Clinical trial NCT06812520: Educational Intervention to Promote Compression Therapy in People With Venous Ulcer
Official title: Educational Intervention to Promote Compression Therapy in People With Venous Ulcer: Pilot and Non-randomized Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Varicose Ulcer
Keywords: Varicose ulcer
adherence
Patient education
Acceptability
Lead sponsor: Universidad de Concepcion
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Acceptability assessment will be carried out by applying the TAP scale
timeFrame: 12 weeks
measure: Adherence to compression therapy
timeFrame: 12 weeks
measure: area of ulceration
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hualpen
country: Chile
facility: Departamento de Salud de la comuna de Hualpen
state: Biobio
Study officials:
affiliation: Universidad de Concepcion
name: Alide A Salazar, Doctor
role: STUDY_DIRECTOR
References: