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Status:

COMPLETED

Analysis of Frailty Syndrome Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)

Lead Sponsor:

Charite University, Berlin, Germany

Conditions:

Frailty Syndrome

Eligibility:

All Genders

70+ years

Brief Summary

The patients included in PRÄP-GO and the corresponding comparison cohorts will be offered to participate in this complementary study in order to be able to carry out a detailed characterization and ph...

Detailed Description

As part of the innovation fund project PRÄP-GO (EA1/225/19), a multimodal intervention is being conducted in patients with a frailty syndrome. However, the health care research project is limited to e...

Eligibility Criteria

Inclusion

  • PG cohort:
  • Inclusion criteria
  • Consent given and inclusion in PRÄP-GO
  • Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent
  • Exclusion criteria
  • \- None
  • NFC cohort:
  • Inclusion criteria
  • Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent
  • Age ≥ 70 years
  • Elective surgery planned
  • Expected anesthesia duration\> 60 min
  • No frailty syndrome (0 positive out of 5 standardized parameters) according to the physical frailty phenotype (Fried et al., 2001)
  • Exclusion criteria
  • Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
  • Intracranial interventions
  • Moribund patients (palliative situation)
  • Patients with a neuropsychiatric clinical picture or severe hearing and / or visual acuity impairment (not compensated by visual or hearing aids), which limit the performance of the neurocognitive tests
  • Insufficient language skills
  • Participation in another interventional rehabilitation study or a study according to the German Drug Law or the medical Device Law that has not been approved by the study leader (Exception: parallel participation in adjuvant therapy study).
  • NO cohort:
  • Inclusion criteria
  • \- Age ≥ 70 years
  • No elective surgery planned
  • No surgery within 6 months prior to study enrollment
  • Exclusion criteria - See NFC cohort
  • GB cohort:
  • Inclusion criterion
  • \- Doctor, nurse or therapist from the cooperation partners of PRAEP-GO who were involved in the project
  • Exclusion criterion
  • \- Language barrier
  • Relatives:
  • Inclusion criteria
  • Member of a patient in the PRÄP-GO cohort
  • Age ≥ 18 years
  • Exclusion criterion
  • \- Language barrier

Exclusion

    Key Trial Info

    Start Date :

    May 19 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 21 2025

    Estimated Enrollment :

    693 Patients enrolled

    Trial Details

    Trial ID

    NCT04880824

    Start Date

    May 19 2021

    End Date

    March 21 2025

    Last Update

    August 26 2025

    Active Locations (27)

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    Page 1 of 7 (27 locations)

    1

    Praxis Prof. Dr med. Ulrich Schwantes

    Schwante, Brandenburg, Germany, 16727

    2

    Charité-Universitätsmedizin Berlin, Department of Physical Medicine

    Berlin, Germany, 10117

    3

    Praxis Landgraf

    Berlin, Germany, 12163

    4

    Department of Anesthesiology and Operative Intensive Care Medicine (CBF)

    Berlin, Germany, 12203