Validation of Swedish Short PROM för Venous Insufficiency

NCT ID: NCT04304937

Last Updated: 2020-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Superficial Venous Insufficiency Quality of Life Change After Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

test-retest at baseline and 7 days later

patient reported outcome measure

Intervention Type OTHER

2 questionnaires are tested against each other

Cohort 2

test at baseline and 8 weeks post treatment

patient reported outcome measure

Intervention Type OTHER

2 questionnaires are tested against each other

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

patient reported outcome measure

2 questionnaires are tested against each other

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Skandinaviska Forskningsstiftelsen för Åderbråck och andra Vensjukdomar

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karolina Hultman

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karlskoga venöst centrum

Karlskoga, , Sweden

Site Status

Åderbråckscentrum

Malmo, , Sweden

Site Status

Narvakliniken Åderbråck

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017/1824 - 31/2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.