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Peripheral Vascular Disease and Health status

Peripheral Vascular Disease and Health status - DECREASE VIII

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37994
Enrollment
900
Registered
2008-11-19
Start date
2008-11-21
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral arterial disease

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Patient scheduled for non-cardiac vascular surgery -Patient older than 18 years -Patient have signed informed consent

Exclusion criteria

Exclusion criteria: -A life expectancy less than 12 months -Presence of severe psychopathological comorbidities (e.g., psychosis, suicidal ideation) -Severe cognitive impairment (Mini Mental Status Examination Score of 23 or lower) --Insufficient knowledge of the Dutch language.

Design outcomes

Primary

MeasureTime frame
The primary study parameter is health status. Health status will be measured by the translated Dutch version of the PAQ, an disease-specific instrument for assessing health status in patients with PAD, and the Dutch version of the EQ-5D, a standardized, generic instrument for describing and valuing health.

Secondary

MeasureTime frame
Delirium (scores on the Delirium Scale > 12); mortality (both cardiac and non-cardiac); morbidity (i.e. a composite of rehospitalisation due to failed grafts). Data for these endpoints will be retrieved from the patients' medical records and assessed 2 years after surgery, including also the date of the event.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)