Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery (INCREASE)

December 8, 2024 updated by: Evaldas Girdauskas, Universitätsklinikum Hamburg-Eppendorf

Interdisciplinary and Cross-sectoral Perioperative Care Model in the Cardiac Surgery: Implementation in the Setting of Minimally-invasive Heart Valve Surgery (INCREASE)

Valvular heart diseases are among the most common cardiac pathologies in adult patients in Germany. Currently, the process of care before, during and after heart valve surgery does not follow a standardized and interdisciplinary optimal approach. An approach already established in other surgical disciplines is the Enhanced Recovery After Surgery (ERAS) protocol, which aims at optimizing the recovery process of patients. Within the INCREASE study, a care process inspired by the ERAS protocol will be established at the University Heart and Vascular Center (UHZ) of the University Medical Center Hamburg-Eppendorf (UKE) and the University Medical Center Augsburg (UKA). Executing the study at two facilities in different regions in Germany will help to demonstrate transferability of the process of care. The effectiveness of this process compared to the current treatment approach will be investigated in a randomized controlled trial. A total of 186 patients will be allocated by chance either to the intervention group (ERAS protocol) or the control group (treatment as usual). Patients in the intervention group will receive an optimized interdisciplinary care protocol including medical, nursing, physiotherapeutical and psychotherapeutical interventions. Measurements of effectiveness are the number of hospitalized days (due to cardiac causes) within one year and the physical condition of the patient as measured by the 6-minute walk test (6MWT) on the day of discharge.

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.
201

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jelena Bagnjuk, MSc
  • Phone Number: + 49 40 7410 58685
  • Email: j.bagnjuk@uke.de

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Universitätsklinikum Augsburg

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:

  • Indication for elective minimally invasive (open) aortic or mitral valve surgery
  • Patient's ability to understand the nature and extent of the individual's requirements for participation in the new care setting
  • Classification of the patient as "FIT" or "Pre-FRAIL" using the LUCAS functional index (frailty index) (Dapp et al. 2012)

Exclusion Criteria:

  • Limited life expectancy less than one year (e.g., advanced tumor disease)
  • Urgent or emergency interventions
  • Severe chronic obstructive pulmonary disease (GOLD III or IV)
  • Dialysis-dependant renal failure
  • Advanced liver cirrhosis (Child stages B + C)
  • Severe comorbidities or psychosocial reasons that militate against participation or do not allow for written informed consent (e. g., residual neurological impairment after prior stroke, major restrictions of mobility, neuropsychological disorders, depressive disorder, substance-related addictive disorders)
  • Lack of a social environment that can provide supportive patient care
  • Previous cardiac surgery (i.e., relative contraindication for minimally invasive technique)

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: ERAS protocol (intervention group)
The innovative care process in the intervention group is characterized by an interdisciplinary approach according to the previously established enhanced recovery after surgery protocol. This process aims at improving the clinical outcome after cardiac surgery, increasing patient satisfaction and quality of life, enabling early professional reentry and participation, and optimizing the cost-effectiveness of service provision. In addition, intersectoral barriers are being broken down in order to establish an interdisciplinary and cross-sectoral overall care process for patients with heart valve surgery as a new form of care in the future.
Other: Enhanced Recovery After Surgery
Enhanced recovery after surgery is a multimodal, transdisciplinary care approach for patients undergoing surgical procedures. It is implemented in various surgical specialties, among others in cardiac surgery. The care approach aims at promotion of recovery of the patients throughout their perioperative process, reduction of complications, and early return to normal activities.
Other Names:
  • ERAS
  • fast track
  • rapid recovery
Active Comparator: Treatment as usual (control group)
The control group undergoes standard heart valve surgery. In this case, no preoperative interventions take place, the patient is operated on the affected heart valve in a minimally invasive procedure without prehabilitation. After surgery, the patient is transfered to an intensive care unit (not a specialized postanesthesia care unit) depending on the individual condition and then transfered to the general ward. Patients receive medical, nursing, and physiotherapeutic care in accordance with current hospital standards.
Other: Treatment as Usual
treatment as usual according to standard care in heart valve surgery

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
Hospitalization
Time Frame: twelve months
number of hospitalized days due to cardiac reasons
twelve months
Six Minute Walk Test
Time Frame: day of discharge (approx. 5 - 10 days after operation)
physical capacity expressed with the walking distance in meters
day of discharge (approx. 5 - 10 days after operation)

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
Goal Attainment Scale (GAS)
Time Frame: three months
level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected
three months
Goal Attainment Scale (GAS)
Time Frame: twelve months
level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected
twelve months
HeartQoL
Time Frame: three months
health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life
three months
HeartQoL
Time Frame: twelve months
health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life
twelve months
Costs
Time Frame: up to 10 days
direct costs in € associated with the operative procedure and the initial hospitalization using diagnosis related groups as classification system, in which diagnoses and treatments are valued according to their necessary economical expenditure
up to 10 days

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
European Health Literacy Questionnaire (HLS-EU-Q16)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy
day of discharge (approx. 5 - 10 days after operation)
European Health Literacy Questionnaire (HLS-EU-Q16)
Time Frame: twelve months
health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy
twelve months
Brief Illnness Perception Questionnaire (BIPQ)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception
day of discharge (approx. 5 - 10 days after operation)
Brief Illnness Perception Questionnaire (BIPQ)
Time Frame: twelve months
individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception
twelve months
Treatment Expectation Questionnaire (TEX-Q)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment
day of discharge (approx. 5 - 10 days after operation)
Treatment Expectation Questionnaire (TEX-Q)
Time Frame: three months
treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment
three months
Treatment Expectation Questionnaire (TEX-Q)
Time Frame: twelve months
treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment
twelve months
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms
day of discharge (approx. 5 - 10 days after operation)
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: three months
depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms
three months
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: twelve months
depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms
twelve months
Generalized Anxiety Disorder-2 (GAD-2)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms
day of discharge (approx. 5 - 10 days after operation)
Generalized Anxiety Disorder-2 (GAD-2)
Time Frame: three months
anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms
three months
Generalized Anxiety Disorder-2 (GAD-2)
Time Frame: twelve months
anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms
twelve months
Cardiac Anxiety Questionnaire (CAQ)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety
day of discharge (approx. 5 - 10 days after operation)
Cardiac Anxiety Questionnaire (CAQ)
Time Frame: three months
cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety
three months
Cardiac Anxiety Questionnaire (CAQ)
Time Frame: twelve months
cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety
twelve months
Life Orientation Test - revised (LOT-R)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
optimism; 10 items, min 0, max 24, higher scores indicating higher optimism
day of discharge (approx. 5 - 10 days after operation)
Somatic Symptom Scale-8 (SSS-8)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden
day of discharge (approx. 5 - 10 days after operation)
Somatic Symptom Scale-8 (SSS-8)
Time Frame: three months
somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden
three months
Somatic Symptom Scale-8 (SSS-8)
Time Frame: twelve months
somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden
twelve months
Somatic Symptom Disorder - B Criteria Scale (SSD-12)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms
day of discharge (approx. 5 - 10 days after operation)
Somatic Symptom Disorder - B Criteria Scale (SSD-12)
Time Frame: three months
coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms
three months
Somatic Symptom Disorder - B Criteria Scale (SSD-12)
Time Frame: twelve months
coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms
twelve months
International Physical Activity Questionnaire Short Form (IPAQ)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
level of physical activity
day of discharge (approx. 5 - 10 days after operation)
International Physical Activity Questionnaire Short Form (IPAQ)
Time Frame: twelve months
level of physical activity
twelve months
Hand Dynamometer
Time Frame: day of discharge (approx. 5 - 10 days after operation)
hand grip strength
day of discharge (approx. 5 - 10 days after operation)
Hand Dynamometer
Time Frame: twelve months
hand grip strength
twelve months
1 Minute Sit to Stand Test (1STS)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
physical capacity expressed with the number of repetitions
day of discharge (approx. 5 - 10 days after operation)
1 Minute Sit to Stand Test (1STS)
Time Frame: twelve months
physical capacity expressed with the number of repetitions
twelve months
Timed Up and Go (TUG)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
physical capacity expressed with the duration in seconds
day of discharge (approx. 5 - 10 days after operation)
Timed Up and Go (TUG)
Time Frame: twelve months
physical capacity expressed with the duration in seconds
twelve months
Six Minute Walk Test
Time Frame: twelve months
physical capacity expressed with the walking distance in meters
twelve months
Goal Attainment Scale (GAS)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected
day of discharge (approx. 5 - 10 days after operation)
Readiness for Hospital Discharge Scale (RHDS)
Time Frame: day of discharge (approx. 5 - 10 days after operation)
readiness for hospital discharge; 9 items, min 0, max 36, higher scores indicating higher readniss to discharge
day of discharge (approx. 5 - 10 days after operation)
5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L)
Time Frame: three months
health-related quality of life; 6 items, interpretation following an algorythm between 1 (best possible health condition) and <0 (worst possible health condition)
three months
5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L)
Time Frame: twelve months
health-related quality of life; 6 items, interpretation following an algorythm between 1 (best possible health condition) and <0 (worst possible health condition)
twelve months
Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA)
Time Frame: twelve months
use of health care services; 11 items collecting numbers of health care services and days of usage, min 0, higher scores indicating higher usage of services
twelve months

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.
Universitätsklinikum Hamburg-Eppendorf

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.
BARMER
University Hospital Augsburg

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: Evaldas Girdauskas, Prof., Universitätsklinikum Hamburg-Eppendorf

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

Helpful Links

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 1, 2021

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.
March 24, 2024

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.
June 30, 2024

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 18, 2021

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.
July 21, 2021

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.
July 26, 2021

Study Record Updates

Last Update Posted (Estimated)

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.
December 12, 2024

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.
December 8, 2024

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.
December 1, 2024

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.
  • 1564/108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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