Preoperative Optimization of Cardiac Valve Patients' Expectations (ValvEx)

September 18, 2023 updated by: Winfried Rief, Philipps University Marburg Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, 35037
        • UKGM Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group (IG)
Behavioral: EXPECT: Preoperative optimization of cardiac valve patient's expectations
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).
No Intervention: Standard of Care (SOC)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Items range from 0 (no restriction), 1 (nearly not restricted) - 5 (very strongly restricted). Consequently higher scores mean a worse outcome.
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
Time Frame: Baseline, up to one week post-surgery, up 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).
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
Time Frame: Baseline, up to one week post-surgery, up to three months post-surgery
Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.
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
Time Frame: Baseline, up to one week post-surgery, up to three months post-surgery
Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.
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
Time Frame: Baseline, 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.
Baseline, one day pre-surgery
Days the patient stays in the hospital, days at the intensive care unit
Time Frame: up to one week post-surgery
up to one week post-surgery
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
Change from baseline to postoperative day 1 (POD1) to approx. POD2 to approx. POD 5; higher scores mean a worse outcome.
Baseline, up to one day, two days and five days post-surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Items range from 1 (absolutely wrong) - 5 (absolutely right). Higher scores mean a better outcome.
Baseline, up to one week post-surgery, up to three months post-surgery
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
Items range from 1 (absolutely) - 5 (absolutely not). Higher scores mean a worse outcome.
Baseline, up to one week post-surgery, up to three months post-surgery
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
Items range from 0 (absolutely wrong) - 6 (absolutely right). Higher scores mean a better outcome.
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
Time Frame: Baseline, up to one week post-surgery, up to three months post-surgery
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.
Baseline, up to one week post-surgery, up to three months post-surgery
Personality (Big Five Inventory, BFI-10)
Time Frame: Baseline
Items range from 1 (disagree strongly) - 5 (agree strongly). The questionnaire includes the scales "openness to experience", "conscientiousness", "extraversion", agreeableness and neuroticism.
Baseline
Patients' experience with prior surgeries
Time Frame: Baseline
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).
Baseline
Surgery procedure (planned and realized)
Time Frame: Baseline, up to one week post-surgery
The planned and the realized surgical approach (minimally invasive or open) will be noted.
Baseline, up to one week post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart Centre Rotenburg
Justus-Liebig University Gießen Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ardawan Rastan, Prof. Dr., Cardiac surgery University Hospital Gießen und Marburg
  • Principal Investigator: Winfried Rief, Prof. Dr., Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ValvEx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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