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

Frailty Clinical Trial

Official title:

Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04418271
• Other study ID #: PRAEP-GO
• Secondary ID: U1111-1253-4820
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 531012
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Frail Elderly
• Frailty

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Germany	Herz- und Diabetes Zentrum	Bad Oeynhausen
Germany	Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH	Berlin
Germany	Bundeswehrkrankenhaus	Berlin
Germany	CARITAS Klinik Maria Heimsuchung	Berlin
Germany	Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin	Berlin
Germany	Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin	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
Germany	Havelland Kliniken-Klinik Rathenow	Rathenow

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	BARMER, Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology, Technische Universität Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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]
Other	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]
Other	Duration of hospital stay	Time in hospital	Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Other	Adverse Discharge Disposition	Adverse discharge disposition other than to home and planned rehabilitation facility.	Participants are followed up after hospital discharge for 1 day
Other	Necessity for follow-up treatment and rehabilitation	Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.	Up to one year
Other	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]
Other	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]
Other	Duration of rehabilitation	Patient record data, discharge letter	Participants are followed up for the duration of rehabilitation, an expected average of 25 days]
Other	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
Other	Adequacy of exercise interventions	Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines.	Up to one year
Other	Evaluation of the nutritional intervention	Questionnaire on operability of the nutritional intervention and dietary records	Up to three weeks
Other	Anesthesia duration	Measured form anesthesia induction until stop of anesthesia (Patient records)	During surgery
Other	Preoperative Cognitive Impairment	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
Other	Assistive Devices (Hilfsmittel)	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
Other	Treatment (Heilmittel)	The need of a substance or method for curing an illness.	Up to one year
Primary	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
Secondary	Neurocognitive Disorder (NCD)	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
Secondary	Suspected Neurocognitive disorder by MiniCog	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
Secondary	Suspected Dementia by MOCA	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
Secondary	Suspected postoperative neurocognitive disorder (POCD)	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
Secondary	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
Secondary	Polypharmacy	Measured by number of drug agents	Up to one year
Secondary	Alcohol Use	Measured by number of drug agents	Up to one year
Secondary	Tobacco Use	Measured by Fagerstrom (Fagerstrom & Schneider, 1989)	Up to one year
Secondary	Intraoperative Neuromonitoring	Monitoring of electroencephalography during surgery	During surgery
Secondary	Result of surgery	Incidence of complications (intra- and post-operative)	Up to one year
Secondary	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
Secondary	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
Secondary	Arm circumference	Arm circumference is measured in a standardized position and documented in centimeter.	Up to one year
Secondary	Calf circumference	Calf circumference is measured in a standardized position and documented in centimeter.	Up to one year
Secondary	Nutritional Status	Changes of nutritional status after elective surgery.	Up to one year
Secondary	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).	Up to one year
Secondary	Independence of Functional Status	Assessment of the patient's independence in mobilization, i.e. mobilization in daily living without personnel or device support.	Up to one year
Secondary	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
Secondary	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
Secondary	Depression	Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]	Up to one year
Secondary	Anxiety	Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)	Up to one year
Secondary	Frequency of depressive and anxiety symptoms	Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]	Up to one year
Secondary	Health related quality of life	Health related quality of life is measured with EQ-5D-5L questionnaire.	Up to one year
Secondary	Patient-reported Functioning and Disability (WHO Disability Assessment) Schedule)	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
Secondary	Proxy-reported Functioning and Disability (WHO Disability Assessment) Schedule)	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
Secondary	Falls	Incidence of falls	Up to one year
Secondary	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
Secondary	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
Secondary	Social situation measurement 2	The social situation 2 of the patient is measured by BSSS, 8-items	Up to one year
Secondary	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
Secondary	Satisfaction with the prehabilitation and overall process: 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
Secondary	Loneliness	Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale	Up to one year
Secondary	Survival	Data from patient records and residents' registration	Up to one year