Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty

NCT ID: NCT04190329

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2020-07-20

Brief Summary

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The aim of the prospective study is to assess the feasibility of a screening and baseline measurement protocol that is planned for a main study (PRÄP-GO) in a collective of 30 patients ageing 70+ scheduled for elective surgery. Comprehensive geriatric assessment scores and modified Fried frailty phenotype component evaluation are performed in all patients at baseline before elective surgery. The assessment of cognitive tests is conducted with a battery of neuropsychological tests, computer-based tests from the Cambridge Neuropsychological Test Automated Battery \[CANTAB®\] and non-computer based tests. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status. 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty should be analyzed in this study and receive further comprehensive geriatric assessment testing up to seven days after surgery/discharge (before 7 postoperative days).

Detailed Description

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Conditions

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Frailty Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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10 non-frail (robust) study patients

Patients fulfill 0 criteria according to modified Fried frailty score.

No interventions assigned to this group

10 pre-frail study patients

Patients fulfill 1-2 criteria criteria according to modified Fried frailty score.

No interventions assigned to this group

10 frail study patients

Patients fulfill 3, 4 or 5 criteria according to modified Fried frailty score.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 70 years
* Male and female patients
* Patient eligible for inclusion: by the patient, preoperatively
* elective surgery
* Expected anesthesia duration\> 60min

Exclusion Criteria

* Severe cardiological or pulmonary disease (NYHA IV, Gold IV)
* Intracranial interventions
* Moribund patients (palliative situation)
* Not enough language skills
* Non-consenting patients
* Participation in another prospective intervention study for study inclusion or throughout the study period.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia Spies

Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Spies, MD Prof.

Role: STUDY_DIRECTOR

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité Univerisitätsmedizin Berlin

Locations

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Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Frailty-Testing

Identifier Type: -

Identifier Source: org_study_id

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