Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)

Not Applicable

Completed

• Conditions: Frailty; Frail Elderly
• Interventions: Behavioral: Prehabilitation- new form of care

• Registration Number: NCT04418271
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-05
• Study Start: 2020-06-30
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Prehabilitation- new form of care	Prefrail and frail patients receive prehabilitation (new form of care)

Primary Outcome Measures

Name	Time	Method
Degree of care dependency	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.

Secondary Outcome Measures

Name	Time	Method
Every mobility	Up to one year	Level of everyday mobility using Life-Space Assessment (LSA)
Change in NBA score	Up to one year	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
NBA domain change	Up to one year	Change in individual domains of the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)).
Surrogate for Neurocognitive Disorder (NCD)	Up to one year	Frequency of neurocognitive vulnerability at 3 or 12 months as surrogate for NCD is measured as composite score: 1. Frequency of cognitive impairment/vulnerability is calculated from a change in composite of MiniCog, ANT, TMT-B and MOCA; 2. subjective concern (MMQ) and; 3. IADL/ADL
Screening tool for cognitive vulnerability	Up to one year	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.
Dementia risk assessed by MOCA	Up to one year	Dementia risk is assessed by Montreal Cognitive Assessment (MOCA-30) deterioration (change) and its absolute value if \< 26.
Extent of involvement in shared decision-making process	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)
Barthel Index	Up to one year	Level of care dependency after surgery reported as Barthel Index
Delirium	Up to one year	Delirium as perioperative complication assessed until hospital discharge using billing data.
Frailty	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.
Perioperative complications by Clavien-Dindo	Up to hospital discharge	Perioperative complications assessed using Clavien Dindo till hospital discharge
Autonomy Preference	At the beginning of the observation	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.
Arm circumference	Up to one year	Arm circumference is measured in a standardized position and documented in centimeter.
Calf circumference	Up to one year	Calf circumference is measured in a standardized position and documented in centimeter.
Nutritional Status	Up to one year	Changes of nutritional status after elective surgery.
Change in body weight	Up to one year	Changes in body weight measured in kg.
Instrumental Activities of daily living (IADL)	Up to one year	Instrumental Activities of daily living (IADL) using the questionnaire by Lawton and Brody.
Functional endurance	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.
Function of the respiratory system	Up to one year	The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.
Depression	Up to one year	Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)\]
Anxiety	Up to one year	Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)
Health related quality of life	Up to one year	Health related quality of life is measured with EQ-5D-5L questionnaire.
Disability by WHODAS 2.0	Up to one year	Patient- or proxy-reported functioning and disability is measured by the WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version.
Falls	Up to one year	Incidence of falls
Fear of Falling	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.
Satisfaction with the intervention: ZUF-8	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.
Mortality	Up to one year	Data from patient records and residents' registration
Stair climbing speed	Up to one year	Stair climbing speed test
Timed Up & Go Test (TUG	Up to one year	Timed Up \& Go Test (TUG) to test mobility and body balance
Length of stay Intensive Care Unit	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.
Muscle strength	Up to one year	Muscle strength measured by handgrip strength
Functional mobility	Up to one year	Functional mobility is measured with gait speed over 15ft
Postoperative functional mobility	Up to one year	Postoperative complication of mobilization speed measured with CHARMI
Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)	Participants are followed up for the duration of rehabilitation, an expected average of 1 day]	Admission rate (planned / unplanned) on ICU
Duration of hospital stay	Participants are followed up for the duration of rehabilitation, an expected average of 7 days]	Time in hospital

Trial Locations

Locations (23)

Herz- und Diabetes Zentrum; 🇩🇪 Bad Oeynhausen, Germany

Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin; 🇩🇪 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, Germany

Havelland Kliniken-Klinik Rathenow; 🇩🇪 Rathenow, Germany

Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, 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