Development and Validation of an ADL-score Based on FIM and EBI (EVA)

Entwicklung Und Validierung Eines ADL-Scores (Activities of Daily Life) Auf Basis Von FIM (Functional Independence Measure) Und EBI (Erweiterter Barthel-Index)

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

Study Overview

• Status: Completed
• Conditions: Neurologic Disorder; Observational Study; Assessment; Functional Independence; ICF; Medical Rehabilitation
• Intervention / Treatment: Behavioral: neurologic rehabilitation

• Study Type: Observational
• Enrollment (Actual): 265

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with neurologic disorders in in-patient rehabilitation

Description

Inclusion Criteria:

• Admission to in-patient neurologic rehabilitation clinic

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Martin Brünger
• Collaborators: Association nationale pour le développement de la qualité dans les hôpitaux et les cliniques (ANQ), Bern, Switzerland
• Investigators: Study Director: Karla Spyra, Prof. Dr., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): February 24, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (ACTUAL): July 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: ANQ-FIM-EBI; U1111-1223-6650 (OTHER: World Health Organization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No