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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03233789
Other study ID # ANQ-FIM-EBI
Secondary ID U1111-1223-6650
Status Completed
Phase
First received
Last updated
Start date November 1, 2015
Est. completion date December 31, 2017

Study information

Verified date January 2019
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation clinics.

The following steps are performed:

1. Development of an ADL-algorithms by experts

2. Validation of the ADL-algorithms in a quantitative approach

3. Finalization of the ADL-algorithms by experts based on study results


Recruitment information / eligibility

Status Completed
Enrollment 265
Est. completion date December 31, 2017
Est. primary completion date February 24, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Admission to in-patient neurologic rehabilitation clinic

Exclusion Criteria:

- No sufficient language skills (German, French or Italian)

Study Design


Intervention

Behavioral:
neurologic rehabilitation
in-patient rehabilitation of neurologic disorders

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Martin Brünger Association nationale pour le développement de la qualité dans les hôpitaux et les cliniques (ANQ), Bern, Switzerland

Outcome

Type Measure Description Time frame Safety issue
Primary Agreement FIM-based ADL-score vs. EBI-based ADL-score Agreement according to Cohens kappa (FIM-based ADL-score vs. EBI-based ADL-score) within 3 days of admission to rehabilitation clinic
Secondary Correlation FIM-based ADL-score vs. EBI-based ADL-score Spearman's correlation (FIM-based ADL-score vs. EBI-based ADL-score) within 3 days of admission to rehabilitation clinic
Secondary Difference in FIM-based ADL-score vs. EBI-based ADL-score Delta in points FIM-based ADL-score vs. EBI-based ADL-score within 3 days of admission to rehabilitation clinic
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