Rotterdam, Zuide Holland, Netherlands, 3015 GJ
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Theo van Achterberg, RN, PhD IQ healthcare, Scientific Institute for Quality of healthcare, Radboud University Medical Centre, Nijmegen, The Netherlands

Publications:
Responsible Party: Prof. T. van Achterberg, IQ healthcare, Scientific Institute for Quality of Healthcare
ClinicalTrials.gov Identifier: NCT00184873     History of Changes
Other Study ID Numbers: 13091966
ZonMw 945-04-058
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: August 2007

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

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases