Educational Intervention to Promote Compression Therapy in People with Venous Ulcer

Educational Intervention to Promote Compression Therapy in People with Venous Ulcer: Pilot and Non-randomized Feasibility Study

Background: Chronic Venous Disease (CVD) is a condition that affects a significant percentage of the world's population, and can range from mild symptoms such as telangiectasias to severe manifestations such as venous ulcers (VU). The gold standard UV treatment is compression therapy, however, people's adherence to it is variable due to several associated factors: physical, aesthetic and lack of education about compression therapy. Compression therapy acts by increasing interstitial pressure, thus decreasing the caliber of superficial and deep veins, decreasing venous pressure and edema . The study originates from clinical practice where it is observed that people do not adhere or abandon compression treatment, a situation that agrees with the literature review, so new trials on strategies to increase adherence are required (20). The proposed intervention: promoting adherence has a theoretical basis, a conceptual basis and an empirical basis. a) Theoretical basis: it incorporates the theory of self-care of chronic diseases with the incorporation of symptoms, due to the importance that these have for those who present them and for the self-care process, particularly with regard to maintaining self-care and adherence; in addition, the theoretical basis related to health interventions is incorporated. b) Conceptual basis: founded on vascular alterations that lead to the loss of skin integrity with the consequent imbalance: pain, edema, exudate, bad odor, so it is necessary for these to be recognized by patients and then by the professionals who serve them. c) Empirical basis: it incorporates compression therapy, considered the gold standard in the treatment of people with venous ulcers. Based on the evidence analyzed, the Lively Leg intervention developed by Heinen et al. was chosen as a basis. 2012, to which modifications were introduced based on the self-care theory, since, together, the symptoms of the ulcer, the associated chronic diseases and the characteristics of the people intervene in their adherence to compression therapy. The objective of the study is to evaluate the feasibility and preliminary effect of an educational intervention on adherence to compression therapy, pain and ulceration of the area in users who have a venous ulcer, in the commune of Hualpen, Chile, during the year 2024.

Study Overview

• Status: Recruiting
• Conditions: Varicose Ulcer
• Intervention / Treatment: Behavioral: Educational intervention in adherence

Detailed Description

Type of study design A feasibility study will be carried out. For this purpose, a study will be carried out without a control group with a pre- and post-test comparison, since it corresponds to phase I of development of an intervention study.

Study hypotheses.

• Users who have a venous ulcer and compression therapy, after the educational intervention, have a smaller area of ulceration than at the beginning of the intervention.
• 50% of users who present venous ulcer and compression therapy show adherence to therapy after the educational intervention.
• Users who have a venous ulcer and compression therapy, after the educational intervention, have a lower intensity of pain than at the beginning of the intervention.
• Users who present with venous ulcer and compression therapy evaluate the acceptability of an educational intervention with a score greater than 2.

who can participate? People over 20 years of age who have a venous ulcer, registered in the commune of Hualpen who meet the inclusion and exclusion criterio.

What are possible risks and benefits of participating? The main risk is presenting some psychoemotional alteration due to possible experiences and experiences or simply not wanting to continue, which would constitute a sufficient reason to suspend the interview, and if psychoemotional symptoms are presented, crisis care will be provided and then referred to the health Center, for your attention and which would constitute sufficient reason to suspend the interview.

The benefits of participation involve all those that are associated with ulcer healing: decrease or closure of the ulcer, decrease in pain, decrease in wound exudate, increase in control of symptoms and signs of venous ulcer, less quantity of cures, improve quality of life, greater mobility.

Patient recruitment will be carried out for convenience; the number of participants to be entered is 22, which was calculated with an estimated loss of 20%.

Recruitment of users will begin in December and is estimated to take place over 2 to 3 months.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingrid X Briones, candidate for master's degree; Phone Number: +56973383473; Email: ingrid.ximena.briones@gmail.com
• Study Contact Backup: Name: Alide A Salazar, doctor; Phone Number: 56412207065; Email: alisalaz@udec.cl

Study Locations

• Chile
  • Biobio
    • Hualpen, Biobio, Chile, 4601645
      • Recruiting
      • Departamento de Salud de la comuna de Hualpen
      • Contact: Claudia A Castell, Director; Phone Number: 56412419957; Email: ccastell@hualpenciudad.cl
      • Contact: Carolina Navarrete, nurse; Phone Number: 56412426787; Email: cnavarrete@hualpenciudad.cl
      • Contact: Ingrid X Briones L, candidate for master's degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult with a grade 2 venous ulcer who is admitted to compression treatment
• Alphabet.
• Management of the Spanish language

Exclusion Criteria:

• Adult who presents a grade 1 venous ulcer
• Adult who presents cognitive impairment (determined by review of clinical record by treating nurse)
• Diagnoses of: dementia,
• Diagnoses Alzheimer's disease
• mental retardation or cognitive deficit
• Adult with severe dependency (determined by review of clinical record by treating nurse) Adult with venous ulcer with cancer undergoing chemotherapy (determined by review of clinical record by treating nurse.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational intervention group for adherence; The study only has the intervention group who will receive the educational activity to improve adherence to compression therapy.	Behavioral: Educational intervention in adherence; An educational intervention of 4 face-to-face sessions will be carried out as a complement to the care provided by professionals to users with venous ulcers, which consists of the advanced healing procedure that includes compressive bandaging of the venous ulcer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to compression therapy	Adherence can be defined as the degree to which patients follow the instructions given to them by different professionals. In this study, adherence to compression therapy will be assessed on each occasion that they attend visits and those who have a percentage of adherence to therapy equal to or above 75% in the 12-week period will be categorized as adherent.	12 weeks
area of ulceration	Surface of the wound that is open, the evaluation is carried out by measuring in centimeters the length at its greatest and width at its largest ends and then multiplying both, with this the ulceration area is obtained.	12 weeks
Acceptability assessment will be carried out by applying the TAP scale	Acceptability will be measured through the Questionnaire developed by Sidani "Treatment Acceptability and Preference" (TAP) adapted to Chilean Spanish. A total scale score is computed as the mean of the four items' scores to reflect level of perceived treatment acceptability. The possible range for the total scale score is 0 to 4, with high score reflecting high acceptability	12 weeks

Collaborators and Investigators

• Sponsor: Alide Salazar Molina
• Investigators: Study Director: Alide A Salazar, Doctor, Universidad de Concepcion

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: February 1, 2025
• First Submitted That Met QC Criteria: February 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: adherence; Patient education; Acceptability; Varicose ulcer
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Ulcer; Varicose Ulcer
• Other Study ID Numbers: CEBB1659-2024

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
• product manufactured in and exported from the U.S.: No