Preoperative Optimization of Cardiac Valve Patients' Expectations

NCT04502121 | Completed

• 1 other identifier: ValvEx
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Valve Disease

Keywords

Expectations; Preoperative intervention; placebo effect; cardiac valve surgery; clinical trial; recovery

Outcome Measures

Primary Outcomes (1)

• Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery

  Items range from 0 (no disability at all) - 10 (total disability). Consequently higher scores mean a worse outcome.

  Baseline, one day pre-surgery, up to one week post-surgery, up to three months post-surgery

Secondary Outcomes (7)

• Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from Baseline to one week post-surgery to three months post-surgery

  Baseline, up to one week post-surgery, up to three months post-surgery

• Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery

  Baseline, up to one week post-surgery, up to three months post-surgery

• Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery

  Baseline, up to one week post-surgery, up to three months post-surgery

• Change in Generalized Anxiety Disorder 7 (GAD-7) from Baseline to one week post-surgery to three months post-surgery

  Baseline, up to one week post-surgery, up to three months post-surgery

• Change in Anxiety (The Amsterdam Preoperative Anxiety and Information Scale, APAIS) from Baseline to one day pre-surgery

  Baseline, one day pre-surgery

Other Outcomes (7)

• Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to one day pre-surgery to one week post-surgery

  Baseline, one day pre-surgery, up to one week post-surgery

• Change in Patients' Illness Perception (Brief Illness Perception Questionnaire, B-IPQ) from Baseline to 1 week post-surgery to 3 months after surgery

  Baseline, up to one week post-surgery, up to three months post-surgery

• Change in patients' expectations (Expected Illness Perception Questionnaire, IPQ-E) from Baseline to one week post-surgery to three months post-surgery

  Baseline, up to one week post-surgery, up to three months post-surgery

Study Arms (2)

Intervention group (IG)

EXPERIMENTAL

Behavioral: EXPECT: Preoperative optimization of cardiac valve patient's expectations

Standard of Care (SOC)

NO INTERVENTION

Interventions

EXPECT: Preoperative optimization of cardiac valve patient's expectations BEHAVIORAL

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).

Intervention group (IG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled for elective cardiac valve procedure
• Age 18 or above
• Fluency in German
• Informed consent

You may not qualify if:

• Comorbid medical/psychiatric condition that causes more extensive disability than the coronary condition
• Participation in other research programs: in agreement with Coordinating Investigator patient can participate substudies, if this do not interfere with the main study
• Emergency surgery

Sponsors & Collaborators

• Philipps University Marburg: lead
• Heart Centre Rotenburg: collaborator
• Justus-Liebig University Gießen Medical Center: collaborator

Study Sites (1)

UKGM Marburg

Marburg, 35037, Germany

Location

Related Publications (17)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Löwe, B., Spitzer, R. L., Zipfel, S., & Herzog, W. (2002). PHQ-D Gesundheitsfragebogen für Patienten (German Version of the Patient Health Questionnaire). Karlsruhe: Pfizer.

  BACKGROUND

• 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 BACKGROUND

• Rief, W., & Glombiewski, J. A. (2016). Erwartungsfokussierte Psychotherapeutische Interventionen (EFPI). Verhaltenstherapie, 26(1), 47-54.

  BACKGROUND

• 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.

  BACKGROUND

• Gaab, J. (2009). PASA-Primary Appraisal Secondary Appraisal-Ein Fragebogen zur Erfassung von situations-bezogenen kognitiven Bewertungen. Verhaltenstherapie, 19(2), 114-115.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• Horn N, Gartner L, Rastan AJ, Andrasi TB, Lenz J, Boning A, Salzmann-Djufri M, Puvogel U, Niemann B, Genovese M, Habash S, Euteneuer F, Rief W, Salzmann S. Effects of a preoperative psychological expectation-focused intervention in patients undergoing valvular surgery - the randomized controlled ValvEx (valve patients' expectations) study. Am Heart J. 2025 Apr;282:156-169. doi: 10.1016/j.ahj.2025.01.006. Epub 2025 Jan 17.

  PMID: 39827935 DERIVED

• Horn N, Gartner L, Rastan AJ, Andrasi TB, Lenz J, Boning A, Salzmann-Djufri M, Puvogel U, Genovese M, Kus S, Rief W, Salzmann S. Preoperative optimization of cardiac valve patients' expectations: Study protocol of the randomized controlled ValvEx-trial. Front Cardiovasc Med. 2023 Mar 2;10:1105507. doi: 10.3389/fcvm.2023.1105507. eCollection 2023.

  PMID: 36937912 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Winfried Rief, Prof. Dr.

  Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg

  PRINCIPAL INVESTIGATOR

• Ardawan Rastan, Prof. Dr.

  Cardiac surgery University Hospital Gießen und Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: August 6, 2020
• Study Start: July 17, 2020
• Primary Completion: November 29, 2022
• Study Completion: July 7, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

DE (1)