Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Leg Ulcer | Study protocol

A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial

Authors: Sebastian Probst, Lara Allet, Jocelyne Depeyre, Sophie Colin, Monika Buehrer Skinner

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Venous leg ulcers are slow-healing wounds with a high 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 healthcare system and society in general. The estimated leg ulcer prevalence in the general population is 1%. Treatment costs for leg ulcers are estimated to be 3% of overall health expenditure. Current therapeutic approaches are multifaceted and include compression therapy, leg elevation, specific ankle-exercises and a protein diet. They require an interdisciplinary team of health care professionals. Approximately 70% of patients have a knowledge deficit with 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 is little evidence and no published studies that describe and evaluate effective interdisciplinary educational interventions that target compliance/adherence to the treatment plan in patients with leg ulcers. We therefore propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trial.

Method/Design

First, the development of an evidence-based educational intervention in collaboration with an expert panel is proposed and second, a randomized controlled feasibility study in a wound-care outpatient clinic. Eligible patients (n = 20) with leg ulcers will be randomized to receive either interdisciplinary education and usual care or only usual care, for 12 weeks. Data will be analyzed using SPSS version 25. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data.

Discussion

We will first develop an evidenced-based educational intervention and second, we will examine the feasibility of implementing this educational intervention in a realistic care context in patients with leg ulcers. The results will inform the final design of a subsequent randomized controlled trial, which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy would be beneficial to individual patients and to society as a whole.

