<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/NCT04502121</url>
  </required_header>
  <id_info>
    <org_study_id>ValvEx</org_study_id>
    <nct_id>NCT04502121</nct_id>
  </id_info>
  <brief_title>Preoperative Optimization of Cardiac Valve Patients' Expectations</brief_title>
  <acronym>ValvEx</acronym>
  <official_title>Preoperative Optimization of Cardiac Valve Patients' Expectations - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philipps University Marburg Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart Centre Rotenburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Justus-Liebig University Gießen Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Philipps University Marburg Medical Center</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>
      Recovery after surgery depends on psychological factors such as preoperative information,&#xD;
      expectations and surgery-associated anxiety. Prior studies have shown that even short&#xD;
      preoperative psychological interventions can improve postoperative outcomes in heart surgery&#xD;
      patients. However, what content works best for which patient group and how long an&#xD;
      intervention has to be is still largely unknown. The aims of this study are thus to examine&#xD;
      if the developed preoperative psychological intervention (i) reduces preoperative anxiety,&#xD;
      (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative&#xD;
      recovery. Therefore, a brief intervention has been developed. Heart valve patients who&#xD;
      undergo a heart surgery will be randomized into two groups (Control vs. intervention group)&#xD;
      after baseline assessment. Following this the intervention group will participate in the&#xD;
      psychological intervention (30-40 minutes). To increase patients' positive expectations the&#xD;
      intervention will focus on treatment outcome expectations and personal control expectations.&#xD;
      Furthermore, patients in the intervention group will have two booster-telephone calls (four&#xD;
      and eight weeks after the surgery) to check if their developed plans work out. The control&#xD;
      group will receive the standard medical procedure. Both groups will fill out questionnaires&#xD;
      again at the evening before the surgery, around one week after the surgery and three months&#xD;
      after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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 will be randomly allocated to the intervention group (IG) or the control group (SOC). The intervention group will receive a psychological preoperative intervention to optimize expectations (in addition to standard medical care). The control group will receive the standard of care only.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>The psychologist will inform the patient about the group s/he is randomly assigned to. The medical staff will not receive any information about the group a patient is allocated to and therefore be masked regarding group assignments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery</measure>
    <time_frame>Baseline, one day pre-surgery, up to one week post-surgery, up to three months post-surgery</time_frame>
    <description>Items range from 0 (no disability at all) - 10 (total disability). Consequently higher scores mean a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from Baseline to one week post-surgery to three months post-surgery</measure>
    <time_frame>Baseline, up to one week post-surgery, up to three months post-surgery</time_frame>
    <description>Items range from 0 (no restriction), 1 (nearly not restricted) - 5 (very strongly restricted). Consequently higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery</measure>
    <time_frame>Baseline, up to one week post-surgery, up to three months post-surgery</time_frame>
    <description>There are different item scales. The item scale of the first item (General health perceptions) ranges from 1 (excellent) to 5 (bad). The item scales of the second and third item (limitations in physical activities because of health problems) range from 1 (yes, absolutely restricted) to 2 (yes, a bit restricted) to 3 (no, not restricted at all). The item scales of the items 4-7 (limitations in usual role activities because of physical health or emotional problems) are just &quot;yes&quot; and &quot;no&quot;. The item scale of the eighth item (bodily pain) ranges from 1 (Absolutely not) to 5 (a lot). The item scales of the items 9-12 (general mental health, vitality and limitations in social activities because of physical or emotional problems) range from 1 (always) to 5 (never).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery</measure>
    <time_frame>Baseline, up to one week post-surgery, up to three months post-surgery</time_frame>
    <description>Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Generalized Anxiety Disorder 7 (GAD-7) from Baseline to one week post-surgery to three months post-surgery</measure>
    <time_frame>Baseline, up to one week post-surgery, up to three months post-surgery</time_frame>
    <description>Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety (The Amsterdam Preoperative Anxiety and Information Scale, APAIS) from Baseline to one day pre-surgery</measure>
    <time_frame>Baseline, one day pre-surgery</time_frame>
    <description>Items range from 1 (not at all) - 5 (extremely). Higher scores mean patients are more interested in information and do have greater worries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days the patient stays in the hospital, days at the intensive care unit</measure>
    <time_frame>up to one week post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Concentration of Inflammatory marker C-reactive protein (CRP) in mg/l</measure>
    <time_frame>Baseline, up to one day, two days and five days post-surgery</time_frame>
    <description>Change from baseline to postoperative day 1 (POD1) to approx. POD2 to approx. POD 5; higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to one day pre-surgery to one week post-surgery</measure>
    <time_frame>Baseline, one day pre-surgery, up to one week post-surgery</time_frame>
    <description>Items range from 0 (absolutely wrong) - 6 (absolutely right). Higher scores mean a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patients' Illness Perception (Brief Illness Perception Questionnaire, B-IPQ) from Baseline to 1 week post-surgery to 3 months after surgery</measure>
    <time_frame>Baseline, up to one week post-surgery, up to three months post-surgery</time_frame>
    <description>The B-IPQ surveys the cognitive and emotional representations of illness. Item 1-5 measure cognitive illness representations (consequences, timeline, personal control, treatment control, andidentity). Item 6 and 8 quantify emotional representations (concern &amp; emotions). Item 7 assesses illness comprehensibility. Item 9 is an open question (three most important causal factors in their illness). Items range from 0-10: item 1: no disability at all to very strong disability, item 2: really short to forever, item 3: no control at all zo extreme control, item 4: not at all to extremely helpful, item 5: no complaints at all to very much and strong complaints, item 6: no worries at all to extreme worries, item 7: not at all to very clear, item 8: emotionally not included at all to emotional extremely included.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in patients' expectations (Expected Illness Perception Questionnaire, IPQ-E) from Baseline to one week post-surgery to three months post-surgery</measure>
    <time_frame>Baseline, up to one week post-surgery, up to three months post-surgery</time_frame>
    <description>Items range from 1 (absolutely wrong) - 5 (absolutely right). Higher scores mean a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in patients optimism (Life-Orientation-Test Revised, LOT-R) from Baseline to one week post-surgery to three months post-surgery</measure>
    <time_frame>Baseline, up to one week post-surgery, up to three months post-surgery</time_frame>
    <description>Items range from 1 (absolutely) - 5 (absolutely not). Higher scores mean a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Personality (Big Five Inventory, BFI-10)</measure>
    <time_frame>Baseline</time_frame>
    <description>Items range from 1 (disagree strongly) - 5 (agree strongly). The questionnaire includes the scales &quot;openness to experience&quot;, &quot;conscientiousness&quot;, &quot;extraversion&quot;, agreeableness and neuroticism.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients' experience with prior surgeries</measure>
    <time_frame>Baseline</time_frame>
    <description>Rating of experience with own prior surgeries. Rating of experience with surgeries of close others. First patients are asked if they or close others had a prior surgery before (yes/no). If they answer yes, they are asked to rate their or their close others experience (item ranges from 1 (very bad) - 5 (very good).</description>
  </other_outcome>
  <other_outcome>
    <measure>Surgery procedure (planned and realized)</measure>
    <time_frame>Baseline, up to one week post-surgery</time_frame>
    <description>The planned and the realized surgical approach (minimally invasive or open) will be noted.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Cardiac Valve Disease</condition>
  <arm_group>
    <arm_group_label>Intervention group (IG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EXPECT: Preoperative optimization of cardiac valve patient's expectations</intervention_name>
    <description>The psychological, preoperative intervention follows a treatment manual. Patients get a personal intervention one day before surgery (30-40 minutes). It includes the development of an individual, subjectively perceived disease model, the treatment outcome expectations and the personalized outcome expectancy. Additionally they get two booster telephone calls 4 and 8 weeks after the surgery to recall the discussed topics and to talk about their recovery process (10-15 minutes).</description>
    <arm_group_label>Intervention group (IG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are scheduled for elective cardiac valve procedure&#xD;
&#xD;
          -  Age 18 or above&#xD;
&#xD;
          -  Fluency in German&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbid medical/psychiatric condition that causes more extensive disability than the&#xD;
             coronary condition&#xD;
&#xD;
          -  Participation in other research programs: in agreement with Coordinating Investigator&#xD;
             patient can participate substudies, if this do not interfere with the main study&#xD;
&#xD;
          -  Emergency surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Winfried Rief, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ardawan Rastan, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiac surgery University Hospital Gießen und Marburg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole Horn</last_name>
    <phone>+496421-2823341</phone>
    <email>Nicole.horn@staff.uni-marburg.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stefan Salzmann, Dr.</last_name>
    <phone>+496421-2823350</phone>
    <email>Stefan.salzmann@staff.uni-marburg.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UKGM Marburg</name>
      <address>
        <city>Marburg</city>
        <zip>35037</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ardawan J. Rastan, Prof. Dr.</last_name>
      <phone>+496421/58-66223</phone>
      <email>A.Rastan@uk-gm.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Auer CJ, Glombiewski JA, Doering BK, Winkler A, Laferton JA, Broadbent E, Rief W. Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis. Int J Behav Med. 2016 Feb;23(1):49-62. doi: 10.1007/s12529-015-9500-4.</citation>
    <PMID>26223485</PMID>
  </reference>
  <reference>
    <citation>Juergens MC, Seekatz B, Moosdorf RG, Petrie KJ, Rief W. Illness beliefs before cardiac surgery predict disability, quality of life, and depression 3 months later. J Psychosom Res. 2010 Jun;68(6):553-60. doi: 10.1016/j.jpsychores.2009.10.004. Epub 2009 Dec 5.</citation>
    <PMID>20488272</PMID>
  </reference>
  <reference>
    <citation>Laferton JA, Kube T, Salzmann S, Auer CJ, Shedden-Mora MC. Patients' Expectations Regarding Medical Treatment: A Critical Review of Concepts and Their Assessment. Front Psychol. 2017 Feb 21;8:233. doi: 10.3389/fpsyg.2017.00233. eCollection 2017.</citation>
    <PMID>28270786</PMID>
  </reference>
  <reference>
    <citation>Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.</citation>
    <PMID>8623940</PMID>
  </reference>
  <reference>
    <citation>Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.</citation>
    <PMID>28069021</PMID>
  </reference>
  <reference>
    <citation>Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.</citation>
    <PMID>16717171</PMID>
  </reference>
  <reference>
    <citation>Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.</citation>
    <PMID>8628042</PMID>
  </reference>
  <reference>
    <citation>Löwe, B., Spitzer, R. L., Zipfel, S., &amp; Herzog, W. (2002). PHQ-D Gesundheitsfragebogen für Patienten (German Version of the Patient Health Questionnaire). Karlsruhe: Pfizer.</citation>
  </reference>
  <reference>
    <citation>Rector TS, Kubo SH, Cohn JN. Validity of the Minnesota Living with Heart Failure questionnaire as a measure of therapeutic response to enalapril or placebo. Am J Cardiol. 1993 May 1;71(12):1106-7. doi: 10.1016/0002-9149(93)90582-w. No abstract available.</citation>
    <PMID>8475878</PMID>
  </reference>
  <reference>
    <citation>Rief, W., &amp; Glombiewski, J. A. (2016). Erwartungsfokussierte Psychotherapeutische Interventionen (EFPI). Verhaltenstherapie, 26(1), 47-54.</citation>
  </reference>
  <reference>
    <citation>Salzmann, S., Laferton, J., Auer, C., Shedden-Mora, M., Wambach, K., &amp; Rief, W. (2018). Patientenerwartungen optimieren: Beschreibung einer präoperativen Kurzintervention am Beispiel von Patienten vor einer Bypass-Operation. Verhaltenstherapie, 28(3), 157-165.</citation>
  </reference>
  <reference>
    <citation>Gaab, J. (2009). PASA-Primary Appraisal Secondary Appraisal-Ein Fragebogen zur Erfassung von situations-bezogenen kognitiven Bewertungen. Verhaltenstherapie, 19(2), 114-115.</citation>
  </reference>
  <reference>
    <citation>Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.</citation>
    <PMID>16731240</PMID>
  </reference>
  <reference>
    <citation>Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.</citation>
    <PMID>7815302</PMID>
  </reference>
  <reference>
    <citation>Rammstedt, B. und O. P. John, 2007: Measuring personality in one minute or less: A 10-item short version of the Big Five Inventory in English and German. Journal of Research in Personality 41: 203-212</citation>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Philipps University Marburg Medical Center</investigator_affiliation>
    <investigator_full_name>Winfried Rief</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Expectations</keyword>
  <keyword>Preoperative intervention</keyword>
  <keyword>placebo effect</keyword>
  <keyword>cardiac valve surgery</keyword>
  <keyword>clinical trial</keyword>
  <keyword>recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04502121
org study id: ValvEx
nct id: NCT04502121
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Recovery after surgery depends on psychological factors such as preoperative information,
      expectations and surgery-associated anxiety. Prior studies have shown that even short
      preoperative psychological interventions can improve postoperative outcomes in heart surgery
      patients. However, what content works best for which patient group and how long an
      intervention has to be is still largely unknown. The aims of this study are thus to examine
      if the developed preoperative psychological intervention (i) reduces preoperative anxiety,
      (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative
      recovery. Therefore, a brief intervention has been developed. Heart valve patients who
      undergo a heart surgery will be randomized into two groups (Control vs. intervention group)
      after baseline assessment. Following this the intervention group will participate in the
      psychological intervention (30-40 minutes). To increase patients' positive expectations the
      intervention will focus on treatment outcome expectations and personal control expectations.
      Furthermore, patients in the intervention group will have two booster-telephone calls (four
      and eight weeks after the surgery) to check if their developed plans work out. The control
      group will receive the standard medical procedure. Both groups will fill out questionnaires
      again at the evening before the surgery, around one week after the surgery and three months
      after surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomly allocated to the intervention group (IG) or the control group (SOC). The intervention group will receive a psychological preoperative intervention to optimize expectations (in addition to standard medical care). The control group will receive the standard of care only.
primary purpose: Treatment
masking: Single (Care Provider)
masking description: The psychologist will inform the patient about the group s/he is randomly assigned to. The medical staff will not receive any information about the group a patient is allocated to and therefore be masked regarding group assignments.
measure: Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery
time frame: Baseline, one day pre-surgery, up to one week post-surgery, up to three months post-surgery
description: Items range from 0 (no disability at all) - 10 (total disability). Consequently higher scores mean a worse outcome.
measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from Baseline to one week post-surgery to three months post-surgery
time frame: Baseline, up to one week post-surgery, up to three months post-surgery
description: Items range from 0 (no restriction), 1 (nearly not restricted) - 5 (very strongly restricted). Consequently higher scores mean a worse outcome.
measure: Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery
time frame: Baseline, up to one week post-surgery, up to three months post-surgery
description: There are different item scales. The item scale of the first item (General health perceptions) ranges from 1 (excellent) to 5 (bad). The item scales of the second and third item (limitations in physical activities because of health problems) range from 1 (yes, absolutely restricted) to 2 (yes, a bit restricted) to 3 (no, not restricted at all). The item scales of the items 4-7 (limitations in usual role activities because of physical health or emotional problems) are just "yes" and "no". The item scale of the eighth item (bodily pain) ranges from 1 (Absolutely not) to 5 (a lot). The item scales of the items 9-12 (general mental health, vitality and limitations in social activities because of physical or emotional problems) range from 1 (always) to 5 (never).
measure: Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery
time frame: Baseline, up to one week post-surgery, up to three months post-surgery
description: Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.
measure: Change in Generalized Anxiety Disorder 7 (GAD-7) from Baseline to one week post-surgery to three months post-surgery
time frame: Baseline, up to one week post-surgery, up to three months post-surgery
description: Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.
measure: Change in Anxiety (The Amsterdam Preoperative Anxiety and Information Scale, APAIS) from Baseline to one day pre-surgery
time frame: Baseline, one day pre-surgery
description: Items range from 1 (not at all) - 5 (extremely). Higher scores mean patients are more interested in information and do have greater worries.
measure: Days the patient stays in the hospital, days at the intensive care unit
time frame: up to one week post-surgery
measure: Change of Concentration of Inflammatory marker C-reactive protein (CRP) in mg/l
time frame: Baseline, up to one day, two days and five days post-surgery
description: Change from baseline to postoperative day 1 (POD1) to approx. POD2 to approx. POD 5; higher scores mean a worse outcome.
measure: Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to one day pre-surgery to one week post-surgery
time frame: Baseline, one day pre-surgery, up to one week post-surgery
description: Items range from 0 (absolutely wrong) - 6 (absolutely right). Higher scores mean a better outcome.
measure: Change in Patients' Illness Perception (Brief Illness Perception Questionnaire, B-IPQ) from Baseline to 1 week post-surgery to 3 months after surgery
time frame: Baseline, up to one week post-surgery, up to three months post-surgery
description: The B-IPQ surveys the cognitive and emotional representations of illness. Item 1-5 measure cognitive illness representations (consequences, timeline, personal control, treatment control, andidentity). Item 6 and 8 quantify emotional representations (concern & emotions). Item 7 assesses illness comprehensibility. Item 9 is an open question (three most important causal factors in their illness). Items range from 0-10: item 1: no disability at all to very strong disability, item 2: really short to forever, item 3: no control at all zo extreme control, item 4: not at all to extremely helpful, item 5: no complaints at all to very much and strong complaints, item 6: no worries at all to extreme worries, item 7: not at all to very clear, item 8: emotionally not included at all to emotional extremely included.
measure: Change in patients' expectations (Expected Illness Perception Questionnaire, IPQ-E) from Baseline to one week post-surgery to three months post-surgery
time frame: Baseline, up to one week post-surgery, up to three months post-surgery
description: Items range from 1 (absolutely wrong) - 5 (absolutely right). Higher scores mean a better outcome.
measure: Change in patients optimism (Life-Orientation-Test Revised, LOT-R) from Baseline to one week post-surgery to three months post-surgery
time frame: Baseline, up to one week post-surgery, up to three months post-surgery
description: Items range from 1 (absolutely) - 5 (absolutely not). Higher scores mean a worse outcome.
measure: Personality (Big Five Inventory, BFI-10)
time frame: Baseline
description: Items range from 1 (disagree strongly) - 5 (agree strongly). The questionnaire includes the scales "openness to experience", "conscientiousness", "extraversion", agreeableness and neuroticism.
measure: Patients' experience with prior surgeries
time frame: Baseline
description: Rating of experience with own prior surgeries. Rating of experience with surgeries of close others. First patients are asked if they or close others had a prior surgery before (yes/no). If they answer yes, they are asked to rate their or their close others experience (item ranges from 1 (very bad) - 5 (very good).
measure: Surgery procedure (planned and realized)
time frame: Baseline, up to one week post-surgery
description: The planned and the realized surgical approach (minimally invasive or open) will be noted.
arm group label: Intervention group (IG)
arm group type: Experimental
arm group label: Standard of Care (SOC)
arm group type: No Intervention
intervention type: Behavioral
intervention name: EXPECT: Preoperative optimization of cardiac valve patient's expectations
description: The psychological, preoperative intervention follows a treatment manual. Patients get a personal intervention one day before surgery (30-40 minutes). It includes the development of an individual, subjectively perceived disease model, the treatment outcome expectations and the personalized outcome expectancy. Additionally they get two booster telephone calls 4 and 8 weeks after the surgery to recall the discussed topics and to talk about their recovery process (10-15 minutes).
arm group label: Intervention group (IG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Winfried Rief, Prof. Dr.
role: Principal Investigator
affiliation: Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg
last name: Ardawan Rastan, Prof. Dr.
role: Principal Investigator
affiliation: Cardiac surgery University Hospital Gießen und Marburg
last name: Nicole Horn
phone: +496421-2823341
email: Nicole.horn@staff.uni-marburg.de
last name: Stefan Salzmann, Dr.
phone: +496421-2823350
email: Stefan.salzmann@staff.uni-marburg.de
facility: 
status: Recruiting
contact: 
country: Germany
citation: Auer CJ, Glombiewski JA, Doering BK, Winkler A, Laferton JA, Broadbent E, Rief W. Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis. Int J Behav Med. 2016 Feb;23(1):49-62. doi: 10.1007/s12529-015-9500-4.
PMID: 26223485
citation: Juergens MC, Seekatz B, Moosdorf RG, Petrie KJ, Rief W. Illness beliefs before cardiac surgery predict disability, quality of life, and depression 3 months later. J Psychosom Res. 2010 Jun;68(6):553-60. doi: 10.1016/j.jpsychores.2009.10.004. Epub 2009 Dec 5.
PMID: 20488272
citation: Laferton JA, Kube T, Salzmann S, Auer CJ, Shedden-Mora MC. Patients' Expectations Regarding Medical Treatment: A Critical Review of Concepts and Their Assessment. Front Psychol. 2017 Feb 21;8:233. doi: 10.3389/fpsyg.2017.00233. eCollection 2017.
PMID: 28270786
citation: Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
PMID: 8623940
citation: Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.
PMID: 28069021
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PMID: 16717171
citation: Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PMID: 8628042
citation: Löwe, B., Spitzer, R. L., Zipfel, S., & Herzog, W. (2002). PHQ-D Gesundheitsfragebogen für Patienten (German Version of the Patient Health Questionnaire). Karlsruhe: Pfizer.
citation: Rector TS, Kubo SH, Cohn JN. Validity of the Minnesota Living with Heart Failure questionnaire as a measure of therapeutic response to enalapril or placebo. Am J Cardiol. 1993 May 1;71(12):1106-7. doi: 10.1016/0002-9149(93)90582-w. No abstract available.
PMID: 8475878
citation: Rief, W., & Glombiewski, J. A. (2016). Erwartungsfokussierte Psychotherapeutische Interventionen (EFPI). Verhaltenstherapie, 26(1), 47-54.
citation: Salzmann, S., Laferton, J., Auer, C., Shedden-Mora, M., Wambach, K., & Rief, W. (2018). Patientenerwartungen optimieren: Beschreibung einer präoperativen Kurzintervention am Beispiel von Patienten vor einer Bypass-Operation. Verhaltenstherapie, 28(3), 157-165.
citation: Gaab, J. (2009). PASA-Primary Appraisal Secondary Appraisal-Ein Fragebogen zur Erfassung von situations-bezogenen kognitiven Bewertungen. Verhaltenstherapie, 19(2), 114-115.
citation: Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PMID: 16731240
citation: Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.
PMID: 7815302
citation: Rammstedt, B. und O. P. John, 2007: Measuring personality in one minute or less: A 10-item short version of the Big Five Inventory in English and German. Journal of Research in Personality 41: 203-212
responsible party type: Principal Investigator
investigator affiliation: Philipps University Marburg Medical Center
investigator full name: Winfried Rief
investigator title: Prof. Dr.
mesh term: Heart Valve Diseases
sharing ipd: Undecided