Optimizing Expectations in Cardiac Surgery Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Philipps University Marburg Medical Center
Sponsor:
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01407055
First received: July 25, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to evaluate the potential benefit of targeting patients' expectations before coronary artery bypass graft surgery through a brief psychoeducational intervention.


Condition Intervention Phase
Coronary Artery Bypass Graft Surgery (CABG)
Patients' Expectations
Coronary Heart Disease
Behavioral: Expectation Manipulation Intervention
Behavioral: Supportive Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI) [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Patients' Expectations from Baseline/Pre-Intervention (expected average of 10 days before surgery) to hospital admission/Post-Intervention (expected average of 1 day before surgery). [ Time Frame: From 10 days before surgery untill 1 day before surgery ] [ Designated as safety issue: No ]
    Prospective Illness Perception 6 months after surgery (Expected Illness Perception Questionnaire; IPQ-E), Positive Health Expectation Scale (PHES), Expected Disability (PDI-E)

  • Change in Cardiac Anxiety (Cardiac Anxiety Questionnaire; CAQ) from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery ] [ Designated as safety issue: No ]
  • Change in Physical Activity (International Physical Activity Questionnaire; IPAQ) from Baseline (an expected average of 10 days before surgery) to 6 months after surgery. [ Time Frame: From 10 days before surgery to 6 months after surgery ] [ Designated as safety issue: No ]
  • Change in Health Related Quality of Life (SF-12) from Baseline (expected average of 10 days before surgery) to 6 months after surgery. [ Time Frame: From 10 days before surgery to 6 months after surgery ] [ Designated as safety issue: No ]
  • Change in physical symptoms, subjective side effects and post-surgery complaints (Generic Assessment of Side Effects Scale; GASE-P)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery ] [ Designated as safety issue: No ]
  • Change in Hospital Anxiety and Depression Scale (HADS)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ] [ Designated as safety issue: No ]
  • Change in Beliefs about Medications (Beliefs about Medications Questionaire; BMQ)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ] [ Designated as safety issue: No ]
  • Change in Working ability from Baseline (expected average of 10 days before surgery) to 6 months after surgery. [ Time Frame: From 10 days before surgery to 6 months after surgery. ] [ Designated as safety issue: No ]
  • Satisfaction wiht the intervention. [ Time Frame: Expected average of 1 day before surgery (but after the intervention). ] [ Designated as safety issue: No ]
  • Cardiothoracic surgeons' rating of the surgery success [ Time Frame: Expected average of 1 day after surgery ] [ Designated as safety issue: No ]
  • Additional treatments during follow-up [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Additional Treatments, rehospitalizations, cardiac sport groups, rehabilitations programms, etc.

  • Blinded Expert Rating of medical and psychological status at follow-up [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • Change in Sleep Quality from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ] [ Designated as safety issue: No ]
  • Change in neuroendocrine and immunological measures from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ] [ Designated as safety issue: No ]
    cortisol, inflammatory processes, catecholamines

  • Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

    From Patient file:

    Left ventricular ejection fraction (EF), Body Mass Index, Blood pressure, Smoking status, Cardiac Operative Risk (EuroSCORE), New York Heart Association classification (NYHA), Canadian Cardiovascular Society grading of angina pectoris (CCS), Number of diseased coronary vessels, Previous myocardial infarctions, extra-cardiac arteriopathy, non-cardiac comorbidities, surgery procedure, surgery complications and in-hospital post surgery complications, time spent on the intensive care unit, inpatient days until discharge


  • Patients' experience with prior surgeries [ Time Frame: Baseline (expected average of 10 days before surgery) ] [ Designated as safety issue: No ]
    Rating of experience with own prior surgeries. Rating of experience with surgeries of close others.

  • Enriched Social Support Inventory [ Time Frame: Baseline (expected average 10 days before surgery) ] [ Designated as safety issue: No ]
  • Occurrence of major life events since surgery [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • Change in Patients' Illness Perception (Brief Illness Perception Questionnaire (B-IPQ) from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery ] [ Designated as safety issue: No ]
  • Satisfaction with the intervention [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: July 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Medical Care
Patients receive standard treatment protocol for Coronary Artery Bypass Graft Surgery
Active Comparator: Attention Control Group
In addition to standard medical care patients receive a comparable amount of therapist´s attention (common and unspecific factors = supportive therapy) to the intervention group, without targeting patients' expectations.
Behavioral: Supportive Therapy
Supportive therapy employs common factors such as elicitation of affect, reflective listening, feeling understood, but provides no explicit theoretical formulation to the patient. Supportive therapy thus provides a control condition for common factors and therapist attention but lacks the specific intervention part. It will be delivered in the same frequency and at the same time points as the Expectation Manipulation Intervention (2 individual sessions, 2 phone calls).
Experimental: Expectation Manipulation Intervention
In addition to standard medical care patients' expectations prior to surgery are targeted in a brief psycho-educational intervention.
Behavioral: Expectation Manipulation Intervention
The Expectation Manipulation Intervention targets patients' expectations prior to surgery (2 individual sessions, 2 phone calls). Main goal is to enhance positive outcome expectancies, as well as to improve patients' control expectations about possible side effects of the surgery and about their personal management of their coronary heart disease. Further EMI tries to correct dysfunctional beliefs about the coronary heart disease and tries to minimize fears about expected negative consequences.

Detailed Description:

Coronary artery bypass graft surgery (CABG) is an extremely invasive medical intervention.It is postulated that even under these conditions, treatment outcome is substantially determined by non-specific effects, e.g. patient's expectation. Targeting patients' expectations at an early stage might have potential to optimize outcomes after cardiac surgery. The purpose of this research project is to optimize patients' outcome expectations before undergoing cardiac surgery through a brief psycho-educational program. Using a randomized controlled design, 180 patients who are scheduled to undergo elective CABG are randomly assigned either to standard medical information alone, or to an additional expectation manipulation intervention (EMI) during the two weeks before surgery, or to an attention-control group ("supportive therapy"). The main goal is to enhance positive expectations (surgery 'non-specific effects') about favorable outcome through EMI, about coping abilities to deal with adverse events, and to reduce negative expectations and misconceptions. Assessment takes place before and after EMI, 10 days after surgery and 6 months later; same assessment points are used for the 2 control conditions. Primary outcome is disability, which has been shown to be strongly determined by patient's expectation in previous studies. Moreover, psychological and biological predictors and mediators of treatment success are analyzed. A positive result for this expectation intervention would have major implications for clinical practice. In order to optimize treatment outcome, it is not only necessary to improve the treatment-specific procedures (e.g., cardiac surgery) but also to address non-specific factors such as patients' expectations.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled on the elective waiting list for first time coronary artery bypass graft surgery wiht the use of heart-lung-apparatus at the Department of Cardiovascular Surgery, Medical School, University of Marburg
  • Sufficient knowledge of German language
  • Ability to give informed consent

Exclusion Criteria:

  • Emergency surgery
  • Presence of a serious comorbid psychiatric condition
  • Presence of a life threatening comorbid medical condition
  • Current participation in other research
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407055

Contacts
Contact: Winfried Rief, Prof. Dr. 0049 6421 28 23657 rief@staff.uni-marburg.de
Contact: Johannes AC Laferton, Mag. 0049 6421 28 23655 laferton@staff.uni-marburg.de

Locations
Germany
Philipps University of Marburg Recruiting
Marburg, Hessen, Germany, 35032
Principal Investigator: Winfried Rief, Prof. Dr.         
Principal Investigator: Rainer Moosdorf, Prof. Dr.         
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
Principal Investigator: Winfried Rief, Prof. Dr. Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
Principal Investigator: Rainer Moosdorf, Prof. Dr. Department of Cardiac and Thoracic Vessel Surgery, Heart Centre, Philipps University of Marburg
  More Information

Additional Information:
No publications provided by Philipps University Marburg Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Winfried Rief, Prof. Dr. Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01407055     History of Changes
Other Study ID Numbers: DFG RI574/21-1
Study First Received: July 25, 2011
Last Updated: November 13, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
Coronary Artery Bypass Graft Surgery (CABG)
Patients' Expectations
Coronary Heart Disease
Illness Perception Intervention
Randomized Controlled Trial

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014