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Clinical Trials/NCT03454698
NCT03454698
Completed
Not Applicable

A Targeted Interprofessional Education Intervention to Address Therapeutic Adherence of Venous Leg Ulcer Persons (TIEIVLU): Study Protocol for a Randomized Controlled Trail

School of Health Sciences Geneva1 site in 1 country13 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Interprofessional Education for Venous Leg Ulcer Patients
Sponsor
School of Health Sciences Geneva
Enrollment
13
Locations
1
Primary Endpoint
acceptability of an interprofessional education for venous leg ulcer patients
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

Background: 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. The signs and symptoms of VLU are not only a burden on those who are affected by it but also on the health care system and society in general. While the prevalence of VLU in the general population is 1%, it rises to 3% in the over 80 age group. The cost of treatment and care for VLU is estimated to be 2 to 3% of the overall health expenditure. 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 person 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
School of Health Sciences Geneva
Responsible Party
Principal Investigator
Principal Investigator

Sebastian Probst

Clinical Professor

School of Health Sciences Geneva

Eligibility Criteria

Inclusion Criteria

  • An existing open venous leg ulcer
  • An ankle brachial pressure index (ABPI) between 0.8 and 1.3
  • Age over 18 years
  • Proficiency in the French language

Exclusion Criteria

  • Valid informed consent is not or cannot be given

Outcomes

Primary Outcomes

acceptability of an interprofessional education for venous leg ulcer patients

Time Frame: 3 months

acceptability of this elaborated interprofessional education

Study Sites (1)

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