NCT04096729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2021

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

September 16, 2019

Last Update Submit

February 9, 2023

Conditions

Compression; VeinPatient Satisfaction

Keywords

commitment to treatmentcompression stockingsvaricose veins

Outcome Measures

Primary Outcomes (2)

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

    1-followed 2- did not followed

    1 month

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

    1-followed 2- did not followed

    1 year

Secondary Outcomes (2)

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

    1 month

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

    1 year

Study Arms (1)

patients who have consulted and need compression therapy using

1\) 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.

Other: compression stockings

Interventions

compression stockingsOTHER

patients will be prescribed compression therapy for varicose veins of the legs using compression stockings

patients who have consulted and need compression therapy using

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with varicose veins of the legs

You may qualify if:

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

You may not qualify if:

  • hearing impairment, which could interfere with a telephone questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Educational Institution"Belarusian State Medical University"

Minsk, Dzerzhinski Ave., 83, 220116, Belarus

Location

Belarusian State Medical University

Minsk, 220116, Belarus

Location

Related Publications (3)

  • 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: 25920631BACKGROUND

  • 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: 23683393BACKGROUND

  • 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: 18063393BACKGROUND

MeSH Terms

Conditions

Patient SatisfactionVaricose Veins

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Study Officials

  • Ihar Ihnatovich, Prof

    Belarusian State Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 20, 2019

Study Start

October 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 26, 2021

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)