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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

September 12, 2005
February 8, 2010
January 2005
May 2008   (final data collection date for primary outcome measure)
  • * 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 ]
  • * Compliance with compression therapy
  • * Compliance with exercise presriptions
  • * Leg ulcer recurrence
  • PRIMARY
Complete list of historical versions of study NCT00184873 on ClinicalTrials.gov Archive Site
  • * 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 ]
  • * time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods
  • * evaluation of the cost effectiveness of the program
Not Provided
Not Provided
 
Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients
Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance With Compression Therapy and Prescribed Exercise in Leg Ulcer Patients

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Leg Ulcers
  • Varicose Ulcers
Behavioral: Health Counseling
  • Active Comparator: Lifestyle counseling
    Patients receiving lifestyle counseling
    Intervention: Behavioral: Health Counseling
  • No Intervention: Regular care
    Patients receiving regular care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00184873
13091966, ZonMw 945-04-058
No
Prof. T. van Achterberg, IQ healthcare, Scientific Institute for Quality of Healthcare
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Study Director: Theo van Achterberg, RN, PhD IQ healthcare, Scientific Institute for Quality of healthcare, Radboud University Medical Centre, Nijmegen, The Netherlands
Radboud University
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP