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NCT04304937 Clinical Trial

Validation of Swedish Short PROM för Venous Insufficiency

Quality of Life Clinical Trial

Official title:
Validation of a Swedish Version of a Short Patient-Reported-Outcome-Measure for Superficial Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04304937
Other study ID # 2017/1824 - 31/2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date October 31, 2019

Study information
Verified date March 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Validation of a new short Swedish patient reported outcome measure for superficial venous insufficiency. Analysis of its capacity to measure quality of life and its responsiveness to change caused by treatment.

Recruitment information / eligibility
Status Completed
Enrollment 257
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- agrees to participate, diagnosed with superficial venous insufficiency C2-C6

Exclusion Criteria:

- does not want to participate, less than C2, does not submit the answered questionnaires

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• patient reported outcome measure
2 questionnaires are tested against each other

Locations
Country Name City State
Sweden Karlskoga venöst centrum Karlskoga
Sweden Åderbråckscentrum Malmö
Sweden Narvakliniken Åderbråck Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska Institutet Skandinaviska Forskningsstiftelsen för Åderbråck och andra Vensjukdomar

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary the short PROM is valid for measurement of quality of life and detects change caused by treatment baseline and 8 weeks
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