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

Study Overview
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Brief Summary
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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.

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

Conditions
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Frailty, Frail Elderly

Intervention / Treatment
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* Behavioral: Prehabilitation- new form of care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>Prefrail and frail patients receive prehabilitation (new form of care) | Behavioral: Prehabilitation- new form of care<br>* 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.<br>|
| No Intervention: Standard of Care<br>Prefrail and frail patients receive no prehabilitation, but receive standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Polypharmacy | Measured by number of drug agents | Up to one year | 
| Alcohol Use | Measured by number of drug agents | Up to one year | 
| Tobacco Use | Measured by Fagerstrom (Fagerstrom & Schneider, 1989) | Up to one year | 
| Intraoperative Neuromonitoring | Monitoring of electroencephalography during surgery | During surgery | 
| Result of surgery | Incidence of complications (intra- and post-operative) | 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 | 
| Mini Nutritional Assessment-Short | Nutritional Status is measured using Mini Nutritional Assessment-Short-form (MNA-SF). | 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). | Up to one year | 
| 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 | 
| 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 | 
| Frequency of depressive and anxiety symptoms | Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)] | 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Loneliness | Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale | Up to one year | 
| Survival | Data from patient records and residents' registration | Up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery