Patient Satisfaction Clinical Trial
— POMPOfficial title:
Patients Commitment to Compression Therapy
NCT number | NCT04096729 |
Other study ID # | 1-30082019 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | January 26, 2021 |
Verified date | February 2023 |
Source | Belarusian State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | January 26, 2021 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belarus | Belarusian State Medical University | Minsk | |
Belarus | Educational Institution"Belarusian State Medical University" | Minsk | Dzerzhinski Ave., 83 |
Lead Sponsor | Collaborator |
---|---|
Belarusian State Medical University |
Belarus,
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. — View 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. — View 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. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):495. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery | Score in points from 0 to 10, where 10 is the maximum level of satisfaction | 1 month | |
Secondary | number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery | Score in points from 0 to 10, where 10 is the maximum level of satisfaction | 1 year |
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