Patients Commitment to Compression Therapy

NCT04096729 — Completed, 400 participants, Belarusian State Medical University

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RegistryNCT04096729, acronym POMP
StatusCompleted
Study typeObservational
Enrollment400 (Actual)
SponsorBelarusian State Medical University (Other)
ConditionsCompression; Vein, Patient Satisfaction
Interventionscompression stockings (Other)
Datesstart 2019-10-01, primary completion 2020-01-01, completion 2021-01-26, first posted 2019-09-20, last updated 2023-02-10
Locations2 sites in Belarus

Related Papers Related Patents Related Grants Related Experts
All trials for Compression; Vein All trials for Patient Satisfaction All trials of compression stockings

-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.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
patients who have consulted and need compression therapy usingOther: compression stockings1\) age from 18 to 75 years; 2) compression therapy prescribed by a phlebologist. The exclusion criterion is hearing impairment, which could interfere with a telephone questionnaires.
  • compression stockings (Other): patients will be prescribed compression therapy for varicose veins of the legs using compression stockings

+Outcome measures

Primary outcomes

  • number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery [1 month]: 1-followed 2- did not followed
  • number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery [1 year]: 1-followed 2- did not followed

Secondary outcomes

  • number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery [1 month]: Score in points from 0 to 10, where 10 is the maximum level of satisfaction
  • number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery [1 year]: Score in points from 0 to 10, where 10 is the maximum level of satisfaction

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (2)

FacilityCityCountryStatus
Educational Institution"Belarusian State Medical University"Minsk, Dzerzhinski Ave., 83Belarus
Belarusian State Medical UniversityMinskBelarus

+Publications

  • 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. PMID 25920631
  • 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. PMID 23683393
  • 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. PMID 18063393

+Investigators