Validation of Swedish Short PROM för Venous Insufficiency | NCT04304937

Studies
Validation of Swedish Short PROM för Venous Insufficiency

NCT04304937

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Mar 12, 2020Actual

Enrollment

257Actual

Phase

Not provided

Conditions

Superficial Venous Insufficiency
Quality of Life
Change After Treatment

Interventions

patient reported outcome measure

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Oct 31, 2019Actual

Completion Date

Oct 31, 2019Actual

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Mar 9, 2020

First Posted Date

Mar 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karolina Hultman, MD PhD, Karolinska InstitutetPrincipal Investigator

Lead Sponsor

Karolinska InstitutetOTHER

Collaborators

Name	Class
Skandinaviska Forskningsstiftelsen för Åderbråck och andra Vensjukdomar	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

257Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
patient reported outcome measure	Other	2 questionnaires are tested against each other	Cohort 1 Cohort 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karlskoga venöst centrum		Karlskoga			Sweden
Åderbråckscentrum

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000071066	Patient Reported Outcome Measures

Ancestor Terms

ID	Term
D019538	Health Care Surveys
D011795	Surveys and Questionnaires
D003625	Data Collection
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided