NCT04304937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

March 9, 2020

Last Update Submit

March 9, 2020

Conditions

Superficial Venous InsufficiencyQuality of LifeChange After Treatment

Keywords

Patient reported outcome measure

Outcome Measures

Primary Outcomes (1)

  • the short PROM is valid for measurement of quality of life and detects change caused by treatment

    baseline and 8 weeks

Study Arms (2)

Cohort 1

test-retest at baseline and 7 days later

Other: patient reported outcome measure

Cohort 2

test at baseline and 8 weeks post treatment

Other: patient reported outcome measure

Interventions

patient reported outcome measureOTHER

2 questionnaires are tested against each other

Cohort 1Cohort 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karlskoga venöst centrum

Karlskoga, Sweden

Location

Åderbråckscentrum

Malmo, Sweden

Location

Narvakliniken Åderbråck

Stockholm, Sweden

Location

MeSH Terms

Interventions

Patient Reported Outcome Measures

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 12, 2020

Study Start

January 1, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

SE(3)