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

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00184873
First received: September 12, 2005
Last updated: February 8, 2010
Last verified: August 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • * Compliance with compression therapy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • * Compliance with exercise prescriptions [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • * Leg ulcer recurrence [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • * time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • * evaluation of the cost effectiveness of the program [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lifestyle counseling
Patients receiving lifestyle counseling
Behavioral: Health Counseling
No Intervention: Regular care
Patients receiving regular care

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: September 12, 2005
Last Updated: February 8, 2010
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

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

ClinicalTrials.gov processed this record on October 19, 2014