Analysis of Frailty Syndrome Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)
- Conditions
- Frailty Syndrome
- Interventions
- Behavioral: Prehabilitation- new form of care
- Registration Number
- NCT04880824
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1640
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PG cohort Prehabilitation- new form of care 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.
- Primary Outcome Measures
Name Time Method Frailty Up to 1 year Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)
Neuro-cognitive disorder (NCD) Up to 1 year Frequency of neuro-cognitive disorder (mild / major NCD)
- Secondary Outcome Measures
Name Time Method Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) During the hospital stay, an expected average of 1 week 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.
Confusion Assessment Method Severity-Score (CAM-S Long Form) in English During the hospital stay, an expected average of 1 week The Confusion Assessment Method Severity-Score (CAM-S Long Form) is an 10-item delirium screening instrument (range: 0-19 points, 19 = most severe).
Ethical aspects Up to 1 year Wishes of the patient about the intensity of therapy and therapy goals are measured with a questionnaire.
Findings of Memory consultation Up to 1 year During memory consultation cognitive diagnostic findings are measured.
Neuroimaging Up to 1 year 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.
Demand of health services Up to 1 year The need of treatment for curing an illness.
Sarcopenia Up to 1 year 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.
Quality of life Up to 1 year Quality of life is measured by Care Related Quality of Life (CarerQoL)
Cholinesterases 1 Up to 1 year Acetylcholinesterase and Butyrylcholinesterase are measured from liquor
Delirium Rating Scale Revised 98 in English (DRS-R-98) During the hospital stay, an expected average of 1 week 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.
Delirium Severity Scale (CAM-ICU-7) in English During the hospital stay, an expected average of 1 week 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.
Number of Participants with Delirium as Determined by Chart Review During the hospital stay, an expected average of 1 week Delirium is identified chart-based.
Cardiovascular function 2 Up to 1 year Cardiovascular function is measured by cardiovascular complications.
Incidence of delirium During the hospital stay, an expected average of 1 week 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.
Nursing Delirium Screening Scale (Nu-DESC) During the hospital stay, an expected average of 1 week Nursing Delirium Screening Scale (Nu-DESC) score of ≥ 2 is indicative of delirium, range: 0-10 points, 10 = most severe.
Cardiovascular function 1 Up to 1 year Cardiovascular function is measured by Transesophageal Echocardiography.
Patient-related outcome measures (PROMS) Up to 1 year Different tools and questionnaires are combined to measure Patient-related outcome.
Incidence of cognitive impairment Up to 1 year incidence of cognitive impairment is measured by a validated score.
Severity of delirium During the hospital stay, an expected average of 1 week 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.
Confusion Assessment Method (CAM) During the hospital stay, an expected average of 1 week 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.
Intensive Care Delirium Screening Checklist (ICDSC) During the hospital stay, an expected average of 1 week The ICDSC is an 8-item delirium screening instrument (range: 0-8 points). The score is indicative of delirium, if the item is \> 3.
Patient-related experience measures (PREMS) Up to 1 year Patient-reported experiences of health care are measured with a questionnaire.
Incidence of dementia Up to 1 year incidence of dementia is measured by MOCA
Calf circumference Up to 1 year Calf circumference is measured in a standardized position and documented in centimeter.
Arm circumference Up to 1 year Arm circumference is measured in a standardized position and documented in centimeter.
Number of participants with changes in laboratory values 2 Up to 1 year 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.
APOE polymorphisms Up to 1 year APOE polymorphisms are measured from whole blood once during hospital stay, an expected average of one week.
Total interleukin-8 Up to 1 year Total interleukin-8 is measured from whole blood
Delirium days During the hospital stay, an expected average of 1 week The duration of delirium is measured in days.
COVID-19 Up to 1 year SARS-CoV-2 infection
Patient satisfaction Up to 1 year Patient satisfaction score is measured with a likert scale (0 - 10)
Insomnia Up to 1 year Insomnia is measured by Insomnia Severity Index (ISI), which ranges from 0- 21 points
Dental status Up to 1 year (number of teeth, Oral Health Assessment Tool (OHAT), Geriatric Oral Health Assessment Index (GO-HAI), questions regarding prothesis, dentist visits and dental care)
Stress Up to 1 year Stress is measured by Perceived Stress Questionnaire (PSQ20), which ranges from 20-80 points
Anxiety 1 Up to 1 year Anxiety is measured by Generalized Anxiety Disorder 7, points range from 0-21
Anxiety 2 Up to 1 year Anxiety 2 is measured by Faces Anxiety Scale, a valid single-item for self-report measure of state
Nutritional Status Up to 1 year Changes in the nutritional status after elective surgery
Number of participants with changes in laboratory values 1 Up to 1 year 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.
Autophagy of platelets Up to 1 year Autophagy of platelets is measured from whole blood.
Biomarker panel Up to 1 year Biomarker are measured from serum by metabolomic analyses to characterize the frailty complex.
Vitamin D (cholecalciferol) Up to 1 year Vitamin D is measured from whole blood
Analysis of urine Up to 1 year Relative frequency of metabolites is measured in urine
Hip Osteoarthritis Outcome Up to 1 year Hip Osteoarthritis Outcome is measured from Hip disability and Osteoarthritis Outcome Score (HOOS) in orthopedic patients from PG cohort
Skill management Up to 1 year Multiprofessional skill management is evaluated in all participating occupations of the GB cohort in qualitative interviews.
Electroencephalography band power During the hospital stay, an expected average of 1 week 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
Adverse events Up to 1 year Adverse events are measured in all participants, who receive study measurements
Adherence to Mediterranean diet (MD) Up to 1 year 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.
Psychometric properties of the Meta Memory questionnaire During the hospital stay, at the beginning of the investigation, an average of two hours. Psychometric properties of the Meta Memory questionnaire are measured twice before surgery.
Postoperative complications Up to 30 days Complications are measured according to the Clavien-Dindo classification
Cholinesterases 2 Up to 1 year Acetylcholinesterase and Butyrylcholinesterase are measured from whole blood
Intracellular pH Up to 1 year Intracellular pH is measured from whole blood.
Multiplex gene expression analyzes (neuroinflammation and micro RNA panels) Up to 1 year Multiplex gene expression analyzes (neuroinflammation and micro RNA panels) are measured from whole blood
Autoantibodies Up to 1 year Autoantibodies against beta2-adrenergic receptor, muscarinic acetylcholine receptor (M3 / M4), serotonin receptor, dopamine receptor are measured from serum
Trypotophan metabolites and short-chain fatty acids Up to 1 year Trypotophan metabolites and short-chain fatty acids are measured from serum with metabolomic analysis
Peripheral Blood Mononuclear Cell Up to 1 year Peripheral Blood Mononuclear Cell are measured from whole blood.
Protein panel Up to 1 year Proteins are measured from plasma by proteome analysis.
Serum albumin Up to 1 year Serum albumin is measured from whole blood
Sciatica Bothersomeness Index Up to 1 year 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.
Depth of anesthesia During surgery, an expected average of 2 hours Depth of anesthesia is measured by brainwaves in different patient states which range from awake, sedated, unresponsive, surgically anesthetized to deeply anesthetized.
Cytokines Up to 1 year Cytokines (IFN-Ɣ IL-1β IL-4 IL-6 IL-10 IL-17A IL-17E IL-17F IL-21 IL-23 TGF-β1) are measured from plasma
Chemokines Up to 1 year 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
Markers immune-brain axis and gut-brain axis Up to 1 year 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
Analysis of microbiome Up to 1 year Microbial diversity is measured from blood, urine and feces (e.g. Shannon index)
Gait analysis 1 Up to 1 year Temporal (e.g.: total activity duration, stance time) parameters are measured in orthopedic patients from PG cohort.
Gait analysis 2 Up to 1 year Kinetic parameters (e.g.: vertical plantar loading, loading symmetry) are measured in orthopedic patients from PG cohort.
Clinical investigation Up to 1 year 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
Oswestry disability index (ODI) Up to 1 year ODI is measured in patients from PG and NFC cohorts who undergo elective spine surgery and in control patients from NO cohort.
Microbiome 1 Up to 1 year Analyzes of bacteria-specific 16S DNA from different biomaterial.
Microbiome 2 Up to 1 year Analyzes of sequences of known microorganisms from different biomaterial.
HbA1c Up to 1 year HbA1c is measured from whole blood
Dementia markers Up to 1 year 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
Biobanks samples Up to 1 year Secondary use of the biological samples in particular for research purposes
Range of Motion of the hip/knee Up to 1 year Range of Motion of the hip/knee is measured during orthopedic investigation of PG cohort patients
Hip abduction force (for total hip arthroplasty patients) Up to 1 year Hip abduction force is measured during orthopedic investigation of PG cohort patients
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Up to 1 year 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
Knee Osteoarthritis Outcome Up to 1 year Knee Osteoarthritis Outcome is measured from Knee injury and Osteoarthritis Outcome (KOOS) in orthopedic patients from PG cohort
Knee extension and flexion force measurement (for total knee arthroplasty patients) Up to 1 year Knee extension and flexion force measurement is measured during orthopedic investigation of PG cohort patients
Back pain Up to 1 year 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.
Modified Japanese orthopaedic association scale Up to 1 year 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
ASIA Impairment Scale (AIS) Up to 1 year 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
Leg pain Up to 1 year Leg pain is measured by 100mm visual analog scale in patients (PG, NFC, NO cohorts) with lumbal spine problems.
Acceptance of participatory decision-making Up to 1 year Acceptance of participatory decision-making before and after participating in an SDM conference.
Electroencephalography spectral analysis During the hospital stay, at the beginning of the investigation, an average of one hour. Electroencephalography spectral analysis is measured by brainwaves preoperatively.
Effect of analgesics During the hospital stay, an expected average of 1 week 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.
Trial Locations
- Locations (27)
Praxis Prof. Dr med. Ulrich Schwantes
🇩🇪Schwante, Brandenburg, Germany
Carl-Thiem-Klinikum
🇩🇪Cottbus, Germany
Dominikus-Krankenhaus
🇩🇪Berlin, Germany
Universitätsklinikum Mannheim GmbH
🇩🇪Berlin, Germany
Charité-Universitätsmedizin Berlin, Department of Physical Medicine
🇩🇪Berlin, Germany
Praxis Landgraf
🇩🇪Berlin, Germany
Department of Anesthesiology and Operative Intensive Care Medicine (CBF)
🇩🇪Berlin, Germany
Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine
🇩🇪Berlin, Germany
Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau
🇩🇪Berlin, Germany
Paul Gerhard Diakonie - Martin-Luther-Krankenhaus
🇩🇪Berlin, Germany
Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus
🇩🇪Berlin, Germany
CARITAS Klinik Maria Heimsuchung
🇩🇪Berlin, Germany
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany
Wenckebach-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
Werner Forßmann-Krankenhaus
🇩🇪Eberswalde, Germany
Klinikum Frankfurt Oder GmbH
🇩🇪Frankfurt/Oder, Germany
Asklepios Klinikum Harburg
🇩🇪Harburg, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, 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
Sankt Jospeph Krankenhaus
🇩🇪Berlin, Germany
Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany