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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418271
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology
Technische Universität Berlin
BARMER
Information provided by (Responsible Party):
Claudia Spies, 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.


Condition or disease Intervention/treatment Phase
Frailty Frail Elderly Behavioral: Prehabilitation- new form of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Arm Intervention/treatment
Experimental: Prehabilitation
Prefrail and frail patients receive prehabilitation (new form of care)
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.

No Intervention: Standard of Care
Prefrail and frail patients receive no prehabilitation, but receive standard of care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Polypharmacy [ Time Frame: Up to one year ]
    Measured by number of drug agents

  7. Alcohol Use [ Time Frame: Up to one year ]
    Measured by number of drug agents

  8. Tobacco Use [ Time Frame: Up to one year ]
    Measured by Fagerstrom (Fagerstrom & Schneider, 1989)

  9. Intraoperative Neuromonitoring [ Time Frame: During surgery ]
    Monitoring of electroencephalography during surgery

  10. Result of surgery [ Time Frame: Up to one year ]
    Incidence of complications (intra- and post-operative)

  11. Autonomy Preference [ Time Frame: 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.

  12. 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)

  13. Arm circumference [ Time Frame: Up to one year ]
    Arm circumference is measured in a standardized position and documented in centimeter.

  14. Calf circumference [ Time Frame: Up to one year ]
    Calf circumference is measured in a standardized position and documented in centimeter.

  15. Mini Nutritional Assessment-Short [ Time Frame: Up to one year ]
    Nutritional Status is measured using Mini Nutritional Assessment-Short-form (MNA-SF).

  16. 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).

  17. 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.

  18. 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.

  19. 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.

  20. Depression [ Time Frame: Up to one year ]
    Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]

  21. Anxiety [ Time Frame: Up to one year ]
    Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)

  22. Frequency of depressive and anxiety symptoms [ Time Frame: Up to one year ]
    Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]

  23. Health related quality of life [ Time Frame: Up to one year ]
    Health related quality of life is measured with EQ-5D-5L questionnaire.

  24. 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)

  25. 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)

  26. Falls [ Time Frame: Up to one year ]
    Incidence of falls

  27. 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.

  28. 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).

  29. Social situation measurement 2 [ Time Frame: Up to one year ]
    The social situation 2 of the patient is measured by BSSS, 8-items

  30. 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.

  31. 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.

  32. Loneliness [ Time Frame: Up to one year ]
    Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale

  33. Survival [ Time Frame: Up to one year ]
    Data from patient records and residents' registration


Other Outcome Measures:
  1. 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.

  2. 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] ]
    Admission rate (planned / unplanned) on ICU

  3. Duration of hospital stay [ Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days] ]
    Time in hospital

  4. Adverse Discharge Disposition [ Time Frame: Participants are followed up after hospital discharge for 1 day ]
    Adverse discharge disposition other than to home and planned rehabilitation facility.

  5. 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.

  6. 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.

  7. Count of new discharge medication [ Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days] ]
    New medication at hospital discharge compared to baseline is assessed.

  8. Duration of rehabilitation [ Time Frame: Participants are followed up for the duration of rehabilitation, an expected average of 25 days] ]
    Patient record data, discharge letter

  9. 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.

  10. 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.

  11. Evaluation of the nutritional intervention [ Time Frame: Up to three weeks ]
    Questionnaire on operability of the nutritional intervention and dietary records

  12. Anesthesia duration [ Time Frame: During surgery ]
    Measured form anesthesia induction until stop of anesthesia (Patient records)

  13. 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.

  14. 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.

  15. Treatment (Heilmittel) [ Time Frame: Up to one year ]
    The need of a substance or method for curing an illness.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418271


Contacts
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Contact: Claudia Spies, MD, Prof. +49 30 450 531012 claudia.spies@charite.de

Locations
Show Show 23 study locations
Sponsors and Collaborators
Charite University, Berlin, Germany
Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology
Technische Universität Berlin
BARMER
Investigators
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Study Chair: Claudia Spies, Prof., MD Charite University, Berlin, Germany
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Responsible Party: Claudia Spies, Univ.- Prof. Dr. Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04418271    
Other Study ID Numbers: PRAEP-GO
U1111-1253-4820 ( Other Identifier: Universal Trial Number (UTN) )
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claudia Spies, Charite University, Berlin, Germany:
Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery
Additional relevant MeSH terms:
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Frailty
Pathologic Processes