<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04418271</url>
  </required_header>
  <id_info>
    <org_study_id>PRAEP-GO</org_study_id>
    <secondary_id>U1111-1253-4820</secondary_id>
    <nct_id>NCT04418271</nct_id>
  </id_info>
  <brief_title>Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)</brief_title>
  <official_title>Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technische Universität Berlin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BARMER</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the effect of a shared decision-making conference and&#xD;
      three-week prehabilitation program on the outcome &quot;care dependency&quot; one year after surgery.&#xD;
      The cost-effectiveness of the intervention will also be evaluated in this N = 1400 patient,&#xD;
      national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group,&#xD;
      clinical trial.&#xD;
&#xD;
      The objective of PRÄP-GO is to establish and employ a suitable preoperative case-care&#xD;
      management system to improve the short and long-term outcome of elderly surgical patients&#xD;
      with signs of a frailty syndrome, improving postoperative quality of life and reducing care&#xD;
      dependency by a three-week individualized prehabilitation program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Degree of care dependency</measure>
    <time_frame>Up to one year</time_frame>
    <description>Assessment results in a degree of care dependency from personal help according to the German dependency assessment (= &quot;Neues Begutachtungs-Assessment&quot; (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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive Disorder (NCD)</measure>
    <time_frame>Up to one year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suspected Neurocognitive disorder by MiniCog</measure>
    <time_frame>Up to one year</time_frame>
    <description>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 &lt;3 points indicating a suspicion of dementia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suspected Dementia by MOCA</measure>
    <time_frame>Up to one year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suspected postoperative neurocognitive disorder (POCD)</measure>
    <time_frame>Up to one year</time_frame>
    <description>The non-computerized neuropsychological Trail Making Test are used as indicator screening test for relevant cognitive change after surgery. An increase of &gt;55 seconds in TMT-B test performance at three and/or 12 months after surgery compared to baseline is set as cut off.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frailty</measure>
    <time_frame>Up to one year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polypharmacy</measure>
    <time_frame>Up to one year</time_frame>
    <description>Measured by number of drug agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use</measure>
    <time_frame>Up to one year</time_frame>
    <description>Measured by number of drug agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tobacco Use</measure>
    <time_frame>Up to one year</time_frame>
    <description>Measured by Fagerstrom (Fagerstrom &amp; Schneider, 1989)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Neuromonitoring</measure>
    <time_frame>During surgery</time_frame>
    <description>Monitoring of electroencephalography during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of surgery</measure>
    <time_frame>Up to one year</time_frame>
    <description>Incidence of complications (intra- and post-operative)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomy Preference</measure>
    <time_frame>At the beginning of the observation</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of involvement in shared decision-making process</measure>
    <time_frame>At the beginning of the observation</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm circumference</measure>
    <time_frame>Up to one year</time_frame>
    <description>Arm circumference is measured in a standardized position and documented in centimeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calf circumference</measure>
    <time_frame>Up to one year</time_frame>
    <description>Calf circumference is measured in a standardized position and documented in centimeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini Nutritional Assessment-Short</measure>
    <time_frame>Up to one year</time_frame>
    <description>Nutritional Status is measured using Mini Nutritional Assessment-Short-form (MNA-SF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sarcopenia</measure>
    <time_frame>Up to one year</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Independence of Functional Status</measure>
    <time_frame>Up to one year</time_frame>
    <description>Assessment of the patient's independence in mobilization, i.e. mobilization in daily living without personnel or device support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional endurance</measure>
    <time_frame>Up to one year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function of the respiratory system</measure>
    <time_frame>Up to one year</time_frame>
    <description>The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Up to one year</time_frame>
    <description>Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Up to one year</time_frame>
    <description>Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of depressive and anxiety symptoms</measure>
    <time_frame>Up to one year</time_frame>
    <description>Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Up to one year</time_frame>
    <description>Health related quality of life is measured with EQ-5D-5L questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported Functioning and Disability (WHO Disability Assessment) Schedule)</measure>
    <time_frame>Up to one year</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proxy-reported Functioning and Disability (WHO Disability Assessment) Schedule)</measure>
    <time_frame>Up to one year</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls</measure>
    <time_frame>Up to one year</time_frame>
    <description>Incidence of falls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of Falling</measure>
    <time_frame>Up to one year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social situation measurement 1</measure>
    <time_frame>Up to one year</time_frame>
    <description>The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social situation measurement 2</measure>
    <time_frame>Up to one year</time_frame>
    <description>The social situation 2 of the patient is measured by BSSS, 8-items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain: Numeric rating scale</measure>
    <time_frame>Up to one year</time_frame>
    <description>Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the prehabilitation and overall process: ZUF-8</measure>
    <time_frame>Up to one year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loneliness</measure>
    <time_frame>Up to one year</time_frame>
    <description>Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>Up to one year</time_frame>
    <description>Data from patient records and residents' registration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of stay Intensive Care Unit</measure>
    <time_frame>Participants are followed up for the duration of rehabilitation, an expected average of 1 day]</time_frame>
    <description>Intensive care unit length of stay describes every day spent in an ICU bed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)</measure>
    <time_frame>Participants are followed up for the duration of rehabilitation, an expected average of 1 day]</time_frame>
    <description>Admission rate (planned / unplanned) on ICU</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>Participants are followed up for the duration of rehabilitation, an expected average of 7 days]</time_frame>
    <description>Time in hospital</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Discharge Disposition</measure>
    <time_frame>Participants are followed up after hospital discharge for 1 day</time_frame>
    <description>Adverse discharge disposition other than to home and planned rehabilitation facility.</description>
  </other_outcome>
  <other_outcome>
    <measure>Necessity for follow-up treatment and rehabilitation</measure>
    <time_frame>Up to one year</time_frame>
    <description>Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.</description>
  </other_outcome>
  <other_outcome>
    <measure>Count of new discharge diagnoses</measure>
    <time_frame>Participants are followed up for the duration of rehabilitation, an expected average of 7 days]</time_frame>
    <description>New medical diagnoses at hospital discharge compared to baseline are assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Count of new discharge medication</measure>
    <time_frame>Participants are followed up for the duration of rehabilitation, an expected average of 7 days]</time_frame>
    <description>New medication at hospital discharge compared to baseline is assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of rehabilitation</measure>
    <time_frame>Participants are followed up for the duration of rehabilitation, an expected average of 25 days]</time_frame>
    <description>Patient record data, discharge letter</description>
  </other_outcome>
  <other_outcome>
    <measure>Health economic benefit</measure>
    <time_frame>Up to one year</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adequacy of exercise interventions</measure>
    <time_frame>Up to one year</time_frame>
    <description>Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines.</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of the nutritional intervention</measure>
    <time_frame>Up to three weeks</time_frame>
    <description>Questionnaire on operability of the nutritional intervention and dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Anesthesia duration</measure>
    <time_frame>During surgery</time_frame>
    <description>Measured form anesthesia induction until stop of anesthesia (Patient records)</description>
  </other_outcome>
  <other_outcome>
    <measure>Preoperative Cognitive Impairment</measure>
    <time_frame>At baseline</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Assistive Devices (Hilfsmittel)</measure>
    <time_frame>Up to one year</time_frame>
    <description>The need of any aid and device that is designed, made, or adapted to assist a patient perform a particular task.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment (Heilmittel)</measure>
    <time_frame>Up to one year</time_frame>
    <description>The need of a substance or method for curing an illness.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Frailty</condition>
  <condition>Frail Elderly</condition>
  <arm_group>
    <arm_group_label>Prehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prefrail and frail patients receive prehabilitation (new form of care)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Prefrail and frail patients receive no prehabilitation, but receive standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prehabilitation- new form of care</intervention_name>
    <description>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.</description>
    <arm_group_label>Prehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Study patients:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 70 years&#xD;
&#xD;
          -  Consent by Patient or Legal Representative&#xD;
&#xD;
          -  Elective surgery planned&#xD;
&#xD;
          -  Expected anesthesia duration≥ 60 min&#xD;
