Validation of Swedish Short PROM för Venous Insufficiency

Completed

• Conditions: Superficial Venous Insufficiency; Quality of Life; Change After Treatment
• Interventions: Other: patient reported outcome measure

• Registration Number: NCT04304937
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Study First Posted: 2020-03-12
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	patient reported outcome measure	test-retest at baseline and 7 days later
Cohort 2	patient reported outcome measure	test at baseline and 8 weeks post treatment

Primary Outcome Measures

Name	Time	Method
the short PROM is valid for measurement of quality of life and detects change caused by treatment	baseline and 8 weeks

Trial Locations

Locations (3)

Karlskoga venöst centrum; 🇸🇪 Karlskoga, Sweden

Narvakliniken Åderbråck; 🇸🇪 Stockholm, Sweden

Åderbråckscentrum; 🇸🇪 Malmö, Sweden