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

NCT04880824 | Completed

• 1 other identifier: ANA-PRAEP-GO
• Study Type: observational
• Target: 693
• Locations: 1 country
• Sites: 27

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 phenotyping of the frailty complex. Amendment vote of 08/05/2024: Recruitment extension of Non-frail surgical control group (NFC cohort) until August 31, 2025.

Conditions

Frailty Syndrome

Outcome Measures

Primary Outcomes (2)

• Frailty

  Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)

  Up to 1 year

• Neuro-cognitive disorder (NCD)

  Frequency of neuro-cognitive disorder (mild / major NCD)

  Up to 1 year

Secondary Outcomes (84)

• Incidence of delirium

  During the hospital stay, an expected average of 1 week

• Severity of delirium

  During the hospital stay, an expected average of 1 week

• Nursing Delirium Screening Scale (Nu-DESC)

  During the hospital stay, an expected average of 1 week

• Confusion Assessment Method (CAM)

  During the hospital stay, an expected average of 1 week

• Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

  During the hospital stay, an expected average of 1 week

Study Arms (4)

PG cohort

800 randomized surgical study patients with a frailty syndrome (Pre-frail and frail) of the intervention study PRÄP-GO (PG cohort). 400 study patients receive the intervention and 400 study patients receive standard of care.

Behavioral: Prehabilitation- new form of care

NFC cohort

400 non-frail surgical control group (NFC cohort)

NO cohort

300 non-operative control group (NO cohort)

GB cohort

Skill-Change-Management: a maximum of 30 coworkers and analysis of guiding principle: to a maximum of 35 patients, 30 relatives and 45 coworkers

Interventions

Prehabilitation- new form of care BEHAVIORAL

The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.

PG cohort

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The groups of participants in this scientific accompanying program ANA-PRÄP-GO are: * Randomized study patients with a frailty syndrome of the intervention study PRÄP-GO (PG cohort) * Non-frail surgical control group (NFC cohort) * Non-surgical comparison group (NO cohort) * Participants with health professions (GB cohort) * Relatives of the included patients

You may qualify if:

• Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent

You may not qualify if:

• \- None
• NFC cohort:
• 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)
• 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:
• \- Age ≥ 70 years

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (27)

Praxis Prof. Dr med. Ulrich Schwantes

Schwante, Brandenburg, 16727, Germany

Location

Charité-Universitätsmedizin Berlin, Department of Physical Medicine

Berlin, 10117, Germany

Location

Praxis Landgraf

Berlin, 12163, Germany

Location

Department of Anesthesiology and Operative Intensive Care Medicine (CBF)

Berlin, 12203, Germany

Location

Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine

Berlin, 13353, Germany

Location

Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus

Berlin, 14129, Germany

Location

Paul Gerhard Diakonie - Martin-Luther-Krankenhaus

Berlin, 14193, Germany

Location

Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, Germany

Location

CARITAS Klinik Maria Heimsuchung

Berlin, Germany

Location

Dominikus-Krankenhaus

Berlin, Germany

Location

Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, Germany

Location

Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, Germany

Location

Sankt Jospeph Krankenhaus

Berlin, Germany

Location

Unfallkrankenhaus Berlin

Berlin, Germany

Location

Universitätsklinikum Mannheim GmbH

Berlin, Germany

Location

Wenckebach-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, Germany

Location

Carl-Thiem-Klinikum

Cottbus, Germany

Location

Werner Forßmann-Krankenhaus

Eberswalde, Germany

Location

Klinikum Frankfurt Oder GmbH

Frankfurt (Oder), Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Asklepios Klinikum Harburg

Harburg, Germany

Location

Sana Kliniken Sommerfeld

Kremmen, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck

Lübeck, Germany

Location

Klinikum der Universität München, LMU Campus Großhadern

München, Germany

Location

Klinikum rechts der Isar - Technische Universität München

München, Germany

Location

München Klinik Bogenhausen

München, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Genetical analyses from blood samples: Multiplex gene expression analyzes (neuroinflammation and micro RNA panels) and APOE polymorphisms

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 11, 2021
• Study Start: May 19, 2021
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (27)