&#xD;
          -  Statutory health insurance&#xD;
&#xD;
          -  Frailty syndrome (≥1 positive out of 5 standardized parameters according to the&#xD;
             Physical Frailty Phenotype according to Fried et. al.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiac or pulmonary disease (NYHA IV, Gold IV)&#xD;
&#xD;
          -  Intracranial interventions&#xD;
&#xD;
          -  Moribund patients (palliative situation)&#xD;
&#xD;
          -  Not enough language skills&#xD;
&#xD;
          -  Participation in another interventional rehabilitation study or other interventional&#xD;
             clinical trial that has not been approved by the study management committee&#xD;
             (Exception: Participation in adjuvant intervention study)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Spies, Prof., MD</last_name>
    <role>Study Chair</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claudia Spies, MD, Prof.</last_name>
    <phone>+49 30 450 531012</phone>
    <email>claudia.spies@charite.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Herz- und Diabetes Zentrum</name>
      <address>
        <city>Bad Oeynhausen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sascha Treskatsch, MD. Prof.</last_name>
      <phone>+49 30 450 55 15 22</phone>
      <email>sascha.treskatsch@charite.de</email>
    </contact>
    <investigator>
      <last_name>Sascha Treskatsch, MD, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudia Spies, MD, Prof.</last_name>
      <phone>+49 30 450 55 10 01</phone>
      <email>claudia.spies@charite.de</email>
    </contact>
    <investigator>
      <last_name>Claudia Spies, MD, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stefan Schaller, MD, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katrin Schmidt, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bundeswehrkrankenhaus</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CARITAS Klinik Maria Heimsuchung</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dominikus-Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus Hubertus</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Martin-Luther-Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Sankt Joseph Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Unfallkrankenhaus Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Frankfurt Oder GmbH</name>
      <address>
        <city>Frankfurt/Oder</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Greifswald</name>
      <address>
        <city>Greifswald</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sana Kliniken Sommerfeld</name>
      <address>
        <city>Kremmen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck</name>
      <address>
        <city>Lübeck</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München, LMU Campus Großhadern</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar - Technische Universität München</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>München Klinik Bogenhausen</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Havelland Kliniken GmbH - Klinik Nauen</name>
      <address>
        <city>Nauen</city>
        <zip>14641</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Havelland Kliniken-Klinik Rathenow</name>
      <address>
        <city>Rathenow</city>
        <zip>14712</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia Spies</investigator_full_name>
    <investigator_title>Univ.- Prof. Dr. Claudia Spies</investigator_title>
  </responsible_party>
  <keyword>Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418271
org study id: PRAEP-GO
secondary id: U1111-1253-4820
nct id: NCT04418271
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Degree of care dependency
time frame: Up to one year
description: 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.
measure: Neurocognitive Disorder (NCD)
time frame: Up to one year
description: 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.
measure: Suspected Neurocognitive disorder by MiniCog
time frame: Up to one year
description: 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.
measure: Suspected Dementia by MOCA
time frame: Up to one year
description: 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.
measure: Suspected postoperative neurocognitive disorder (POCD)
time frame: Up to one year
description: 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.
measure: Frailty
time frame: Up to one year
description: 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.
measure: Polypharmacy
time frame: Up to one year
description: Measured by number of drug agents
measure: Alcohol Use
time frame: Up to one year
description: Measured by number of drug agents
measure: Tobacco Use
time frame: Up to one year
description: Measured by Fagerstrom (Fagerstrom & Schneider, 1989)
measure: Intraoperative Neuromonitoring
time frame: During surgery
description: Monitoring of electroencephalography during surgery
measure: Result of surgery
time frame: Up to one year
description: Incidence of complications (intra- and post-operative)
measure: Autonomy Preference
time frame: At the beginning of the observation
description: 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.
measure: Extent of involvement in shared decision-making process
time frame: At the beginning of the observation
description: 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)
measure: Arm circumference
time frame: Up to one year
description: Arm circumference is measured in a standardized position and documented in centimeter.
measure: Calf circumference
time frame: Up to one year
description: Calf circumference is measured in a standardized position and documented in centimeter.
measure: Mini Nutritional Assessment-Short
time frame: Up to one year
description: Nutritional Status is measured using Mini Nutritional Assessment-Short-form (MNA-SF).
