The Impact of a Pluridisciplinary Education Program on Venous Leg Ulcer Size Reduction

NCT04019340 | Completed DMC

• 1 other identifier: venous leg ulcer education
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 3

Brief Summary

Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate of 70% and a 60% risk of becoming chronic. The estimated VLU prevalence in the general population is 3%. Current therapeutic approaches are multifaceted and focus on reducing wound size and improving wound healing as well as preventing ulcer recurrence. They require a pluridisciplinary team of health care professionals from the domains of nursing, medicine, physiotherapy and nutrition. Approximately 70% of VLU patients have a knowledge deficit in regards to therapeutic measures and have difficulties with adherence to treatment protocols. However, there are no published studies describing and evaluating the impact of pluridisciplinary educational interventions on adherence to the treatment plan and wound size reduction in VLU patients. Overall objectives: The objectives of the projected study are to evaluate the effectiveness of nurse-led intervention for high-risk patients with VLU in terms of patient knowledge/therapy adherence and to measure the impact of this intervention on wound size reduction and its evolution over time. Methodology of the planned study: An international multicenter randomized controlled trial with 248 participants in three Swiss French (n= 124) and two Australian (n=124) wound clinics is proposed. The sample size assumptions are based on a two-sided alpha level of 0.05, power of 0.8, and a medium effect size. Univariate and bivariate analysis will be conducted according to the data level and distribution. Expected results and impact: The findings of this study will generate new knowledge and the results will contribute to VLU clinical practice guidelines to enhance patient adherence to therapy. Our results will not only help improving patients' quality of life, but also contribute to reducing health expenditure.

Conditions

Patient Empowerment; Venous Leg Ulcer; Interdisciplinary Communication

Keywords

patient education

Outcome Measures

Primary Outcomes (1)

• Wound size reduction

  Measurement of the impact of a pluridisciplinary educative program on the relative Reduction (in %) of wound size in patients with VLU. Wound size will be measured using WoundWorks® imaging device

  one year

Secondary Outcomes (6)

• Self-care

  one year

• Effective activity

  one year

• wound evaluation

  one year

• Adherence to lifestyle

  one year

• general nutritional status

  one year

Study Arms (2)

Control

NO INTERVENTION

Usual care for patients in the CG is defined as visiting the outpatient wound clinic as prescribed by the physician. Wound size measurement, wound care (including dressing and inspection), and questionnaires will be provided by the institute's nurses.

Education

OTHER

Usual care as described for the CG will also be provided to the IG (visit to the outpatient wound clinic as prescribed by the physician). Wound size measurement, wound care (including dressing and inspection), and questionnaires will be provided by the institute's nurses. After baseline data collection (T0) and random allocation to the intervention group, this usual care will be enhanced by a pluridisciplinary educational program

Other: Education

Interventions

Education OTHER

Usual care as described for the CG will also be provided to the IG. Wound size measurement, wound care, and questionnaires will be provided by the institute's nurses. Usual care will be enhanced by a pluridisciplinary educational program

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older,
• an existing diagnosed open VLU,
• ulcer surface \>5 cm2 and \> 15 cm2,
• proficiency in the French language

You may not qualify if:

• Valid informed consent is not or cannot be given

Sponsors & Collaborators

• School of Health Sciences Geneva: lead

Study Sites (3)

Cité Génération Maison de santé

Onex, Canton of Geneva, 1213, Switzerland

Location

Centre hospitalier universitaire vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

Location

University Hospital Geneva

Geneva, 1206, Switzerland

Location

Related Publications (1)

• Probst S, Allet L, Depeyre J, Colin S, Buehrer Skinner M. A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial. Trials. 2019 Apr 29;20(1):243. doi: 10.1186/s13063-019-3333-4.

  PMID: 31036037 BACKGROUND

MeSH Terms

Conditions

Patient Participation; Varicose Ulcer

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Sebastian E Probst, Prof

  University of Applied Sciences and Arts Western Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in tissue viability and wound care

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: February 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)