Validation of Swedish Short PROM för Venous Insufficiency

March 9, 2020 updated by: Karolina Hultman, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Karlskoga, Sweden
        • Karlskoga venöst centrum
      • Malmö, Sweden
        • Åderbråckscentrum
      • Stockholm, Sweden
        • Narvakliniken Åderbråck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive patients at chosen clinics diagnosed with superficial venous insufficiency C2-C6

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
test-retest at baseline and 7 days later
Other: patient reported outcome measure
2 questionnaires are tested against each other
Cohort 2
test at baseline and 8 weeks post treatment
Other: patient reported outcome measure
2 questionnaires are tested against each other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the short PROM is valid for measurement of quality of life and detects change caused by treatment
Time Frame: baseline and 8 weeks
baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Skandinaviska Forskningsstiftelsen för Åderbråck och andra Vensjukdomar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/1824 - 31/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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