Clinical trial NCT04880824: Analysis of Frailty Syndrome Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 1640
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 evaluating clinical issues only. In order to be able to research further pathophysiological, clinical, psychosocial and work-organizational connections, different groups of participants will be offered the participation in this scientific support program of PRÄP-GO.

The groups of participants in this 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)

Additionally, relatives of the patients can be included.

Subprojects are included to reflect research questions of interest in sub groups:

* Success of endoprosthetic implants (clinical outcome and gait pattern after total hip arthroplasty and total knee arthroplasty in frail patients)
* Functional treatment outcome and health-related quality of life after elective spinal surgery in the PG cohort, in the NFC cohort, and in the NO cohort
* Hemodynamic evaluation in patients of the PG and NFC cohort with preoperative abnormal cardiovascular function
* Establishment of a German standard database for 14 CANTAB tests by CANTAB Connect technology
* Aggregated evaluation of the cognitive data of different surgical cohorts from studies carried out at the department of anesthesiology to describe domain-specific changes in the perioperative course
* Perspectives of different health professional groups regarding barriers and facilitators in the implementation of a prehabilitation program and necessary changes in skill, organizational and management, and communication in an interdisciplinary setting
* Perspectives of patients and significant others regarding the organizational pathway of the prehabilitation program
* Frequency, pathophysiology and trajectory of muscle weakness as well as functional impairments of patients admitted to intensive care units of the PG and NFC cohort and their long-term outcomes.
* The gut microbiome as a potential risk factor for perioperative neurocognitive disorders (PNDs) in the elderly
* Evaluation of nutrition data in all cohorts (e.g. adherence to mediterranean diet, nutrition habits, nutritional status, dental status etc.)

