Clinical trial NCT04096729: Patients Commitment to Compression Therapy
Official title: Patients Commitment to Compression Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Compression; Vein
Patient Satisfaction
Keywords: commitment to treatment
compression stockings
varicose veins
Lead sponsor: Belarusian State Medical University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with varicose veins of the legs

Brief summary: The study Patients Commitment to compression therapy (POMP) is observational, prospective. After the Phlebologist consultation after 1 month and 1 year, a telephone questionnaire is carried out for the patients included in the study with the involvement of a company specializing in conducting a telephone questionnaire. Patients will be interviewed about the implementation of the doctor's recommendations regarding compression therapy over a period 1 month and 1 year.

Detailed description: Phlebologists will include in the study patients who have consulted and need compression therapy using a compression hosiery. Patients are recommended compression hosiery that meet RAL-GZ 387, Oeko-Tex Standart 100. At the same time, the design of this study does not provide for restrictions on the acquisition by patients of other type compression hosiery.

Inclusion of patients in the study is carried out only after obtaining written informed consent from them for data registration and subsequent telephone questionnaires. Demographic, anamnestic, sociological data, such as educational level, labor characteristics (heavy physical labor, prolonged orthostasis, prolonged sitting position) recorde in the patient's individual card. Women provide information on the number of births, menopause, use of hormone replacement therapy at the time of the study. A diagnosis performed for each lower limb according to only the clinical part of the CEAP classification without other details. The phlebologist individually for each patient determines the mode of wearing compression hosiery. In addition to compression therapy, it is possible to prescribe any other type of drug and / or surgical treatment. In the subsequent analysis, data on the lower limb with more severe manifestations of venous insufficiency are used.

Table 1. Main characteristics of the patients included in the study Class С Age, years Sex Мail/Femail University education Yes / No Prolonged orthostasis Yes / No Hard physical labor Yes / No Prolonged sitting position Yes / No Family history of Chronic Vein Disease Yes / No A history of Venous Thromboembolism Yes / No Smoking Yes / No History of childbirth (among women) Number 0-.... Hormonal contraception / hormone replacement therapy (among women) Yes / No

1 month and 1 year after the consultation patients will interrogate about the implementation of the doctor's recommendations regarding compression therapy (Tabl. 2) Table 2. Questions included in the telephone survey You have been prescribed compression hosiery. Have you bought it?

* Did not buy
* Bought immediately after a visit to the doctor
* Not immediately bought (after how many days) Which product did you buy?
* Knee socks
* Stockings
* One-leg stocking with zipper at the waist (monostocking)
* Tights Do you follow the recommended doctor's regimen for wearing compression hosiery? - ---
* Yes
* No

If you did not comply with the compression hosiery pattern, then why?

* Too difficult to put on / take off
* Uncomfortable to wear
* Hot to wear
* Itching when used
* Ugly
* Does not help
* It gets worse when I start wearing
* I can not wash the product every day
* Other (with explanation) Did you wear compression hosiery before being included in the study?
* Yes
* No What kind of compression hosiery had you wear before you entered the study?
* Knee socks
* Stockings
* One-leg stocking with zipper at the waist (monostocking)
* Tights Compression class
* 1
* 2
* 3

How are you satisfied with the effect of the using compression hosiery? Score in points from 0 to 10, where 10 is the maximum level of satisfaction

How are you satisfied with the comfort of the using compression hosiery? Score in points from 0 to 10, where 10 is the maximum level of satisfaction

How are you satisfied with the quality of the using compression hosiery? Score in points from 0 to 10, where 10 is the maximum level of satisfaction

Eligibility criteria: Inclusion Criteria:

* varicose veins of the legs and compression therapy prescribed by a phlebologist

Exclusion Criteria:

* hearing impairment, which could interfere with a telephone questionnaires

Primary outcomes:
measure: number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery
timeFrame: 1 month
measure: number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery
timeFrame: 1 year
Secondary outcomes:
measure: number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery
timeFrame: 1 month
measure: number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery
timeFrame: 1 year
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Educational Institution"Belarusian State Medical University"
state: Dzerzhinski Ave., 83
city: Minsk
country: Belarus
facility: Belarusian State Medical University
Study officials:
affiliation: Belarusian State Medical University
name: Ihar Ihnatovich, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittens C, Davies AH, Baekgaard N, Broholm R, Cavezzi A, Chastanet S, de Wolf M, Eggen C, Giannoukas A, Gohel M, Kakkos S, Lawson J, Noppeney T, Onida S, Pittaluga P, Thomis S, Toonder I, Vuylsteke M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Koncar I, Lindholt J, de Ceniga MV, Vermassen F, Verzini F, Document Reviewers, De Maeseneer MG, Blomgren L, Hartung O, Kalodiki E, Korten E, Lugli M, Naylor R, Nicolini P, Rosales A. Editor's Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2015 Jun;49(6):678-737. doi: 10.1016/j.ejvs.2015.02.007. Epub 2015 Apr 25. No abstract available.
citation: Mosti G, Partsch H. Bandages or double stockings for the initial therapy of venous oedema? A randomized, controlled pilot study. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):142-8. doi: 10.1016/j.ejvs.2013.04.015. Epub 2013 May 15.
citation: Amsler F, Blattler W. Compression therapy for occupational leg symptoms and chronic venous disorders - a meta-analysis of randomised controlled trials. Eur J Vasc Endovasc Surg. 2008 Mar;35(3):366-72. doi: 10.1016/j.ejvs.2007.09.021. Epub 2007 Dec 11.