Analysis of Frailty Syndrome in Patients

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

This study is trying to better understand frailty syndrome by looking at different aspects of it in patients who are frail, along with a control group of non-frail patients and their family members.

Quick facts

• Study type: Observational
• Enrollment: 1640 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Charite University, Berlin, Germany (Academic / other)
• Locations: 27 sites (Schwante, Brandenburg and 26 other locations)
• Trial ID: NCT04880824 on ClinicalTrials.gov

What this trial studies

This study aims to characterize and phenotype frailty syndrome through a comprehensive observational approach. Participants will include patients with frailty from the PRÄP-GO intervention study, a non-frail surgical control group, and a non-surgical comparison group. The study will evaluate various clinical, psychosocial, and pathophysiological aspects related to frailty. Additionally, relatives of patients may also participate, contributing to a broader understanding of the condition.

Who should consider this trial

Good fit: Ideal candidates include patients aged 70 and older scheduled for elective surgery who do not exhibit frailty syndrome.

Not a fit: Patients with severe cardiac or pulmonary diseases, moribund conditions, or significant neuropsychiatric impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for frailty syndrome, enhancing patient outcomes.

How similar studies have performed: While there have been studies on frailty, this specific approach of detailed characterization within a multimodal intervention framework is relatively novel.

Eligibility criteria

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

Where this trial is running

Schwante, Brandenburg and 26 other locations

• Praxis Prof. Dr med. Ulrich Schwantes — Schwante, Brandenburg, Germany (Recruiting)
• Charité-Universitätsmedizin Berlin, Department of Physical Medicine — Berlin, Germany (Recruiting)
• Praxis Landgraf — Berlin, Germany (Recruiting)
• Department of Anesthesiology and Operative Intensive Care Medicine (CBF) — Berlin, Germany (Recruiting)
• Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine — Berlin, Germany (Recruiting)
• Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau — Berlin, Germany (Not_yet_recruiting)
• Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus — Berlin, Germany (Recruiting)
• Paul Gerhard Diakonie - Martin-Luther-Krankenhaus — Berlin, Germany (Not_yet_recruiting)
• Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH — Berlin, Germany (Recruiting)
• CARITAS Klinik Maria Heimsuchung — Berlin, Germany (Recruiting)
• Dominikus-Krankenhaus — Berlin, Germany (Recruiting)
• Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH — Berlin, Germany (Not_yet_recruiting)
• Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH — Berlin, Germany (Not_yet_recruiting)
• Sankt Jospeph Krankenhaus — Berlin, Germany (Recruiting)
• Unfallkrankenhaus Berlin — Berlin, Germany (Not_yet_recruiting)
• Universitätsklinikum Mannheim GmbH — Berlin, Germany (Not_yet_recruiting)
• Wenckebach-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH — Berlin, Germany (Not_yet_recruiting)
• Carl-Thiem-Klinikum — Cottbus, Germany (Not_yet_recruiting)
• Werner Forßmann-Krankenhaus — Eberswalde, Germany (Not_yet_recruiting)
• Klinikum Frankfurt Oder GmbH — Frankfurt/Oder, Germany (Not_yet_recruiting)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Not_yet_recruiting)
• Asklepios Klinikum Harburg — Harburg, Germany (Not_yet_recruiting)
• Sana Kliniken Sommerfeld — Kremmen, Germany (Recruiting)
• Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck — Lübeck, Germany (Not_yet_recruiting)
• Klinikum der Universität München, LMU Campus Großhadern — München, Germany (Not_yet_recruiting)
• Klinikum rechts der Isar - Technische Universität München — München, Germany (Not_yet_recruiting)
• München Klinik Bogenhausen — München, Germany (Not_yet_recruiting)

Study contacts

• Study coordinator: Claudia Spies, MD, Prof.

Conditions Frailty Syndrome