NCT03454698: legulcer

Education for Venous Leg Ulcer Patients

Completed NA Last updated 4 April 2019

What this trial tests

NA trial testing Education in Interprofessional Education for Venous Leg Ulcer Patients in 13 participants. Completed in 31 December 2018.

Timeline

1 May 2018

Primary endpoint
31 October 2018

31 December 2018

Quick facts

Lead sponsor	School of Health Sciences Geneva
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	13
Start date	1 May 2018
Primary completion	31 October 2018
Estimated completion	31 December 2018
Sites	1 location across Switzerland

Drugs / interventions tested

• Education

Conditions studied

• Interprofessional Education for Venous Leg Ulcer Patients — all drugs for Interprofessional Education for Venous Leg Ulcer Patients →

Sponsor

School of Health Sciences Geneva

Who can join

18 and older, any sex, with Interprofessional Education for Venous Leg Ulcer Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Venous leg ulcers (VLU) are slow healing wounds. They have a high recurrence rate and are associated with pain, infection, smell and exudate. 60% of VLU become chronic. Current therapeutic approaches are multifaceted and focus on improving wound healing and preventing recurrences. As those approaches include compression therapy, leg elevation, specific exercises for the foot/ ankle region and a protein rich diet/ nutrition plan a multidisciplinary team of health care professionals such as nursing, physiotherapy, occupational therapy and nutrition specialists. Most persons with VLU have a knowledge deficit in regards to therapeutic measures and hence have difficulties with adherence to treatment protocols/ management plans. It is of utmost importance, and best practice, that the treatment team provides effective patient education and support during the learning phase.

However, there is little evidence and no published studies that describe and evaluate effective multidisciplinary educational interventions that target compliance/ adherence to the treatment plan in patients with VLU. Therefore the investigators propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trail.

Method/Design: Firstly, the development of an evidence based education intervention in collaboration with an expert panel and secondly a randomized controlled pilot study in one wound care outpatient clinic is proposed. Data will be analyzed using SPSS version 23. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data.

Discussion: The TIEIVLU will firstly develop an evidenced based educational intervention and secondly examine the feasibility of implementing this education intervention in a realistic care context in patients with VLU. The results will inform the final design of a following RCT which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy and hence reduces the negative outcomes of VLU would be beneficial to individual patients as well as society as a whole.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial.
   Probst S, Allet L, Depeyre J, Colin S, et al · · 2019 · cited 21× · PMID 31036037 · DOI 10.1186/s13063-019-3333-4