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

The Impact of a Pluridisciplinary Education Program on Venous Leg Ulcer Size Reduction: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer; Interdisciplinary Communication; Patient Empowerment
• Intervention / Treatment: Other: Education

Detailed Description

Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate of 70% and a 60% risk of becoming chronic. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the health care system and society in general. The estimated VLU prevalence in the general population is 3%. Treatment cost for VLU is estimated to be 3% of overall health expenditure. Current therapeutic approaches are multifaceted and focus on reducing wound size and improving wound healing as well as preventing ulcer recurrence. Such approaches include compression therapy, leg elevation, specific ankle-exercises and a protein rich diet. 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. Therefore, it is of utmost importance that the treatment team provides effective patient education and support during the learning phase. 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.

Specific aims: The effectiveness of the intervention will be defined in terms of changes in behavior (altered adherence to compression therapy, elevation therapy, physical activity therapy, ankle exercise therapy, and protein supplement therapy), and in terms of VLU basic awareness acquisition and wound status evaluation. In addition, occurrence of recurrence after healing and incidence of complications (re-hospitalizations) will be measured (frequency and cost).

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 study participants will be consecutive patients of the participating clinics who fulfill the inclusion criteria. Wound care will be performed according to the hospital's standard clinical practice guidelines. Allocation to the intervention group (IG) or the control group (CG) will be concealed. The intervention will consist of VLU patient education care bundle giving patients an opportunity to learn about the use of compression bandages, wearing and putting on compression stockings, and will include the importance of physical activity, ankle exercises, leg elevation and a high-protein diet to healing outcomes. An educational brochure summarizing these aspects will be given to the patients of the IG. This group will be supervised by a study nurse, who will not be identical with the nurse in charge of the control group. Due to the intervention being an educational program, the study cannot be blinded either for the participants or the staff performing the intervention. 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. Additionally, it is in alignment with the National Strategy on the Prevention of Non-Communicable Diseases 2017 - 2024 establishing prevention work for people with enhanced risks and chronic conditions reinforcing protective factors such as diet and exercise. This pluridisciplinary study (engaging experts in nursing, physiotherapy and nutrition) associates two research centers with high-level expertise in the field of wound care that both successfully conducted and published research results.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • University Hospital Geneva
  • GE
    • Onex, GE, Switzerland, 1213
      • Cité Génération Maison de santé
  • VD
    • Lausanne, VD, Switzerland, 1005
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Valid informed consent is not or cannot be given

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Other: Education; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-care	Self-care score will be evaluated using the validated self care questionnaire (VeLUSET©_FR),	one year
Effective activity	Effective activity will be measured using GeneActiv device	one year
wound evaluation	Wound will be evaluated in terms of exudative status, smell, infection status and pain felt. The TIME strategy (T = tissue removal; I = infection control; M = moisture balance; E = edge advancement) proposed by the European Wound Management Association will be applied	one year
Adherence to lifestyle	Adherence to lifestyle prescriptions, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be evaluated using a short health questionnaire	one year
general nutritional status	General nutritional status of patients will be measured using the MNA® questionnaire, a validated assessment tool that identifies people malnourished or at risk of malnutrition	one year
protein intake	Daily protein intake of participants in g/kg of body weight will be estimated using FFQ questionnaire, a validated tool developed to assess mean nutrient intakes in the population	one year

Collaborators and Investigators

• Sponsor: School of Health Sciences Geneva
• Investigators: Principal Investigator: Sebastian E Probst, Prof, University of Applied Sciences and Arts Western Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: patient education
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: venous leg ulcer education

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No