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临床试验/NCT04096729
NCT04096729已完成不适用

Patients Commitment to Compression Therapy

Belarusian State Medical University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • hearing impairment, which could interfere with a telephone questionnaires

结局指标

主要结局

number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery

时间窗: 1 year

1-followed 2- did not followed

次要结局

  • number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery(1 year)

研究者

发起方
Belarusian State Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ihar Ihnatovich

Professor

Belarusian State Medical University

研究点 (2)

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