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Structured modified Rankin Scale study

A prospective study to investigate the outcomes in different assessment methods of the Modified Rankin Scale (mRS) in patients with an aneurysmal subarachnoid hemorrhage (SAH).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26434
Enrollment
120
Registered
2019-07-08
Start date
2018-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Subarachnoid hemorrhage

Interventions

During the regular outpatient follow-up visit, approximately six to eight weeks after their discharge and approximately six months after discharge, the mRS will be assessed by: - their treating physi

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Diagnosis of an aneurysmal subarachnoid hemorrhage according to treating neurologist or neurosurgeon. - Age = 18 years.

Exclusion criteria

Exclusion criteria: - Subjects that died during hospital admission or before the first follow-up measure. - Unclear diagnosis. - Patients who are not able to visit the outpatient clinic for their regular follow-up visit. - Patients who do not speak the Dutch language.

Design outcomes

Primary

MeasureTime frame
1) the inter-rater variability in outcome assessment using the mRS with different assessment methods (assessment by physician, assessment by a structured interview or self-assessment) for adult patients with an aSAH

Secondary

MeasureTime frame
1) An exploration of the causes of possible differences in the inter-rater variability by comparing the physicians score with the answers on the completed structured interview and identify possible determinants for the difference. 2) An exploration whether the mRS can be substituted by a self-assessed mRS. Therefore feasibility questions are evaluated. 3) The correlation between the mRS and different PROMs (i.e. EQ-5D-5L, RAND-36, SS-QoL)

Contacts

Public ContactEdith Nobels-Janssen

Radboud University Medical Center

edith.janssen@radboudumc.nl0031243615085 (secretary)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)