Frailty SyndromeNCT04880824
Analysis of Frailty Syndrome Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)
An observational study of Frailty Syndrome, run by Charite University, Berlin, Germany at 27 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty Syndrome
- What is being tested?
- Prehabilitation- new form of care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 693 participants
- Where
- 27 sitesGermany
- Study dates
- 19 May 2021to 21 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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
Who may be able to join
- 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
- 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
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- No frailty syndrome (0 positive out of 5 standardized parameters) according to the physical frailty phenotype (Fried et al., 2001)
- Age ≥ 70 years
- No elective surgery planned
- No surgery within 6 months prior to study enrollment
- Doctor, nurse or therapist from the cooperation partners of PRAEP-GO who were involved in the project
- Member of a patient in the PRÄP-GO cohort
- Age ≥ 18 years
Who cannot join
- None
- NFC cohort:
- 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
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- 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:
- GB cohort:
- Language barrier
- Relatives:
- Language barrier
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Germany27 sites
Charité-Universitätsmedizin Berlin, Department of Physical Medicine
Berlin, 10117
Praxis Landgraf
Berlin, 12163
Department of Anesthesiology and Operative Intensive Care Medicine (CBF)
Berlin, 12203
Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine
Berlin, 13353
Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau
Berlin, 13589
Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus
Berlin, 14129
Paul Gerhard Diakonie - Martin-Luther-Krankenhaus
Berlin, 14193
Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin
CARITAS Klinik Maria Heimsuchung
Berlin
Dominikus-Krankenhaus
Berlin
Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin
Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
Berlin
Sankt Jospeph Krankenhaus
Berlin
Unfallkrankenhaus Berlin
Berlin
Universitätsklinikum Mannheim GmbH
Berlin
Wenckebach-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin
Carl-Thiem-Klinikum
Cottbus
Werner Forßmann-Krankenhaus
Eberswalde
Klinikum Frankfurt Oder GmbH
Frankfurt (Oder)
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Asklepios Klinikum Harburg
Harburg
Sana Kliniken Sommerfeld
Kremmen
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck
Lübeck
Klinikum der Universität München, LMU Campus Großhadern
München
Klinikum rechts der Isar - Technische Universität München
München
München Klinik Bogenhausen
München
Praxis Prof. Dr med. Ulrich Schwantes
Schwante, Brandenburg, 16727
About this study
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)
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.
Read the 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.)
- Conditions
- Frailty Syndrome
- Being tested
- Prehabilitation- new form of care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation- new form of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)
Measured: Up to 1 year
Neuro-cognitive disorder (NCD)
Frequency of neuro-cognitive disorder (mild / major NCD)
Measured: Up to 1 year
Secondary outcomes (84)
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.
Measured: During the hospital stay, an expected average of 1 week
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.
Measured: During the hospital stay, an expected average of 1 week
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.
Measured: During the hospital stay, an expected average of 1 week
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.
Measured: During the hospital stay, an expected average of 1 week
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.
Measured: During the hospital stay, an expected average of 1 week
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).
Measured: During the hospital stay, an expected average of 1 week
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.
Measured: During the hospital stay, an expected average of 1 week
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.
Measured: During the hospital stay, an expected average of 1 week
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.
Measured: During the hospital stay, an expected average of 1 week
Number of Participants with Delirium as Determined by Chart Review
Delirium is identified chart-based.
Measured: During the hospital stay, an expected average of 1 week
Delirium days
The duration of delirium is measured in days.
Measured: During the hospital stay, an expected average of 1 week
COVID-19
SARS-CoV-2 infection
Measured: Up to 1 year
Cardiovascular function 1
Cardiovascular function is measured by Transesophageal Echocardiography.
Measured: Up to 1 year
Cardiovascular function 2
Cardiovascular function is measured by cardiovascular complications.
Measured: Up to 1 year
Ethical aspects
Wishes of the patient about the intensity of therapy and therapy goals are measured with a questionnaire.
Measured: Up to 1 year
Patient satisfaction
Patient satisfaction score is measured with a likert scale (0 - 10)
Measured: Up to 1 year
Patient-related outcome measures (PROMS)
Different tools and questionnaires are combined to measure Patient-related outcome.
Measured: Up to 1 year
Patient-related experience measures (PREMS)
Patient-reported experiences of health care are measured with a questionnaire.
Measured: Up to 1 year
Incidence of dementia
incidence of dementia is measured by MOCA
Measured: Up to 1 year
Incidence of cognitive impairment
incidence of cognitive impairment is measured by a validated score.
Measured: Up to 1 year
Findings of Memory consultation
During memory consultation cognitive diagnostic findings are measured.
Measured: Up to 1 year
Stress
Stress is measured by Perceived Stress Questionnaire (PSQ20), which ranges from 20-80 points
Measured: Up to 1 year
Anxiety 1
Anxiety is measured by Generalized Anxiety Disorder 7, points range from 0-21
Measured: Up to 1 year
Anxiety 2
Anxiety 2 is measured by Faces Anxiety Scale, a valid single-item for self-report measure of state
Measured: Up to 1 year
Insomnia
Insomnia is measured by Insomnia Severity Index (ISI), which ranges from 0- 21 points
Measured: Up to 1 year
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.
Measured: Up to 1 year
Demand of health services
The need of treatment for curing an illness.
Measured: Up to 1 year
Adverse events
Adverse events are measured in all participants, who receive study measurements
Measured: Up to 1 year
Nutritional Status
Changes in the nutritional status after elective surgery
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
Calf circumference
Calf circumference is measured in a standardized position and documented in centimeter.
Measured: Up to 1 year
Arm circumference
Arm circumference is measured in a standardized position and documented in centimeter.
Measured: Up to 1 year
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)
Measured: Up to 1 year
Quality of life
Quality of life is measured by Care Related Quality of Life (CarerQoL)
Measured: Up to 1 year
Postoperative complications
Complications are measured according to the Clavien-Dindo classification
Measured: Up to 30 days
Psychometric properties of the Meta Memory questionnaire
Psychometric properties of the Meta Memory questionnaire are measured twice before surgery.
Measured: During the hospital stay, at the beginning of the investigation, an average of two hours.
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
APOE polymorphisms
APOE polymorphisms are measured from whole blood once during hospital stay, an expected average of one week.
Measured: Up to 1 year
Total interleukin-8
Total interleukin-8 is measured from whole blood
Measured: Up to 1 year
Cholinesterases 1
Acetylcholinesterase and Butyrylcholinesterase are measured from liquor
Measured: Up to 1 year
Cholinesterases 2
Acetylcholinesterase and Butyrylcholinesterase are measured from whole blood
Measured: Up to 1 year
Intracellular pH
Intracellular pH is measured from whole blood.
Measured: Up to 1 year
Autophagy of platelets
Autophagy of platelets is measured from whole blood.
Measured: Up to 1 year
Peripheral Blood Mononuclear Cell
Peripheral Blood Mononuclear Cell are measured from whole blood.
Measured: Up to 1 year
Multiplex gene expression analyzes (neuroinflammation and micro RNA panels)
Multiplex gene expression analyzes (neuroinflammation and micro RNA panels) are measured from whole blood
Measured: Up to 1 year
Autoantibodies
Autoantibodies against beta2-adrenergic receptor, muscarinic acetylcholine receptor (M3 / M4), serotonin receptor, dopamine receptor are measured from serum
Measured: Up to 1 year
Trypotophan metabolites and short-chain fatty acids
Trypotophan metabolites and short-chain fatty acids are measured from serum with metabolomic analysis
Measured: Up to 1 year
Biomarker panel
Biomarker are measured from serum by metabolomic analyses to characterize the frailty complex.
Measured: Up to 1 year
Cytokines
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
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 year
Protein panel
Proteins are measured from plasma by proteome analysis.
Measured: Up to 1 year
Microbiome 1
Analyzes of bacteria-specific 16S DNA from different biomaterial.
Measured: Up to 1 year
Microbiome 2
Analyzes of sequences of known microorganisms from different biomaterial.
Measured: Up to 1 year
Serum albumin
Serum albumin is measured from whole blood
Measured: Up to 1 year
HbA1c
HbA1c is measured from whole blood
Measured: Up to 1 year
Vitamin D (cholecalciferol)
Vitamin D is measured from whole blood
Measured: Up to 1 year
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
Measured: Up to 1 year
Analysis of microbiome
Microbial diversity is measured from blood, urine and feces (e.g. Shannon index)
Measured: Up to 1 year
Analysis of urine
Relative frequency of metabolites is measured in urine
Measured: Up to 1 year
Biobanks samples
Secondary use of the biological samples in particular for research purposes
Measured: Up to 1 year
Hip Osteoarthritis Outcome
Hip Osteoarthritis Outcome is measured from Hip disability and Osteoarthritis Outcome Score (HOOS) in orthopedic patients from PG cohort
Measured: Up to 1 year
Knee Osteoarthritis Outcome
Knee Osteoarthritis Outcome is measured from Knee injury and Osteoarthritis Outcome (KOOS) in orthopedic patients from PG cohort
Measured: Up to 1 year
Gait analysis 1
Temporal (e.g.: total activity duration, stance time) parameters are measured in orthopedic patients from PG cohort.
Measured: Up to 1 year
Gait analysis 2
Kinetic parameters (e.g.: vertical plantar loading, loading symmetry) are measured in orthopedic patients from PG cohort.
Measured: Up to 1 year
Range of Motion of the hip/knee
Range of Motion of the hip/knee is measured during orthopedic investigation of PG cohort patients
Measured: Up to 1 year
Hip abduction force (for total hip arthroplasty patients)
Hip abduction force is measured during orthopedic investigation of PG cohort patients
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
Leg pain
Leg pain is measured by 100mm visual analog scale in patients (PG, NFC, NO cohorts) with lumbal spine problems.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 year
Skill management
Multiprofessional skill management is evaluated in all participating occupations of the GB cohort in qualitative interviews.
Measured: Up to 1 year
Acceptance of participatory decision-making
Acceptance of participatory decision-making before and after participating in an SDM conference.
Measured: Up to 1 year
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.
Measured: During surgery, an expected average of 2 hours
Electroencephalography spectral analysis
Electroencephalography spectral analysis is measured by brainwaves preoperatively.
Measured: During the hospital stay, at the beginning of the investigation, an average of one hour.
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
Measured: During the hospital stay, an expected average of 1 week
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.
Measured: During the hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start19 May 2021
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880824
- Sponsor's protocol ID
- ANA-PRAEP-GO
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2021
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04880824
- Acronym / sponsor ID
- ANA-PRAEP-GO
- Conditions
- Frailty Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PG cohort | – | Behavioral: Prehabilitation- new form of care800 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. |
| 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (13 listed)
- 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
- 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
Key exclusion criteria (13 listed)
- None
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation- new form of careThe 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. | Behavioural | PG cohort |
Primary outcome
Frailty
Time frame: 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)
Time frame: Up to 1 year
Frequency of neuro-cognitive disorder (mild / major NCD)
84 secondary outcomes
Incidence of delirium
Time frame: During the hospital stay, an expected average of 1 week
Severity of delirium
Time frame: During the hospital stay, an expected average of 1 week
Nursing Delirium Screening Scale (Nu-DESC)
Time frame: During the hospital stay, an expected average of 1 week
Confusion Assessment Method (CAM)
Time frame: During the hospital stay, an expected average of 1 week
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Time frame: During the hospital stay, an expected average of 1 week
Confusion Assessment Method Severity-Score (CAM-S Long Form) in English
Time frame: During the hospital stay, an expected average of 1 week
Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: During the hospital stay, an expected average of 1 week
Delirium Rating Scale Revised 98 in English (DRS-R-98)
Time frame: During the hospital stay, an expected average of 1 week
Delirium Severity Scale (CAM-ICU-7) in English
Time frame: During the hospital stay, an expected average of 1 week
Number of Participants with Delirium as Determined by Chart Review
Time frame: During the hospital stay, an expected average of 1 week
Delirium days
Time frame: During the hospital stay, an expected average of 1 week
COVID-19
Time frame: Up to 1 year
Cardiovascular function 1
Time frame: Up to 1 year
Cardiovascular function 2
Time frame: Up to 1 year
Ethical aspects
Time frame: Up to 1 year
Patient satisfaction
Time frame: Up to 1 year
Patient-related outcome measures (PROMS)
Time frame: Up to 1 year
Patient-related experience measures (PREMS)
Time frame: Up to 1 year
Incidence of dementia
Time frame: Up to 1 year
Incidence of cognitive impairment
Time frame: Up to 1 year
Findings of Memory consultation
Time frame: Up to 1 year
Stress
Time frame: Up to 1 year
Anxiety 1
Time frame: Up to 1 year
Anxiety 2
Time frame: Up to 1 year
Insomnia
Time frame: Up to 1 year
Neuroimaging
Time frame: Up to 1 year
Demand of health services
Time frame: Up to 1 year
Adverse events
Time frame: Up to 1 year
Nutritional Status
Time frame: Up to 1 year
Adherence to Mediterranean diet (MD)
Time frame: Up to 1 year
Sarcopenia
Time frame: Up to 1 year
Calf circumference
Time frame: Up to 1 year
Arm circumference
Time frame: Up to 1 year
Dental status
Time frame: Up to 1 year
Quality of life
Time frame: Up to 1 year
Postoperative complications
Time frame: Up to 30 days
Psychometric properties of the Meta Memory questionnaire
Time frame: During the hospital stay, at the beginning of the investigation, an average of two hours.
Number of participants with changes in laboratory values 1
Time frame: Up to 1 year
Number of participants with changes in laboratory values 2
Time frame: Up to 1 year
APOE polymorphisms
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty Syndrome, run by Charite University, Berlin, Germany at 27 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.