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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04880824
Other study ID # ANA-PRAEP-GO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 19, 2021
Est. completion date August 31, 2025

Study information

Verified date June 2024
Source Charite University, Berlin, Germany
Contact Claudia Spies, MD, Prof.
Phone +49 30 450 551102
Email claudia.spies@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.)


Recruitment information / eligibility

Status Recruiting
Enrollment 1640
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Prehabilitation- new form of care
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frailty Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail) Up to 1 year
Primary Neuro-cognitive disorder (NCD) Frequency of neuro-cognitive disorder (mild / major NCD) Up to 1 year
Secondary Incidence of delirium Incidence of delirium, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Richmond Agitation Scale (RASS), Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), along with the delirium severity scores Confusion Assessment Method Severity-Score (CAM-S) in English, Intensive Care Delirium Screening Checklist (ICDSC), Delirium Rating Scale Revised 98 (DRS-R-98) in English and patient chart review. The assessment period is from the recovery room up to five postoperative days or until hospital discharge. During the hospital stay, an expected average of 1 week
Secondary Severity of delirium Severity of delirium defined as a composite score based on: Confusion Assessment Method Severity-Score(CAM-S); Confusion Assessment Method (CAM), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Delirium Rating Scale Revised (DSR-R-98) in English, Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC) and patient chart review. During the hospital stay, an expected average of 1 week
Secondary Nursing Delirium Screening Scale (Nu-DESC) Nursing Delirium Screening Scale (Nu-DESC) score of = 2 is indicative of delirium, range: 0-10 points, 10 = most severe. During the hospital stay, an expected average of 1 week
Secondary Confusion Assessment Method (CAM) Confusion Assessment Method (CAM) score is indicative of delirium, if the items 1 and 2 and 3 or the items 1 and 2 and 4 are measured positively. During the hospital stay, an expected average of 1 week
Secondary Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score is indicative of delirium, if the items 1 and 2 and 3 or the items 1 and 2 and 4 are measured positively. During the hospital stay, an expected average of 1 week
Secondary Confusion Assessment Method Severity-Score (CAM-S Long Form) in English The Confusion Assessment Method Severity-Score (CAM-S Long Form) is an 10-item delirium screening instrument (range: 0-19 points, 19 = most severe). During the hospital stay, an expected average of 1 week
Secondary Intensive Care Delirium Screening Checklist (ICDSC) The ICDSC is an 8-item delirium screening instrument (range: 0-8 points). The score is indicative of delirium, if the item is > 3. During the hospital stay, an expected average of 1 week
Secondary Delirium Rating Scale Revised 98 in English (DRS-R-98) The delirium rating scale revised 98 is a delirium screening instrument (range 0-46). The score is indicative of delirium, if the item is > 14.5. During the hospital stay, an expected average of 1 week
Secondary Delirium Severity Scale (CAM-ICU-7) in English A 7-point rating scale (0-7) was derived from the CAM-ICU and RASS assessments 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. During the hospital stay, an expected average of 1 week
Secondary Number of Participants with Delirium as Determined by Chart Review Delirium is identified chart-based. During the hospital stay, an expected average of 1 week
Secondary Delirium days The duration of delirium is measured in days. During the hospital stay, an expected average of 1 week
Secondary COVID-19 SARS-CoV-2 infection Up to 1 year
Secondary Cardiovascular function 1 Cardiovascular function is measured by Transesophageal Echocardiography. Up to 1 year
Secondary Cardiovascular function 2 Cardiovascular function is measured by cardiovascular complications. Up to 1 year
Secondary Ethical aspects Wishes of the patient about the intensity of therapy and therapy goals are measured with a questionnaire. Up to 1 year
Secondary Patient satisfaction Patient satisfaction score is measured with a likert scale (0 - 10) Up to 1 year
Secondary Patient-related outcome measures (PROMS) Different tools and questionnaires are combined to measure Patient-related outcome. Up to 1 year
Secondary Patient-related experience measures (PREMS) Patient-reported experiences of health care are measured with a questionnaire. Up to 1 year
Secondary Incidence of dementia incidence of dementia is measured by MOCA Up to 1 year
Secondary Incidence of cognitive impairment incidence of cognitive impairment is measured by a validated score. Up to 1 year
Secondary Findings of Memory consultation During memory consultation cognitive diagnostic findings are measured. Up to 1 year
Secondary Stress Stress is measured by Perceived Stress Questionnaire (PSQ20), which ranges from 20-80 points Up to 1 year
Secondary Anxiety 1 Anxiety is measured by Generalized Anxiety Disorder 7, points range from 0-21 Up to 1 year
Secondary Anxiety 2 Anxiety 2 is measured by Faces Anxiety Scale, a valid single-item for self-report measure of state Up to 1 year
Secondary Insomnia Insomnia is measured by Insomnia Severity Index (ISI), which ranges from 0- 21 points Up to 1 year
Secondary Neuroimaging Routine neuroimaging results were planned to be documented in the hospital including all techniques to image the nervous system as ultrasound, magnetic resonance imaging, conventional radiography, computed tomography and positron emission tomography. Up to 1 year
Secondary Demand of health services The need of treatment for curing an illness. Up to 1 year
Secondary Adverse events Adverse events are measured in all participants, who receive study measurements Up to 1 year
Secondary Nutritional Status Changes in the nutritional status after elective surgery Up to 1 year
Secondary Adherence to Mediterranean diet (MD) Adherence to Mediterranean diet (MD) is measured with a German Medi-Score, could range from 0 to 9, with higher scores (6-9) indicating greater MD adherence. Up to 1 year
Secondary Sarcopenia The composite outcome measure "Sarcopenia" is defined by the following three criteria: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference and 3) low physical performance (gait speed). Criterion (1) identifies probable sarcopenia, additional documentation of criterion (2) confirms sarcopenia diagnosis, and if all criteria (1), (2) and (3) are met, sarcopenia is considered severe. Up to 1 year
Secondary Calf circumference Calf circumference is measured in a standardized position and documented in centimeter. Up to 1 year
Secondary Arm circumference Arm circumference is measured in a standardized position and documented in centimeter. Up to 1 year
Secondary Dental status (number of teeth, Oral Health Assessment Tool (OHAT), Geriatric Oral Health Assessment Index (GO-HAI), questions regarding prothesis, dentist visits and dental care) Up to 1 year
Secondary Quality of life Quality of life is measured by Care Related Quality of Life (CarerQoL) Up to 1 year
Secondary Postoperative complications Complications are measured according to the Clavien-Dindo classification Up to 30 days
Secondary Psychometric properties of the Meta Memory questionnaire Psychometric properties of the Meta Memory questionnaire are measured twice before surgery. During the hospital stay, at the beginning of the investigation, an average of two hours.
Secondary Number of participants with changes in laboratory values 1 Routine laboratory results were planned to be documented in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count from blood samples. Up to 1 year
Secondary Number of participants with changes in laboratory values 2 Routine laboratory results were planned to be documented from the general practitioner including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count from blood samples. Up to 1 year
Secondary APOE polymorphisms APOE polymorphisms are measured from whole blood once during hospital stay, an expected average of one week. Up to 1 year
Secondary Total interleukin-8 Total interleukin-8 is measured from whole blood Up to 1 year
Secondary Cholinesterases 1 Acetylcholinesterase and Butyrylcholinesterase are measured from liquor Up to 1 year
Secondary Cholinesterases 2 Acetylcholinesterase and Butyrylcholinesterase are measured from whole blood Up to 1 year
Secondary Intracellular pH Intracellular pH is measured from whole blood. Up to 1 year
Secondary Autophagy of platelets Autophagy of platelets is measured from whole blood. Up to 1 year
Secondary Peripheral Blood Mononuclear Cell Peripheral Blood Mononuclear Cell are measured from whole blood. Up to 1 year
Secondary Multiplex gene expression analyzes (neuroinflammation and micro RNA panels) Multiplex gene expression analyzes (neuroinflammation and micro RNA panels) are measured from whole blood Up to 1 year
Secondary Autoantibodies Autoantibodies against beta2-adrenergic receptor, muscarinic acetylcholine receptor (M3 / M4), serotonin receptor, dopamine receptor are measured from serum Up to 1 year
Secondary Trypotophan metabolites and short-chain fatty acids Trypotophan metabolites and short-chain fatty acids are measured from serum with metabolomic analysis Up to 1 year
Secondary Biomarker panel Biomarker are measured from serum by metabolomic analyses to characterize the frailty complex. Up to 1 year
Secondary Cytokines Cytokines (IFN-? IL-1ß IL-4 IL-6 IL-10 IL-17A IL-17E IL-17F IL-21 IL-23 TGF-ß1) are measured from plasma Up to 1 year
Secondary Chemokines Chemokines (CCL2 (MCP-1) CCL3 CCL4 CCL5 (RAN-TES) CCL11 (Eotaxin) CCL19 CCL20 CXCL1 CXCL8 (IL-8) CXCL10 (IP-10) CXCL12 (SDF1A) are measured from plasma Up to 1 year
Secondary Markers immune-brain axis and gut-brain axis Markers immune-brain axis and gut-brain axis (zonulin, endothelial cell-specific molecule 1, S100A6, S100A8, S100A9, S100P, S100beta, Interleu-kin-16, CD162, BDNF, CD272, p-selectin, be-ta2microglobulin , Haptoglobin, cathelicidin, NCAM-1, BTLA and CXCR5) are measured from plasma Up to 1 year
Secondary Protein panel Proteins are measured from plasma by proteome analysis. Up to 1 year
Secondary Microbiome 1 Analyzes of bacteria-specific 16S DNA from different biomaterial. Up to 1 year
Secondary Microbiome 2 Analyzes of sequences of known microorganisms from different biomaterial. Up to 1 year
Secondary Serum albumin Serum albumin is measured from whole blood Up to 1 year
Secondary HbA1c HbA1c is measured from whole blood Up to 1 year
Secondary Vitamin D (cholecalciferol) Vitamin D is measured from whole blood Up to 1 year
Secondary Dementia markers Dementia markers: beta amyloid 1-40, beta-amyloid 1-42, beta-amyloid ratio (42/40 * 10), phospho-TAU, protein 14-3-3, PRPSc, TAU (total tau) are measured from liquor Up to 1 year
Secondary Analysis of microbiome Microbial diversity is measured from blood, urine and feces (e.g. Shannon index) Up to 1 year
Secondary Analysis of urine Relative frequency of metabolites is measured in urine Up to 1 year
Secondary Biobanks samples Secondary use of the biological samples in particular for research purposes Up to 1 year
Secondary Hip Osteoarthritis Outcome Hip Osteoarthritis Outcome is measured from Hip disability and Osteoarthritis Outcome Score (HOOS) in orthopedic patients from PG cohort Up to 1 year
Secondary Knee Osteoarthritis Outcome Knee Osteoarthritis Outcome is measured from Knee injury and Osteoarthritis Outcome (KOOS) in orthopedic patients from PG cohort Up to 1 year
Secondary Gait analysis 1 Temporal (e.g.: total activity duration, stance time) parameters are measured in orthopedic patients from PG cohort. Up to 1 year
Secondary Gait analysis 2 Kinetic parameters (e.g.: vertical plantar loading, loading symmetry) are measured in orthopedic patients from PG cohort. Up to 1 year
Secondary Range of Motion of the hip/knee Range of Motion of the hip/knee is measured during orthopedic investigation of PG cohort patients Up to 1 year
Secondary Hip abduction force (for total hip arthroplasty patients) Hip abduction force is measured during orthopedic investigation of PG cohort patients Up to 1 year
Secondary Knee extension and flexion force measurement (for total knee arthroplasty patients) Knee extension and flexion force measurement is measured during orthopedic investigation of PG cohort patients Up to 1 year
Secondary Clinical investigation Clinical investigation is measured by a neurosurgical method in patients from PG and NFC cohorts who undergo elective spine surgery and in control patients from NO cohort Up to 1 year
Secondary Oswestry disability index (ODI) ODI is measured in patients from PG and NFC cohorts who undergo elective spine surgery and in control patients from NO cohort. Up to 1 year
Secondary Back pain Low Back pain is measured by the Roland Morris Low Back pain and disability questionnaire in patients (PG, NFC, NO cohorts) with lumbal spine problems. Up to 1 year
Secondary Leg pain Leg pain is measured by 100mm visual analog scale in patients (PG, NFC, NO cohorts) with lumbal spine problems. Up to 1 year
Secondary Sciatica Bothersomeness Index To establish values for paresthesia, weakness and leg pain the Sciatica Bothersomeness Index is measured n patients (PG, NFC, NO cohorts) with lumbal spine problems. Up to 1 year
Secondary Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) To measure Disabilities of the Arm, Shoulder and Hand the DASH questionnaire is used in patient (PG, NFC, NO cohort) in patients with cervical spine problems Up to 1 year
Secondary Modified Japanese orthopaedic association scale The modified Japanese Orthopaedic Association scale is used to establish criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy in patients (PG, NFC, NO cohorts) with cervical spine problems Up to 1 year
Secondary ASIA Impairment Scale (AIS) ASIA Impairment Scale is used to measure for patients with spinal myelopathies or spinal cord injuries in patients from PG and NFC cohorts who undergo elective spine surgery and in control patients from NO cohort Up to 1 year
Secondary Skill management Multiprofessional skill management is evaluated in all participating occupations of the GB cohort in qualitative interviews. Up to 1 year
Secondary Acceptance of participatory decision-making Acceptance of participatory decision-making before and after participating in an SDM conference. Up to 1 year
Secondary Depth of anesthesia Depth of anesthesia is measured by brainwaves in different patient states which range from awake, sedated, unresponsive, surgically anesthetized to deeply anesthetized. During surgery, an expected average of 2 hours
Secondary Electroencephalography spectral analysis Electroencephalography spectral analysis is measured by brainwaves preoperatively. During the hospital stay, at the beginning of the investigation, an average of one hour.
Secondary Electroencephalography band power Electroencephalography band power is measured postoperatively by an electroencephalography monitor at postoperative day 3 in all patients and in patients with delirium until 48 hours without positive delirium screening During the hospital stay, an expected average of 1 week
Secondary Effect of analgesics Pain is evaluated with the Dolosys Paintracker. The Paintracker is a handy monitoring device to determine the analgesia needed for patients based on the pain reflex technique. During the hospital stay, an expected average of 1 week
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