Educational Intervention to Promote Compression Therapy in People With Venous Ulcer

NCT06812520 | Recruiting DMC

• 1 other identifier: CEBB1659-2024
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicose Ulcer

Keywords

Varicose ulcer; adherence; Patient education; Acceptability

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (1)

Educational intervention group for adherence

EXPERIMENTAL

The study only has the intervention group who will receive the educational activity to improve adherence to compression therapy.

Behavioral: Educational intervention in adherence

Interventions

Educational intervention in adherence BEHAVIORAL

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.

Educational intervention group for adherence

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Alide Salazar Molina: lead

Study Sites (1)

Departamento de Salud de la comuna de Hualpen

Hualpén, Región del Biobío, 4601645, Chile

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alide A Salazar, Doctor

  Universidad de Concepcion

  STUDY DIRECTOR

Central Study Contacts

Ingrid X Briones, candidate for master's degree

CONTACT

+56973383473; ingrid.ximena.briones@gmail.com

Alide A Salazar, doctor

CONTACT

56412207065; alisalaz@udec.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ingrid Briones Luengo

Model Details: 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 Record Dates

• First Submitted: February 1, 2025
• First Posted: February 6, 2025
• Study Start: November 29, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)