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

Primary outcomes:
measure: Frailty
timeFrame: Up to 1 year
measure: Neuro-cognitive disorder (NCD)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Incidence of delirium
timeFrame: During the hospital stay, an expected average of 1 week
measure: Severity of delirium
timeFrame: During the hospital stay, an expected average of 1 week
measure: Nursing Delirium Screening Scale (Nu-DESC)
timeFrame: During the hospital stay, an expected average of 1 week
measure: Confusion Assessment Method (CAM)
timeFrame: During the hospital stay, an expected average of 1 week
measure: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
timeFrame: During the hospital stay, an expected average of 1 week
measure: Confusion Assessment Method Severity-Score (CAM-S Long Form) in English
timeFrame: During the hospital stay, an expected average of 1 week
measure: Intensive Care Delirium Screening Checklist (ICDSC)
timeFrame: During the hospital stay, an expected average of 1 week
measure: Delirium Rating Scale Revised 98 in English (DRS-R-98)
timeFrame: During the hospital stay, an expected average of 1 week
measure: Delirium Severity Scale (CAM-ICU-7) in English
timeFrame: During the hospital stay, an expected average of 1 week
measure: Number of Participants with Delirium as Determined by Chart Review
timeFrame: During the hospital stay, an expected average of 1 week
measure: Delirium days
timeFrame: During the hospital stay, an expected average of 1 week
measure: COVID-19
timeFrame: Up to 1 year
measure: Cardiovascular function 1
timeFrame: Up to 1 year
measure: Cardiovascular function 2
timeFrame: Up to 1 year
measure: Ethical aspects
timeFrame: Up to 1 year
measure: Patient satisfaction
timeFrame: Up to 1 year
measure: Patient-related outcome measures (PROMS)
timeFrame: Up to 1 year
measure: Patient-related experience measures (PREMS)
timeFrame: Up to 1 year
measure: Incidence of dementia
timeFrame: Up to 1 year
measure: Incidence of cognitive impairment
timeFrame: Up to 1 year
measure: Findings of Memory consultation
timeFrame: Up to 1 year
measure: Stress
timeFrame: Up to 1 year
measure: Anxiety 1
timeFrame: Up to 1 year
measure: Anxiety 2
timeFrame: Up to 1 year
measure: Insomnia
timeFrame: Up to 1 year
measure: Neuroimaging
timeFrame: Up to 1 year
measure: Demand of health services
timeFrame: Up to 1 year
measure: Adverse events
timeFrame: Up to 1 year
measure: Nutritional Status
timeFrame: Up to 1 year
measure: Adherence to Mediterranean diet (MD)
timeFrame: Up to 1 year
measure: Sarcopenia
timeFrame: Up to 1 year
measure: Calf circumference
timeFrame: Up to 1 year
measure: Arm circumference
timeFrame: Up to 1 year
measure: Dental status
timeFrame: Up to 1 year
measure: Quality of life
timeFrame: Up to 1 year
measure: Postoperative complications
timeFrame: Up to 30 days
measure: Psychometric properties of the Meta Memory questionnaire
timeFrame: During the hospital stay, at the beginning of the investigation, an average of two hours.
measure: Number of participants with changes in laboratory values 1
timeFrame: Up to 1 year
measure: Number of participants with changes in laboratory values 2
timeFrame: Up to 1 year
measure: APOE polymorphisms
timeFrame: Up to 1 year
measure: Total interleukin-8
timeFrame: Up to 1 year
measure: Cholinesterases 1
timeFrame: Up to 1 year
measure: Cholinesterases 2
timeFrame: Up to 1 year
measure: Intracellular pH
timeFrame: Up to 1 year
measure: Autophagy of platelets
timeFrame: Up to 1 year
measure: Peripheral Blood Mononuclear Cell
timeFrame: Up to 1 year
measure: Multiplex gene expression analyzes (neuroinflammation and micro RNA panels)
timeFrame: Up to 1 year
measure: Autoantibodies
timeFrame: Up to 1 year
measure: Trypotophan metabolites and short-chain fatty acids
timeFrame: Up to 1 year
measure: Biomarker panel
timeFrame: Up to 1 year
measure: Cytokines
timeFrame: Up to 1 year
measure: Chemokines
timeFrame: Up to 1 year
measure: Markers immune-brain axis and gut-brain axis
timeFrame: Up to 1 year
measure: Protein panel
timeFrame: Up to 1 year
measure: Microbiome 1
timeFrame: Up to 1 year
measure: Microbiome 2
timeFrame: Up to 1 year
measure: Serum albumin
timeFrame: Up to 1 year
measure: HbA1c
timeFrame: Up to 1 year
measure: Vitamin D (cholecalciferol)
timeFrame: Up to 1 year
measure: Dementia markers
timeFrame: Up to 1 year
measure: Analysis of microbiome
timeFrame: Up to 1 year
measure: Analysis of urine
timeFrame: Up to 1 year
measure: Biobanks samples
timeFrame: Up to 1 year
measure: Hip Osteoarthritis Outcome
timeFrame: Up to 1 year
measure: Knee Osteoarthritis Outcome
timeFrame: Up to 1 year
measure: Gait analysis 1
timeFrame: Up to 1 year
measure: Gait analysis 2
timeFrame: Up to 1 year
measure: Range of Motion of the hip/knee
timeFrame: Up to 1 year
measure: Hip abduction force (for total hip arthroplasty patients)
timeFrame: Up to 1 year
measure: Knee extension and flexion force measurement (for total knee arthroplasty patients)
timeFrame: Up to 1 year
measure: Clinical investigation
timeFrame: Up to 1 year
measure: Oswestry disability index (ODI)
timeFrame: Up to 1 year
measure: Back pain
timeFrame: Up to 1 year
measure: Leg pain
timeFrame: Up to 1 year
measure: Sciatica Bothersomeness Index
timeFrame: Up to 1 year
measure: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
timeFrame: Up to 1 year
measure: Modified Japanese orthopaedic association scale
timeFrame: Up to 1 year
measure: ASIA Impairment Scale (AIS)
timeFrame: Up to 1 year
measure: Skill management
timeFrame: Up to 1 year
measure: Acceptance of participatory decision-making
timeFrame: Up to 1 year
measure: Depth of anesthesia
timeFrame: During surgery, an expected average of 2 hours
measure: Electroencephalography spectral analysis
timeFrame: During the hospital stay, at the beginning of the investigation, an average of one hour.
measure: Electroencephalography band power
timeFrame: During the hospital stay, an expected average of 1 week
measure: Effect of analgesics
timeFrame: During the hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Schwante
country: Germany
facility: Praxis Prof. Dr med. Ulrich Schwantes
state: Brandenburg
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin, Department of Physical Medicine
city: Berlin
country: Germany
facility: Praxis Landgraf
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CBF)
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine
city: Berlin
country: Germany
facility: Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau
city: Berlin
country: Germany
facility: Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus
city: Berlin
country: Germany
facility: Paul Gerhard Diakonie - Martin-Luther-Krankenhaus
city: Berlin
country: Germany
facility: Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: CARITAS Klinik Maria Heimsuchung
city: Berlin
country: Germany
facility: Dominikus-Krankenhaus
city: Berlin
country: Germany
facility: Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Sankt Jospeph Krankenhaus
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Berlin
country: Germany
facility: Universitätsklinikum Mannheim GmbH
city: Berlin
country: Germany
facility: Wenckebach-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum
city: Eberswalde
country: Germany
facility: Werner Forßmann-Krankenhaus
city: Frankfurt/Oder
country: Germany
facility: Klinikum Frankfurt Oder GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Harburg
country: Germany
facility: Asklepios Klinikum Harburg
city: Kremmen
country: Germany
facility: Sana Kliniken Sommerfeld
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck
city: München
country: Germany
facility: Klinikum der Universität München, LMU Campus Großhadern
city: München
country: Germany
facility: Klinikum rechts der Isar - Technische Universität München
city: München
country: Germany
facility: München Klinik Bogenhausen
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: