- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04418271
Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)
Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)
The aim of the study is to evaluate the effect of a shared decision-making conference and three-week prehabilitation program on the outcome "care dependency" one year after surgery. The cost-effectiveness of the intervention will also be evaluated in this N = 1400 patient, national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group, clinical trial.
The objective of PRÄP-GO is to establish and employ a suitable preoperative case-care management system to improve the short and long-term outcome of elderly surgical patients with signs of a frailty syndrome, improving postoperative quality of life and reducing care dependency by a three-week individualized prehabilitation program.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claudia Spies, MD, Prof.
- Phone Number: +49 30 450 531012
- Email: claudia.spies@charite.de
Study Locations
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-
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Bad Oeynhausen, Germany
- Recruiting
- Herz- und Diabetes Zentrum
-
Berlin, Germany, 12203
- Recruiting
- Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
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Principal Investigator:
- Sascha Treskatsch, MD, Prof.
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Contact:
- Sascha Treskatsch, MD. Prof.
- Phone Number: +49 30 450 55 15 22
- Email: sascha.treskatsch@charite.de
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Berlin, Germany, 13353
- Recruiting
- Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
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Contact:
- Claudia Spies, MD, Prof.
- Phone Number: +49 30 450 55 10 01
- Email: claudia.spies@charite.de
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Principal Investigator:
- Claudia Spies, MD, Prof.
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Sub-Investigator:
- Stefan Schaller, MD, Prof.
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Sub-Investigator:
- Katrin Schmidt, MD
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Berlin, Germany
- Recruiting
- Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
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Berlin, Germany
- Recruiting
- Bundeswehrkrankenhaus
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Berlin, Germany
- Recruiting
- CARITAS Klinik Maria Heimsuchung
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Berlin, Germany
- Recruiting
- Dominikus-Krankenhaus
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Berlin, Germany
- Recruiting
- Evangelisches Krankenhaus Hubertus
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Berlin, Germany
- Not yet recruiting
- Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
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Berlin, Germany
- Recruiting
- Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
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Berlin, Germany
- Withdrawn
- Martin-Luther-Krankenhaus
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Berlin, Germany
- Recruiting
- Sankt Joseph Krankenhaus
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Berlin, Germany
- Recruiting
- Unfallkrankenhaus Berlin
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Frankfurt/Oder, Germany
- Withdrawn
- Klinikum Frankfurt Oder GmbH
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Greifswald, Germany
- Recruiting
- Universitätsmedizin Greifswald
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Hamburg, Germany
- Recruiting
- Universitätsklinikum Hamburg-Eppendorf
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Kremmen, Germany
- Recruiting
- Sana Kliniken Sommerfeld
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Lübeck, Germany
- Recruiting
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck
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München, Germany
- Recruiting
- Klinikum der Universität München, LMU Campus Großhadern
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München, Germany
- Recruiting
- Klinikum rechts der Isar - Technische Universität München
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München, Germany
- Recruiting
- München Klinik Bogenhausen
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Nauen, Germany, 14641
- Recruiting
- Havelland Kliniken GmbH - Klinik Nauen
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Rathenow, Germany, 14712
- Active, not recruiting
- Havelland Kliniken-Klinik Rathenow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Study patients:
Inclusion Criteria:
- Age ≥ 70 years
- Consent by Patient or Legal Representative
- Elective surgery planned
- Expected anesthesia duration≥ 60 min
- Statutory health insurance
- Frailty syndrome (≥1 positive out of 5 standardized parameters according to the Physical Frailty Phenotype according to Fried et. al.)
Exclusion Criteria:
- Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
- Intracranial interventions
- Moribund patients (palliative situation)
- Not enough language skills
- Participation in another interventional rehabilitation study or other interventional clinical trial that has not been approved by the study management committee (Exception: Participation in adjuvant intervention study)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prehabilitation
Prefrail and frail patients receive 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.
|
No Intervention: Standard of Care
Prefrail and frail patients receive no prehabilitation, but receive standard of care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of care dependency
Time Frame: Up to one year
|
Assessment results in a degree of care dependency from personal help according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008).
The results of the assessments ranges between 0 and 100 points, which are transformed into a 0-5 ordinal scale.
Higher points in the assessments indicate higher demand of care dependency.
Accordingly, higher numbers on the ordinal scale indicate a higher level of care dependency as defined in the German statutory care insurance program.
|
Up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurocognitive Disorder (NCD)
Time Frame: Up to one year
|
New diagnosis of mild/major Neurocognitive Disorder at 3 and 12 months.
The diagnosis is made based on DSM-V criteria including a multi-component cognitive test battery comparing with baseline testing and comparison to a non-surgical observational control group.
|
Up to one year
|
Suspected Neurocognitive disorder by MiniCog
Time Frame: Up to one year
|
Dementia is suspected by limited MiniCog-test result.
The MiniCog consists of two items, the word recall test and the clock-drawing test.
Performance in these test is rated on a scale ranging from 0 - 5, with <3 points indicating a suspicion of dementia.
|
Up to one year
|
Suspected Dementia by MOCA
Time Frame: Up to one year
|
Dementia is suspected by a Montreal Cognitive Assessment (MOCA) according to normative age-adjusted values.
The MOCA consists of 13 items which are rated on a scale between 0 and 30 points.
|
Up to one year
|
Suspected postoperative neurocognitive disorder (POCD)
Time Frame: Up to one year
|
The non-computerized neuropsychological Trail Making Test are used as indicator screening test for relevant cognitive change after surgery.
An increase of >55 seconds in TMT-B test performance at three and/or 12 months after surgery compared to baseline is set as cut off.
|
Up to one year
|
Frailty
Time Frame: Up to one year
|
Frailty is operationalized using modified Fried frailty criteria.
Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status.
|
Up to one year
|
Polypharmacy
Time Frame: Up to one year
|
Measured by number of drug agents
|
Up to one year
|
Alcohol Use
Time Frame: Up to one year
|
Measured by number of drug agents
|
Up to one year
|
Tobacco Use
Time Frame: Up to one year
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Measured by Fagerstrom (Fagerstrom & Schneider, 1989)
|
Up to one year
|
Intraoperative Neuromonitoring
Time Frame: During surgery
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Monitoring of electroencephalography during surgery
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During surgery
|
Result of surgery
Time Frame: Up to one year
|
Incidence of complications (intra- and post-operative)
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Up to one year
|
Autonomy Preference
Time Frame: At the beginning of the observation
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Extent of patients' autonomy preference concerning medical decisions; Autonomy-Preference-Index, modified German version (API-Dm).
The scale consists of a 11-item questionnaire with 4 questions on preferred autonomy in health-related decisions and 7 items on information preference.
The total results of the API and both subscales are transformed into a 0 - 100 scale with higher values indicating higher levels on autonomy and information preference, respectively.
|
At the beginning of the observation
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Extent of involvement in shared decision-making process
Time Frame: At the beginning of the observation
|
Extent of patients, relatives and health professionals' involvement in shared decision-making process; 9-Item Shared Decision Making Questionnaire (SDM-Q-9/SDM-Q-Doc)
|
At the beginning of the observation
|
Arm circumference
Time Frame: Up to one year
|
Arm circumference is measured in a standardized position and documented in centimeter.
|
Up to one year
|
Calf circumference
Time Frame: Up to one year
|
Calf circumference is measured in a standardized position and documented in centimeter.
|
Up to one year
|
Sarcopenia
Time Frame: Up to one year
|
Sarcopenia is evaluated as a composite measure by three criteria that are assessed: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference) and 3) low physical performance (gait speed).
|
Up to one year
|
Independence of Functional Status
Time Frame: Up to one year
|
Assessment of the patient's independence in mobilization, i.e. mobilization in daily living without personnel or device support.
|
Up to one year
|
Functional endurance
Time Frame: Up to one year
|
Functional endurance is measured using the 2-Minute-Step-Test (2-MST).
The patient steps in place, raising each leg to a marker.
The markers height is derived from biometrical measures of the patient.
The assessor counts each step of the right leg in which the knee of the patient passes the marker.
Higher counts of steps indicates better functional endurance.
|
Up to one year
|
Function of the respiratory system
Time Frame: Up to one year
|
The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.
