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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1253-4820 | Other Identifier | Universal Trial Number (UTN) |
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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| Technische Universität Berlin | OTHER |
| BARMER | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | Prefrail and frail patients receive prehabilitation (new form of care) |
|
| Standard of Care | No Intervention | Prefrail and frail patients receive no prehabilitation, but receive standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation- new form of care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of care dependency | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index | Level of care dependency after surgery reported as Barthel Index | Up to one year |
| Change in NBA score | Assessment results according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008) using the results of the assessments on the scale from 0 to 100 points |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Discharge Disposition | Adverse discharge disposition other than to home and planned rehabilitation facility. | Participants are followed up after hospital discharge for 1 day |
| Necessity for follow-up treatment and rehabilitation |
Study patients:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, Prof., MD | Charite University, Berlin, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabetes Zentrum | Bad Oeynhausen | Germany | ||||
| Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42163295 | Derived | Rombey T, Eckhardt H, Quentin W, Weber Z, Buchka S, Kiselev J, Loidl V, Mansmann U, Schaller SJ, Schmidt K, Spies C, Busse R, Schoner L. Cost-effectiveness of prehabilitation for elderly (pre-)frail patients prior to elective surgery compared to standard care - an economic evaluation from a societal perspective. BMC Med. 2026 May 21;24(1):326. doi: 10.1186/s12916-026-04933-6. | |
| 41188708 |
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Patients with frailty syndrome (≥1 of the standardized parameters (Pre-Frail = 1-2; Frail≥3) according to Fried et al.(2001) are offered randomised participation in the new form of care.
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|
| Up to one year |
| NBA domain change | Change in individual domains of the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)). | Up to one year |
| Surrogate for Neurocognitive Disorder (NCD) | Frequency of neurocognitive vulnerability at 3 or 12 months as surrogate for NCD is measured as composite score:
| Up to one year |
| Screening tool for cognitive vulnerability | Cognitive vulnerability 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 cognitive vulnerability. | Up to one year |
| Dementia risk assessed by MOCA | Dementia risk is assessed by Montreal Cognitive Assessment (MOCA-30) deterioration (change) and its absolute value if < 26. | Up to one year |
| Delirium | Delirium as perioperative complication assessed until hospital discharge using billing data. | Up to one year |
| Frailty | 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 |
| Perioperative complications by Clavien-Dindo | Perioperative complications assessed using Clavien Dindo till hospital discharge | Up to hospital discharge |
| Every mobility | Level of everyday mobility using Life-Space Assessment (LSA) | Up to one year |
| Autonomy Preference | 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 |
| Extent of involvement in shared decision-making process | 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 | Arm circumference is measured in a standardized position and documented in centimeter. | Up to one year |
| Calf circumference | Calf circumference is measured in a standardized position and documented in centimeter. | Up to one year |
| Nutritional Status | Changes of nutritional status after elective surgery. | Up to one year |
| Change in body weight | Changes in body weight measured in kg. | Up to one year |
| Instrumental Activities of daily living (IADL) | Instrumental Activities of daily living (IADL) using the questionnaire by Lawton and Brody. | Up to one year |
| Functional endurance | 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 | The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter. | Up to one year |
| Depression | Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)] | Up to one year |
| Anxiety | Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7) | Up to one year |
| Health related quality of life | Health related quality of life is measured with EQ-5D-5L questionnaire. | Up to one year |
| Disability by WHODAS 2.0 | Patient- or proxy-reported functioning and disability is measured by the WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version. | Up to one year |
| Falls | Incidence of falls | Up to one year |
| Fear of Falling | 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 |
| Satisfaction with the intervention: ZUF-8 | 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. | Up to one year |
| Mortality | Data from patient records and residents' registration | Up to one year |
| Muscle strength | Muscle strength measured by handgrip strength | Up to one year |
| Functional mobility | Functional mobility is measured with gait speed over 15ft | Up to one year |
| Stair climbing speed | Stair climbing speed test | Up to one year |
| Timed Up & Go Test (TUG | Timed Up & Go Test (TUG) to test mobility and body balance | Up to one year |
| Postoperative functional mobility | Postoperative complication of mobilization speed measured with CHARMI | Up to one year |
| Length of stay Intensive Care Unit | 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] |
| Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU) | Admission rate (planned / unplanned) on ICU | Participants are followed up for the duration of rehabilitation, an expected average of 1 day] |
| Duration of hospital stay | Time in hospital | Participants are followed up for the duration of rehabilitation, an expected average of 7 days] |
Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.
| Up to one year |
| Count of new discharge diagnoses | 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 | 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 | Patient record data, discharge letter | Participants are followed up for the duration of rehabilitation, an expected average of 25 days] |
| Health economic benefit | 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 |
| Exercise adherence and planned prehabilitation composition | Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines. | Up to one year |
| Patient support | Patient support by need/prescription of assistive devices ("Hilfsmittel") and therapeutic treatment ("Heilmittel"). | Up to one year |
| Polypharmacy | Measured by number of drug agents | Up to one year |
| Alcohol Use | Measured by Alcohol Use Disorders Identification Test (AUDIT-C) | Up to one year |
| Tobacco Use | Measured by Fagerstrom (Fagerstrom & Schneider, 1989) | Up to one year |
| Sarcopenia | 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 or TUG). | Up to one year |
| Social situation measurement 1 | 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 | The social situation 2 of the patient is measured by BSSS, 8-items | Up to one year |
| Pain: Numeric rating scale | Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain. | Up to one year |
| Loneliness | Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale | Up to one year |
| Berlin |
| 12203 |
| Germany |
| Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH | Berlin | Germany |
| Bundeswehrkrankenhaus | Berlin | Germany |
| CARITAS Klinik Maria Heimsuchung | Berlin | Germany |
| Dominikus-Krankenhaus | Berlin | Germany |
| Evangelisches Krankenhaus Hubertus | Berlin | Germany |
| Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH | Berlin | Germany |
| Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH | Berlin | Germany |
| Martin-Luther-Krankenhaus | Berlin | Germany |
| Sankt Joseph Krankenhaus | Berlin | Germany |
| Unfallkrankenhaus Berlin | Berlin | Germany |
| Klinikum Frankfurt Oder GmbH | Frankfurt (Oder) | Germany |
| Universitätsmedizin Greifswald | Greifswald | 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 |
| Havelland Kliniken GmbH - Klinik Nauen | Nauen | 14641 | Germany |
| Havelland Kliniken-Klinik Rathenow | Rathenow | 14712 | Germany |
| Derived |
| Schone C, Fuchs TI, Kiselev J, Schmidt K, Schaller SJ, Spies C, Rombey T. Facilitators and barriers to participation in prehabilitation prior to orthopaedic elective surgery - a qualitative study with elderly (pre-)frail patients. BMC Geriatr. 2025 Nov 4;25(1):845. doi: 10.1186/s12877-025-06592-3. |
| 38448804 | Derived | Eckhardt H, Quentin W, Silzle J, Busse R, Rombey T. Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care - Protocol for a health economic evaluation alongside a randomized controlled trial. BMC Geriatr. 2024 Mar 6;24(1):231. doi: 10.1186/s12877-024-04833-5. |
| 35668532 | Derived | Schaller SJ, Kiselev J, Loidl V, Quentin W, Schmidt K, Morgeli R, Rombey T, Busse R, Mansmann U, Spies C; PRAEP-GO consortium,; PRAEP-GO investigators. Prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO): study protocol for a randomized, controlled, outcome assessor-blinded trial. Trials. 2022 Jun 6;23(1):468. doi: 10.1186/s13063-022-06401-x. |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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