Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184873
Status:
COMPLETED
Last Update Posted:
2010-02-09
First Post:
2005-09-12
Brief Title:
Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance With Compression Therapy and Prescribed Exercise in Leg Ulcer Patients
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 n380 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZonMw 945-04-058 | None | None | None |