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Up to one year
|
Depression
Time Frame: Up to one year
|
Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]
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Up to one year
|
Anxiety
Time Frame: Up to one year
|
Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)
|
Up to one year
|
Frequency of depressive and anxiety symptoms
Time Frame: Up to one year
|
Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]
|
Up to one year
|
Health related quality of life
Time Frame: Up to one year
|
Health related quality of life is measured with EQ-5D-5L questionnaire.
|
Up to one year
|
Patient-reported Functioning and Disability (WHO Disability Assessment) Schedule)
Time Frame: Up to one year
|
Patient-reported functioning and disability is measured by patient self report of functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version)
|
Up to one year
|
Proxy-reported Functioning and Disability (WHO Disability Assessment) Schedule)
Time Frame: Up to one year
|
Proxy-reported Functioning and Disability is measured by Proxy-rated functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item Version)
|
Up to one year
|
Falls
Time Frame: Up to one year
|
Incidence of falls
|
Up to one year
|
Fear of Falling
Time Frame: Up to one year
|
Activities-Specific Balance Confidence (ABC)-6-Scale.
The scale consists of 6 questions who are rated on a 0-100 NRS-scale.
The total result of the ABC-6-scale comprises of the average of all 6 items.
|
Up to one year
|
Social situation measurement 1
Time Frame: Up to one year
|
The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2).
|
Up to one year
|
Social situation measurement 2
Time Frame: Up to one year
|
The social situation 2 of the patient is measured by BSSS, 8-items
|
Up to one year
|
Pain: Numeric rating scale
Time Frame: Up to one year
|
Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain.
|
Up to one year
|
Satisfaction with the prehabilitation and overall process: ZUF-8
Time Frame: Up to one year
|
The satisfaction of the patient is measured with the questionnaire on patient satisfaction (ZUF-8).
The ZUF-8 is a questionnaire on patient satisfaction after treatment.
It consists of 8 questions which results in a score between 0 and 24 points, with higher values.indicating
higher levels of satisfaction.
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Up to one year
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Loneliness
Time Frame: Up to one year
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Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale
|
Up to one year
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Survival
Time Frame: Up to one year
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Data from patient records and residents' registration
|
Up to one year
|
Nutritional Status
Time Frame: Up to one year
|
Changes of nutritional status after elective surgery.
|
Up to one year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay Intensive Care Unit
Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
|
Intensive care unit length of stay describes every day spent in an ICU bed.
|
Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
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Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)
Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
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Admission rate (planned / unplanned) on ICU
|
Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
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Duration of hospital stay
Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
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Time in hospital
|
Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
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Adverse Discharge Disposition
Time Frame: Participants are followed up after hospital discharge for 1 day
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Adverse discharge disposition other than to home and planned rehabilitation facility.
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Participants are followed up after hospital discharge for 1 day
|
Necessity for follow-up treatment and rehabilitation
Time Frame: Up to one year
|
Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.
|
Up to one year
|
Count of new discharge diagnoses
Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
|
New medical diagnoses at hospital discharge compared to baseline are assessed.
|
Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
|
Count of new discharge medication
Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
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New medication at hospital discharge compared to baseline is assessed.
|
Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
|
Duration of rehabilitation
Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 25 days]
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Patient record data, discharge letter
|
Participants are followed up for the duration of rehabilitation, an expected average of 25 days]
|
Health economic benefit
Time Frame: Up to one year
|
ScreeningThe health economic benefit of the intervention (prehabilitation) will be compared to standard of care in the German health care system using a health cost analysis framework.
|
Up to one year
|
Adequacy of exercise interventions
Time Frame: Up to one year
|
Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines.
|
Up to one year
|
Evaluation of the nutritional intervention
Time Frame: Up to three weeks
|
Questionnaire on operability of the nutritional intervention and dietary records
|
Up to three weeks
|
Anesthesia duration
Time Frame: During surgery
|
Measured form anesthesia induction until stop of anesthesia (Patient records)
|
During surgery
|
Preoperative Cognitive Impairment
Time Frame: At baseline
|
For NCD diagnosis at baseline (Preoperative Cognitive Impairment) the same distinction criteria for mild and major NCD were applied, although here formal neurocognitive test performance at baseline was compared to the corresponding mean baseline value in the non-surgical control group.
|
At baseline
|
Assistive Devices (Hilfsmittel)
Time Frame: Up to one year
|
The need of any aid and device that is designed, made, or adapted to assist a patient perform a particular task.
|
Up to one year
|
Treatment (Heilmittel)
Time Frame: Up to one year
|
The need of a substance or method for curing an illness.
|
Up to one year
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Claudia Spies, Prof., MD, Charite University, Berlin, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRAEP-GO
- U1111-1253-4820 (Other Identifier: Universal Trial Number (UTN))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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