Superficial Venous InsufficiencyNCT04304937
Validation of Swedish Short PROM för Venous Insufficiency
An observational study of Superficial Venous Insufficiency and Quality of Life, run by Karolinska Institutet at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Superficial Venous Insufficiency, Quality of Life, Change After Treatment
- What is being tested?
- patient reported outcome measure
- How many people
- 257 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Jan 2018to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients at chosen clinics diagnosed with superficial venous insufficiency C2-C6
Who may be able to join
- agrees to participate, diagnosed with superficial venous insufficiency C2-C6
Who cannot join
- does not want to participate, less than C2, does not submit the answered questionnaires
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Karlskoga venöst centrum
Karlskoga
Åderbråckscentrum
Malmö
Narvakliniken Åderbråck
Stockholm
About this study
Official title: 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.
- Being tested
- patient reported outcome measure
- Keywords
- Patient reported outcome measure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient reported outcome measureOther
2 questionnaires are tested against each other
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | test-retest at baseline and 7 days later Receives: Other: patient reported outcome measure | |
| Cohort 2 | test at baseline and 8 weeks post treatment Receives: Other: patient reported outcome measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
the short PROM is valid for measurement of quality of life and detects change caused by treatment
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Jan 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Skandinaviska Forskningsstiftelsen för Åderbråck och andra Vensjukdomar
- Responsible party
- Principal investigator, Karolina Hultman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304937
- Sponsor's protocol ID
- 2017/1824 - 31/2
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Swedish Version of a Short Patient-Reported-Outcome-Measure for Superficial Venous Insufficiency
- ClinicalTrials.gov ID
- NCT04304937
- Acronym / sponsor ID
- 2017/1824 - 31/2
- Keywords
- Patient reported outcome measure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Skandinaviska Forskningsstiftelsen för Åderbråck och andra Vensjukdomar
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: patient reported outcome measuretest-retest at baseline and 7 days later |
| Cohort 2 | – | Other: patient reported outcome measuretest at baseline and 8 weeks post treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients at chosen clinics diagnosed with superficial venous insufficiency C2-C6
Key inclusion criteria (1 listed)
- agrees to participate, diagnosed with superficial venous insufficiency C2-C6
Key exclusion criteria (1 listed)
- does not want to participate, less than C2, does not submit the answered questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient reported outcome measure2 questionnaires are tested against each other | Other | Cohort 1, Cohort 2 |
Primary outcome
the short PROM is valid for measurement of quality of life and detects change caused by treatment
Time frame: baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Venous Insufficiency and Quality of Life, run by Karolinska Institutet at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the short PROM is valid for measurement of quality of life and detects change caused by treatment (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.