measure: Sarcopenia
time frame: Up to one year
description: 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).
measure: Independence of Functional Status
time frame: Up to one year
description: Assessment of the patient's independence in mobilization, i.e. mobilization in daily living without personnel or device support.
measure: Functional endurance
time frame: Up to one year
description: 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.
measure: Function of the respiratory system
time frame: Up to one year
description: The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.
measure: Depression
time frame: Up to one year
description: Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]
measure: Anxiety
time frame: Up to one year
description: Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)
measure: Frequency of depressive and anxiety symptoms
time frame: Up to one year
description: Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]
measure: Health related quality of life
time frame: Up to one year
description: Health related quality of life is measured with EQ-5D-5L questionnaire.
measure: Patient-reported Functioning and Disability (WHO Disability Assessment) Schedule)
time frame: Up to one year
description: 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)
measure: Proxy-reported Functioning and Disability (WHO Disability Assessment) Schedule)
time frame: Up to one year
description: 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)
measure: Falls
time frame: Up to one year
description: Incidence of falls
measure: Fear of Falling
time frame: Up to one year
description: 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.
measure: Social situation measurement 1
time frame: Up to one year
description: The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2).
measure: Social situation measurement 2
time frame: Up to one year
description: The social situation 2 of the patient is measured by BSSS, 8-items
measure: Pain: Numeric rating scale
time frame: Up to one year
description: Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain.
measure: Satisfaction with the prehabilitation and overall process: ZUF-8
time frame: Up to one year
description: 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.
measure: Loneliness
time frame: Up to one year
description: Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale
measure: Survival
time frame: Up to one year
description: Data from patient records and residents' registration
measure: Length of stay Intensive Care Unit
time frame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
description: Intensive care unit length of stay describes every day spent in an ICU bed.
measure: 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]
description: Admission rate (planned / unplanned) on ICU
measure: Duration of hospital stay
time frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
description: Time in hospital
measure: Adverse Discharge Disposition
time frame: Participants are followed up after hospital discharge for 1 day
description: Adverse discharge disposition other than to home and planned rehabilitation facility.
measure: Necessity for follow-up treatment and rehabilitation
time frame: Up to one year
description: Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.
measure: Count of new discharge diagnoses
time frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
description: New medical diagnoses at hospital discharge compared to baseline are assessed.
measure: Count of new discharge medication
time frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
description: New medication at hospital discharge compared to baseline is assessed.
measure: Duration of rehabilitation
time frame: Participants are followed up for the duration of rehabilitation, an expected average of 25 days]
description: Patient record data, discharge letter
measure: Health economic benefit
time frame: Up to one year
description: 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.
measure: Adequacy of exercise interventions
time frame: Up to one year
description: Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines.
measure: Evaluation of the nutritional intervention
time frame: Up to three weeks
description: Questionnaire on operability of the nutritional intervention and dietary records
measure: Anesthesia duration
time frame: During surgery
description: Measured form anesthesia induction until stop of anesthesia (Patient records)
measure: Preoperative Cognitive Impairment
time frame: At baseline
description: 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.
measure: Assistive Devices (Hilfsmittel)
time frame: Up to one year
description: The need of any aid and device that is designed, made, or adapted to assist a patient perform a particular task.
measure: Treatment (Heilmittel)
time frame: Up to one year
description: The need of a substance or method for curing an illness.
arm group label: Prehabilitation
arm group type: Experimental
description: Prefrail and frail patients receive prehabilitation (new form of care)
arm group label: Standard of Care
arm group type: No Intervention
description: Prefrail and frail patients receive no prehabilitation, but receive standard of care
intervention type: Behavioral
intervention name: Prehabilitation- new form of care
description: 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.
arm group label: Prehabilitation
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Claudia Spies, Prof., MD
role: Study Chair
affiliation: Charite University, Berlin, Germany
last name: Claudia Spies, MD, Prof.
phone: +49 30 450 531012
email: claudia.spies@charite.de
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Univ.- Prof. Dr. Claudia Spies
mesh term: Frailty
sharing ipd: No