Trial registration

ClinicalTrials.gov, NCT03454698. Registered on 6 March 2018.
Appendix
Available only for authorised users
Literature
1.
Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof PC, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs. 2004;13(3):341–54.CrossRef
2.
Heinen MM, van Achterberg T, op Reimer WS, van de Kerkhof PC, de Laat E. Venous leg ulcer patients: a review of the literature on lifestyle and pain-related interventions. J Clin Nurs. 2004;13(3):355–66.CrossRef
3.
Graham ID, Harrison MB, Nelson EA, Lorimer K, Fisher A. Prevalence of lower-limb ulceration: a systematic review of prevalence studies. Adv Skin Wound Care. 2003;16(6):305–16.CrossRef
4.
Harrisson MB, Graham ID, Friedberg E, Lorimer K, Vandevelde CS. Assessing the population with leg and foot ulcers. Canadian Nurse. 2001;97:18–23.
5.
Abbade LP, Lastoria S, de Almeida Rollo H, Stolf HO. A sociodemographic, clinical study of patients with venous ulcer. Int J Dermatol. 2005;44(12):989–92.CrossRef
6.
McDaniel HB, Marston WA, Farber MA, Mendes RR, Owens LV, Young ML, et al. Recurrence of chronic venous ulcers on the basis of clinical, etiologic, anatomic, and pathophysiologic criteria and air plethysmography. J Vasc Surg. 2002;35(4):723–8.CrossRef
7.
Finlayson K, Wu ML, Edwards HE. Identifying risk factors and protective factors for venous leg ulcer recurrence using a theoretical approach: a longitudinal study. Int J Nurs Stud. 2015;7:52(6):1042-51.CrossRef
8.
Saha SP, Whayne TF Jr, Mukherjee DP. Current management of peripheral vascular disease: where is the evidence? Cardiovasc Hematol Agents Med Chem. 2011;9(2):128–36.CrossRef
9.
Posnett J, Gottrup F, Lundgren H, Saal G. The resource impact of wounds on health-care providers in Europe. J Wound Care. 2009;18(4):154–61.CrossRef
10.
11.
12.
Australian and New Zealand Wound Managment Associations. Australian and New Zealand Clinical practive guideline for prevention and managment of venous leg ulcers. 2011.
13.
Association for the Advancement of Wound Care. Association for the Advancement of Wound Care (AAWC) venous ulcer guideline. 2010.
14.
SIGN (GB) - Scottish Intercollegiate Guidelines Network. Managment of chronic venous leg ulcers (SIGN CPG 120). 2010.
15.
National Institute for Health and Care Excellence (NICE). Varicose veins in the legs. The diagnosis and management of varicose veins. 2013.
16.
Franks P, Barker J, Collier M, Gethin G, Haesler E, Jawien A, et al. Management of patients with venous leg ulcer: challenges and current best practice. J Wound Care. 2016;25(Suppl 6):1–67.CrossRef
17.
Van Hecke A, Grypdonck M, Defloor T. Interventions to enhance patient compliance with leg ulcer treatment: a review of the literature. J Clin Nurs. 2008;17(1):29–39.PubMed
18.
Moffatt C, Kommala D, Dourdin N, Choe Y. Venous leg ulcers: patient concordance with compression therapy and its impact on healing and prevention of recurrence. Int Wound J. 2009;6(5):386–93.CrossRef
19.
Edwards LM, Moffatt CJ, Franks PJ. An exploration of patients' understanding of leg ulceration. J Wound Care. 2002;11(1):35–9.CrossRef
20.
Finlayson K, Edwards H, Courtney M. The impact of psychosocial factors on adherence to compression therapy to prevent recurrence of venous leg ulcers. J Clin Nurs. 2010;19(9–10):1289–97.CrossRef
21.
Van Hecke A, Grypdonck M, Beele H, Vanderwee K, Defloor T. Adherence to leg ulcer lifestyle advice: qualitative and quantitative outcomes associated with a nurse-led intervention. J Clin Nurs. 2011;20(3–4):429–43.CrossRef
22.
Heinen MM, Persoon A, van de Kerkhof P, Otero M, van Achterberg T. Ulcer-related problems and health care needs in patients with venous leg ulceration: a descriptive, cross-sectional study. Int J Nurs Stud. 2007;44(8):1296–303.CrossRef
23.
Heinen M, Borm G, van der Vleuten C, Evers A, Oostendorp R, van Achterberg T. The Lively Legs self-management programme increased physical activity and reduced wound days in leg ulcer patients: results from a randomized controlled trial. Int J Nurs Stud. 2012;49(2):151–61.CrossRef
24.
Brooks J, Ersser SJ, Lloyd A, Ryan TJ. Nurse-led education sets out to improve patient concordance and prevent recurrence of leg ulcers. J Wound Care. 2004;13(3):111–6.CrossRef
25.
26.
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377–81.CrossRef
27.
Van Hecke A, Verhaeghe S, Grypdonck M, Beele H, Flour M, Defloor T. Systematic development and validation of a nursing intervention: the case of lifestyle adherence promotion in patients with leg ulcers. J Adv Nurs. 2011;67(3):662–76.CrossRef
28.
Kelechi TJ, Mueller M, Spencer C, Rinard B, Loftis G. The effect of a nurse-directed intervention to reduce pain and improve behavioral and physical outcomes in patients with critically colonized/infected chronic leg ulcers. J Wound Ostomy Continence Nurs. 2014;41(2):111–21.CrossRef
29.
Casey G. Nutritional support in wound healing. Nurs Stand. 2003;17(23):55–8.CrossRef
30.
MacKay D, Miller AL. Nutritional support for wound healing. Altern Med Rev. 2003;8(4):359–77.PubMed
31.
McDaniel JC, Kemmner KG, Rusnak S. Nutritional profile of older adults with chronic venous leg ulcers: a pilot study. Geriatr Nurs. 2015;31:36(5):381-6.CrossRef
32.
Milne AC, Potter J, Vivanti A, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2009;2:CD003288.
33.
Wilkinson EA. Oral zinc for arterial and venous leg ulcers. Cochrane Database Syst Rev. 2014;9:CD001273.
34.
Van Hecke A, Verhaeghe S, Grypdonck M, Beele H, Defloor T. Processes underlying adherence to leg ulcer treatment: a qualitative field study. Int J Nurs Stud. 2011;48(2):145–55.CrossRef
35.
Keller-Senn A, Probst S, Mahrer Imhof R, Imhof L. Nurse-led education programme enhancing foot care self-efficacy in high-risk diabetes population. Int Diabetes Nurs. 2015;12:74–8.CrossRef
36.
Lee JY, Yoo KH, Kim DK, Kim SH, Kim TE, Kim TH, et al. Effects of educational interventions for chronic airway disease on primary care. J Korean Med Sci. 2016;31(7):1069–74.CrossRef
37.
Bobridge A, Sandison S, Paterson J, Puckridge P, Esplin M. A pilot study of the development and implementation of a 'best practice' patient information booklet for patients with chronic venous insufficiency. Phlebology. 2011;26(8):338–43.CrossRef
38.
O'Brien JA, Finlayson KJ, Kerr G, Edwards HE. Testing the effectiveness of a self-efficacy based exercise intervention for adults with venous leg ulcers: protocol of a randomised controlled trial. BMC Dermatol. 2014;14:16.CrossRef
39.
Klonizakis M, Tew GA, Gumber A, Crank H, King B, Middleton G, et al. Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomized controlled feasibility trial. Br J Dermatol. 2018;178(5):1072–82.CrossRef
40.
41.
Kan YM, Delis KT. Hemodynamic effects of supervised calf muscle exercise in patients with venous leg ulceration: a prospective controlled study. Arch Surg. 2001;136(12):1364–9.CrossRef
42.
Yang D, Vandongen YK, Stacey MC. Effect of exercise on calf muscle pump function in patients with chronic venous disease. Br J Surg. 1999;86(3):338–41.CrossRef
43.
O'Brien J, Edwards H, Finlayson K, Kerr G. Understanding the relationships between the calf muscle pump, ankle range of motion and healing for adults with venous leg ulcers: a review of the literature. Wound Pract Res. 2002;20(2):80–5.
44.
Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, et al. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009;41(7):1510–30.CrossRef
45.
Kaewkannate K, Kim S. A comparison of wearable fitness devices. BMC Public Health. 2016;16(1):433.CrossRef
46.
Widmer LK, Stähelin HB, Nissen C, Da Silva A. Venen-, arterien-krankheiten, koronare herzkrankheiten bei berufstätigen. Bern: Hans Huber Verlag; 1981.
47.
Metadata
Title
A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial
Authors
Sebastian Probst
Lara Allet
Jocelyne Depeyre
Sophie Colin
Monika Buehrer Skinner
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3333-4

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial

Correction

Correction to: Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial

Study protocol

HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya

Study protocol

Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)

Study protocol

Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial

Study protocol

Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial