AzTrials
AzTrials

Cardiac Valve DiseaseValvExNCT04502121

Preoperative Optimization of Cardiac Valve Patients' Expectations

A study testing EXPECT: Preoperative optimization of cardiac valve patient's expectations in people with Cardiac Valve Disease, run by Philipps University Marburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Valve Disease
What is being tested?
EXPECT: Preoperative optimization of cardiac valve patient's expectations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteGermany
Study dates
17 Jul 2020to 7 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • UKGM Marburg

    Marburg, 35037

Other trials in Germany

About this study

Official title: Preoperative Optimization of Cardiac Valve Patients' Expectations - a Randomized Controlled Trial

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.

Being tested
EXPECT: Preoperative optimization of cardiac valve patient's expectations
Keywords
Expectations, Preoperative intervention, placebo effect, cardiac valve surgery, clinical trial, recovery
Medical subject headings
Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXPECT: Preoperative optimization of cardiac valve patient's expectationsBehavioural

    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).

Study groups in NCT04502121
Study groupRoleWhat they receive
Intervention group (IG)ExperimentalNot described
Receives: Behavioral: EXPECT: Preoperative optimization of cardiac valve patient's expectations
Standard of Care (SOC)No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

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

    Items range from 0 (no restriction), 1 (nearly not restricted) - 5 (very strongly restricted). Consequently higher scores mean a worse outcome.

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

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

    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).

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

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

    Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.

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

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

    Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.

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

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

    Items range from 1 (not at all) - 5 (extremely). Higher scores mean patients are more interested in information and do have greater worries.

    Measured: Baseline, one day pre-surgery

  6. Days the patient stays in the hospital, days at the intensive care unit

    Measured: up to one week post-surgery

  7. Change of Concentration of Inflammatory marker C-reactive protein (CRP) in mg/l

    Change from baseline to postoperative day 1 (POD1) to approx. POD2 to approx. POD 5; higher scores mean a worse outcome.

    Measured: Baseline, up to one day, two days and five days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start17 Jul 2020
  3. Primary completion29 Nov 2022
  4. Study completion7 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Care provider
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04502121
Sponsor's protocol ID
ValvEx
Acronym
ValvEx
Status last verified
Sep 2023
First submitted
23 Jun 2020
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26223485

  • 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.

    PubMed 20488272

  • 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.

    PubMed 28270786

  • 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.

    PubMed 8623940

  • 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.

    PubMed 28069021

  • 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.

    PubMed 16717171

  • 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.

    PubMed 8628042

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

  • 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.

    PubMed 8475878

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

  • 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.

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

  • 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.

    PubMed 16731240

  • 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.

    PubMed 7815302

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing EXPECT: Preoperative optimization of cardiac valve patient's expectations in people with Cardiac Valve Disease, run by Philipps University Marburg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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 (time frame: Baseline, one day pre-surgery, up to one week post-surgery, up to three months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502121, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in